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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01436175
Registration number
NCT01436175
Ethics application status
Date submitted
15/09/2011
Date registered
19/09/2011
Date last updated
14/06/2021
Titles & IDs
Public title
SPD489 Adult Major Depressive Disorder (MDD) Open-label Safety and Tolerability Rollover Extension Study
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Scientific title
A Phase 3, Open-label, Multicenter, 12-month Extension Safety and Tolerability Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder With Residual Symptoms or Inadequate Response Following Treatment With an Antidepressant
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Secondary ID [1]
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0
2011-003019-47
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Secondary ID [2]
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SPD489-329
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Major Depressive Disorder
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Condition category
Condition code
Mental Health
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0
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Depression
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SPD489 (Lisdexamfetamine dimesylate) + Antidepressant
Experimental: SPD489 + Antidepressant -
Treatment: Drugs: SPD489 (Lisdexamfetamine dimesylate) + Antidepressant
SPD489 20mg, 30mg, 50mg, or 70mg + Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily for 52 weeks
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Columbia-Suicide Severity Rating Scale (C-SSRS)
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Assessment method [1]
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C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviour during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.
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Timepoint [1]
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Week 5 up to Week 52/Early Termination(ET)
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Primary outcome [2]
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Change From Baseline in Systolic Blood Pressure at Week 52
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Assessment method [2]
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Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 \[NCT01435759\], SPD489-322 \[NCT01436149\], and SPD489-323 \[NCT01436162\]).
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Timepoint [2]
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Baseline, Week 52/ET
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Primary outcome [3]
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Change From Baseline in Diastolic Blood Pressure at Week 52
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Assessment method [3]
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Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 \[NCT01435759\], SPD489-322 \[NCT01436149\], and SPD489-323 \[NCT01436162\]).
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Timepoint [3]
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Baseline, Week 52/ET
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Primary outcome [4]
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Change From Baseline in Pulse Rate at Week 52
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Assessment method [4]
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Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 \[NCT01435759\], SPD489-322 \[NCT01436149\], and SPD489-323 \[NCT01436162\]).
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Timepoint [4]
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Baseline, Week 52/ET
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Secondary outcome [1]
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Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Week 52/ET
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Assessment method [1]
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Designed to evaluate the extent to which illness symptoms impact a participant's life in 3 areas: work, social, and family/home. Each area is scored on a scale from 0 (no impairment) to 10 (highly impaired) with a total score ranging from 0 (unimpaired) to 30 (highly impaired). Lower scores translate into less impairment. Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 \[NCT01435759\], SPD489-322 \[NCT01436149\], and SPD489-323 \[NCT01436162\]).
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Timepoint [1]
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Baseline, Week 52/ET
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Secondary outcome [2]
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Number of Participants With Improvement on Clinical Global Impressions - Global Improvement (CGI-I)
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Assessment method [2]
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Participants who did not have Clinical Global Impressions - Severity of Illness (CGI-S) assessed at Week 8 in the antecedent study should not have had CGI-I assessed in this study and were excluded from the summary of CGI-I. CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes a score of 1 (very much improved) or 2 (much improved) on the scale.
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Timepoint [2]
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Week 52/ET
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Secondary outcome [3]
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Short Form-12 Health Survey Version 2 (SF-12V2)
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Assessment method [3]
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SF-12V2 is a multi-purpose, 7-item survey that measures 8 domains of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It is expressed by two summary measures (Aggregate Physical and Aggregate Mental) for which values can range from 0 to 100. A higher score is indicative of a better health state.
