Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00088465
Registration number
NCT00088465
Ethics application status
Date submitted
26/07/2004
Date registered
27/07/2004
Date last updated
11/01/2012
Titles & IDs
Public title
Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder
Query!
Scientific title
An Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder
Query!
Secondary ID [1]
0
0
F1D-MC-HGKB
Query!
Secondary ID [2]
0
0
5995
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Schizophrenic Disorders
0
0
Query!
Schizoaffective Disorder
0
0
Query!
Condition category
Condition code
Mental Health
0
0
0
0
Query!
Schizophrenia
Query!
Mental Health
0
0
0
0
Query!
Psychosis and personality disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Intramuscular olanzapine depot
Experimental: Intramuscular Olanzapine Depot - Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
Treatment: Drugs: Intramuscular olanzapine depot
45-405 milligram (mg), intramuscular injection, on a 2-, 3-, or 4-week interval.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Participants With Adverse Events (AE)
Query!
Assessment method [1]
0
0
The list of serious adverse events (SAE) and other non-serious adverse events (AE) are in Adverse Events Section.
Query!
Timepoint [1]
0
0
Randomization to end of study up to 76 months
Query!
Primary outcome [2]
0
0
Number of Participants With Treatment-Emergent Abnormal High Prolactin at Any Time Post Baseline
Query!
Assessment method [2]
0
0
Prolactin normal reference ranges for female: 2.0 - 29.0 nanograms per milliliter (ng/mL); male: 2.0 - 20.0 ng/mL. High value is defined as a change from a value less than or equal to the high limit at all baseline visits to a value greater than the high limit at any time after baseline.
Query!
Timepoint [2]
0
0
Randomization to end of study up to 76 months
Query!
Primary outcome [3]
0
0
Number of Participants With Treatment-Emergent Abnormal High Alanine Transaminase (ALT), High Aspartate Transaminase (AST), High Total Bilirubin at Any Time Post Baseline
Query!
Assessment method [3]
0
0
High ALT is defined as a baseline value of \<3 times the upper limit of normal (ULN) to =3 times the ULN at any time post baseline. High AST is defined as a baseline value of \<5 times the ULN to =5 times the ULN at any time post baseline. High total bilirubin is defined as a baseline value of \<2 times the ULN to =2 times the ULN at any time post baseline.
Query!
Timepoint [3]
0
0
Randomization to end of study up to 76 months
Query!
Primary outcome [4]
0
0
Number of Participants Having Normal Fasting Baseline Glucose Value With Treatment-Emergent High Fasting Glucose at Any Time Post Baseline
Query!
Assessment method [4]
0
0
Normal to high fasting glucose =100 milligrams per deciliter (mg/dL) at baseline to =126 mg/dL any time post baseline.
Query!
Timepoint [4]
0
0
Randomization to end of study up to 76 months
Query!
Primary outcome [5]
0
0
Number of Participants Having Normal Fasting Baseline Lipid Value With Treatment-Emergent High Fasting Lipid at Any Time Post Baseline
Query!
Assessment method [5]
0
0
Normal to high fasting total cholesterol =200 mg/dL at baseline to =240 mg/dL any time post baseline. Fasting triglycerides \<150 mg/dL at baseline to =200 mg/dL and \<500 mg/dL any time post baseline.
Query!
Timepoint [5]
0
0
Randomization to end of study up to 76 months
Query!
Primary outcome [6]
0
0
Change From Baseline in Weight at Month 76 Endpoint
Query!
Assessment method [6]
0
0
Mean change in weight from baseline to last observation carried forward (LOCF) endpoint.
Query!
Timepoint [6]
0
0
Baseline, up to 76 months
Query!
Primary outcome [7]
0
0
Number of Participants With Potentially Clinically Significant (PCS) Weight Gain at Month 76 Endpoint
Query!
Assessment method [7]
0
0
PCS weight gain is defined as a =7% increase in weight from baseline.
Query!
Timepoint [7]
0
0
Randomization to end of study up to 76 months
Query!
Primary outcome [8]
0
0
Number of Participants With Extrapyramidal Symptoms at Any Time
Query!
Assessment method [8]
0
0
Extrapyramidal symptoms are defined as Simpson-Angus total score (SAS) \>3 at any post-baseline visit; Barnes Akathisia Scale (BAS) global score =2 at any post-baseline visit; A score =3 for any of Abnormal Involuntary Movement Scale (AIMS) for items 1-7 or a score =2 for any two of these items. Score for SAS is 0-4 for each of the 10 questions, with 0=normal and 4=extreme. The possible total score for SAS is 0-40. Possible score for BAS is 0-5, with 0=absent and 5=sever. Score 0-4 for each item of AIMS, with 0 =none and 4= sever. Possible total score for items 1-7 is 0-28.
Query!
Timepoint [8]
0
0
Randomization to end of study up to 76 months
Query!