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Timepoint [3]
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Week 52/ET
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Secondary outcome [4]
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EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Mobility
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Assessment method [4]
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Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses
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Timepoint [4]
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Week 52/ET
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Secondary outcome [5]
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EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Self-Care
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Assessment method [5]
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Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses
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Timepoint [5]
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Week 52/ET
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Secondary outcome [6]
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EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Usual Activities
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Assessment method [6]
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Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses
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Timepoint [6]
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Week 52/ET
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Secondary outcome [7]
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EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Pain/Discomfort
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Assessment method [7]
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Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses
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Timepoint [7]
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Week 52/ET
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Secondary outcome [8]
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EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Anxiety/Depression
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Assessment method [8]
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Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses
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Timepoint [8]
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Week 52/ET
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Secondary outcome [9]
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EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L): Visual Analog Scale
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Assessment method [9]
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EQ-5D-5L is one of the most widely used generic index measures of health-related quality of life. EQ-5D-5L Visual Analog Scale score is numbered from 0 to 100, where a score of 100 is the best health a participant can imagine
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Timepoint [9]
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Week 52/ET
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Secondary outcome [10]
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Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
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Assessment method [10]
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QIDS-SR is a validated, self-reported rating scale that contains 16 items scored on a scale from 0-3 with total scores ranging from 0 (no depression) to 27 (very severe depression). Lower scores indicate less depression. The QIDS-SR was only assessed in the SPD489-322 antecedent study. The QIDS-SR total score is calculated as the sum of the highest score on any 1 of Items 1-4, Item 5, the highest score on any 1 of Items 6-9, Items 10-14, the highest score on either Item 15 or 16.
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Timepoint [10]
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Week 52/ET
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Secondary outcome [11]
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Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF)
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Assessment method [11]
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The Q-LES-Q-SF is a 16-item self-report questionnaire which evaluates general participant satisfaction with health, mood, relationships, functioning in daily life, and their treatment. Each item is rated on a 5-point scale from 1 (very poor) to 5 (very good). The total raw score (summary scale score) was calculated by summing item scores 1 to 14 (total raw score range: 14 to 70). Item 15 (satisfaction with medication, raw score range: 1 to 5) and Item 16 (overall satisfaction and contentment; raw score range: 1 to 5) were stand-alone items. For reporting, summary scale, Item 15 and Item 16 raw scores were transformed into percentage maximum possible score which ranged from 0 to 100, where higher scores are indicative of greater enjoyment or satisfaction.
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Timepoint [11]
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Week 52/ET
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Secondary outcome [12]
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Change From Baseline in Sexual Functioning Questionnaire - 14 Item Scale (CSFQ-14) Total Score at Week 52/ET
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Assessment method [12]
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CSFQ-14 is a 14 item self-report tool that evaluates sexual functioning. Each item is scored on a 5-point Likert scale ranging from 1 (never) to 5 (always) with total scores ranging from 14 to 70. Higher scores reflect better sexual functioning. Baseline was defined as the Augmentation Baseline Visit of the antecedent study (SPD489-209 \[NCT01435759\], SPD489-322 \[NCT01436149\], and SPD489-323 \[NCT01436162\]).
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Timepoint [12]
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Baseline, Week 52/ET
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Secondary outcome [13]
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Amphetamine Cessation Symptom Assessment (ACSA) Total Score
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Assessment method [13]
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ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.
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Timepoint [13]
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Week 53
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Secondary outcome [14]
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Patient Resource Utilization Questionnaire - Major Depressive Disorder (PRUQ-MDD)
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Assessment method [14]
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The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered the following questions: 1. Were you hospitalized in the past month, 2. Do you work for pay, 3. If you missed time at work last week, please note all the reasons why, 4. Would you say that the past week was typical, like the rest of the 3 weeks this month, in terms of your working hours, 5. Do you do volunteer work (VW), and 6. If you do not receive money for your work and do not participate in volunteer work, the reason is. Number of participants with response is reported.
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Timepoint [14]
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Week 52/ET
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Secondary outcome [15]
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PRUQ-MDD - Number of Days of Resource Utilization
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Assessment method [15]
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The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Number of nights in medical/surgical ward, number of nights in ICU, and number of days a participant received home care in the past month are reported.
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Timepoint [15]
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Week 52/ET
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Secondary outcome [16]
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PRUQ-MDD - Number of Events (Visit to Health Care Provider/Visit to Hospital Facilities/Number of Times a Test Was Performed)
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Assessment method [16]
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The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions - 1. How many times did you visit the following healthcare providers in the past month: Family doctor/primary care, Non-physician healthcare practitioner (NPHP), Psychiatrist/Psychologist/Counselor (PPC); 2. How many times did you take one of the tests, mentioned below, during the past month: Blood test, CT Scan, X Ray, Renal function, Thyroid function; and 3. How many times did you visit the hospital emergency room (ER), urgent care facility (UCF) or an after-hours clinic (AHC) in the past month. Number of events (visit to health care provider, visit to hospital facilities, and number of times a test was performed) are reported.
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Timepoint [16]
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Week 52/ET
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Secondary outcome [17]
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PRUQ-MDD - Number of Hours
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Assessment method [17]
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The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions - 1. How many hours do you usually work or would you usually be expected to work (hrs/week); 2. How many hours did you actually work last week; 3. On average, how many hours do you volunteer per week. Number of hours are reported.
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Timepoint [17]
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Week 52/ET
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Secondary outcome [18]
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PRUQ-MDD - Effect of Depressive Symptoms
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Assessment method [18]
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The PRUQ-MDD assessed the long term economic outcomes. It collects utilization of healthcare resources reported by the study participants. Participants answered following questions on a 0 to 10 point scale - 1. During past week, how much did depressive symptoms affect work productivity; 2. During past week, how much did depressive symptoms affect regular non-work daily activities. Higher scores indicates more effect of depressive symptoms on work productivity and non-work daily activities.
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Timepoint [18]
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Week 52/ET
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Eligibility
Key inclusion criteria
* Subject has completed 1 of the respective short-term antecedent SPD489 MDD studies and did not experience any clinically significant AEs in the antecedent study that would preclude exposure to SPD489.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Subject has any current co-morbid Axis I or Axis II psychiatric disorder (including a lifetime history of psychosis) which was not present or recognized at entry into the antecedent study or has a concurrent chronic or acute illness or unstable medical condition that may deteriorate that could confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/02/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
27/03/2014
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Sample size
Target
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Accrual to date
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Final
1570
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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State/province [1]
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Alabama
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Indiana
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Kansas
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Missouri
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Nebraska
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Nevada
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New Jersey
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New Mexico
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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Tennessee
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Santiagio
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Chile
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Santiago
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Santiego
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Antofagasta
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Czechia
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Praha Vychod
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Brno
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Horovice
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Kutna Hora
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Czechia
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Litomerice
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Czechia
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Prague 10
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Prague
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Tallinn
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Tartu
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Finland
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Helsinki
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Finland
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Kuopio
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Finland
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Turku
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Germany
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Berlin
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Germany
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Germany
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Leipzig
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Germany
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Munchen
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Germany
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Nuernberg
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Germany
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Schwerin
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Germany
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Westerstede
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Germany
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Wuerzburg
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Hungary
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Budapest
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Hungary
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Debrecen
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Mexico
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Mazatian
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Mexico
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Monterrey
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Poland
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Bialystok
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Chelmno
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Gdansk
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Poland
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State/province [69]
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Gorlice
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Country [70]
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Poland
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State/province [70]
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Kielce
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Country [71]
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Poland
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State/province [71]
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Zuromin
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Country [72]
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Puerto Rico
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State/province [72]
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San Juan
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Country [73]
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Romania
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State/province [73]
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Bucuresti
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Country [74]
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Romania
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State/province [74]
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Targoviste
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Country [75]
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Romania
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Targu Mures
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South Africa
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Cape Town
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South Africa
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Western Cape
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Country [78]
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Spain
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State/province [78]
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Barcelona
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Country [79]
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Spain
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State/province [79]
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Madrid
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Country [80]
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Spain
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State/province [80]
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Oviedo
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Country [81]
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Spain
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State/province [81]
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Salamanca
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Country [82]
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Spain
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State/province [82]
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Zamora
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Country [83]
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Spain
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Zaragoza
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Shire
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is an optional continuation of previous short-term adult major depressive disorder (MDD) augmentation studies. Patients may only take part in this long-term, open-label research study if they completed a previous double-blind MDD augmentation study using SPD489.
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Trial website
https://clinicaltrials.gov/study/NCT01436175
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Study Director
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Takeda
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01436175
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