Secondary outcome [1]
0
0
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Month 76 Endpoint
Query!
Assessment method [1]
0
0
Assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210.
Query!
Timepoint [1]
0
0
Baseline, up to 76 months
Query!
Secondary outcome [2]
0
0
Change From Baseline in PANSS Positive Scores at Month 76 Endpoint
Query!
Assessment method [2]
0
0
PANSS questions 1-7. Assesses positive symptoms associated with schizophrenia. 7 items make up the positive scale (ex. delusions, conceptual disorganization, and hallucinatory behavior). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total positive subscale scores range from 7 to 49.
Query!
Timepoint [2]
0
0
Baseline, up to 76 months
Query!
Secondary outcome [3]
0
0
Change From Baseline in PANSS Negative Scores at Month 76 Endpoint
Query!
Assessment method [3]
0
0
PANSS questions 8-14. Assesses negative symptoms associated with schizophrenia. 7 items make up the negative scale (e.g. blunted affect, emotional withdrawal, poor rapport, and passive/apathetic social withdrawal). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total negative subscale scores range from 7 to 49.
Query!
Timepoint [3]
0
0
Baseline, up to 76 months
Query!
Secondary outcome [4]
0
0
Change From Baseline in PANSS General Psychopathology Subscales at Month 76 Endpoint
Query!
Assessment method [4]
0
0
PANSS General Psychopathology Subscale is the Remaining 16 PANSS questions or PANSS Question15 through Question 30. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 16 items is defined as the PANSS General Psychopathology Subscales. Possible score ranges from 16 to 112.
Query!
Timepoint [4]
0
0
Baseline, up to 76 months
Query!
Secondary outcome [5]
0
0
Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Scores at Month 72 Endpoint
Query!
Assessment method [5]
0
0
Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Query!
Timepoint [5]
0
0
Baseline, up to 72 months
Query!
Secondary outcome [6]
0
0
Change From Baseline in the Heinrichs-Carpenter Quality of Life Scale (QLS) Total Score at Month 76 Endpoint
Query!
Assessment method [6]
0
0
Heinrich-Carpenter QLS is an interviewer-rated scale which measures the impact of negative symptoms on occupational, social, and psychological functioning in patients with schizophrenia or schizoaffective disorder. Each of 21 items is rated on a scale from 0 (severely impaired functioning) to 6 (normal or adequate functioning), for a total score range of 0-126. Results are presented as change in Total score.
Query!
Timepoint [6]
0
0
Baseline, up to 76 months
Query!
Secondary outcome [7]
0
0
Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Month 76 Endpoint
Query!
Assessment method [7]
0
0
A self-reported questionnaire that consists of 36 questions covering 8 health domains (physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The mental component summary (MCS) and the physical component summary (PCS) have been constructed based on the 8 SF-36 domains.
Query!
Timepoint [7]
0
0
Baseline, up to 76 months
Query!
Secondary outcome [8]
0
0
Number of Psychiatric Visits
Query!
Assessment method [8]
0
0
Psychiatric visits were outpatient visits to a psychiatrist or psychiatric nurse.
Query!
Timepoint [8]
0
0
Randomization to end of study up to 76 months
Query!
Secondary outcome [9]
0
0
Days of Hospitalization
Query!
Assessment method [9]
0
0
This is the total number of days for all hospitalized patients that were admitted to General, Psychiatric Ward as well as Intensive Care Unit (ICU).
Query!
Timepoint [9]
0
0
Randomization to end of study up to 76 months
Query!
Secondary outcome [10]
0
0
Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) at Month 76 Endpoint
Query!
Assessment method [10]
0
0
The Subjective Well-Being under Neuroleptic Treatment-Short Form (SWN-S) is a patient self-rated scale developed to measure the subjective well-being for the previous 7 days of a patient under neuroleptic treatment. The SWN-S consists of 20 items (each item is rated from 1=not at all to 6=very much). Possible total score ranges from 20-120.
Query!
Timepoint [10]
0
0
Baseline, up to 76 months
Query!
Secondary outcome [11]
0
0
Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at Month 76 Endpoint
Query!
Assessment method [11]
0
0
Self-rated scale that measures patient's level of satisfaction with current antipsychotic medication. Consists of 3 items assessing satisfaction with current study medication (scored from 1='very dissatisfied' to 5='very satisfied'), preference comparing current study medication versus previous medications (scored from 1='much prefer previous medication' to 5='much prefer study medication'), and side effects of current study medication compared with previous medications (scored from 1='much less side effects' to 5='much more side effects'). Range of possible scores is 3-15.
Query!
Timepoint [11]
0
0
Randomization to end of study up to 76 months
Query!
Secondary outcome [12]
0
0
Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year
Query!
Assessment method [12]
0
0
Plasma olanzapine concentrations are expressed as (nanogram/milliliter)/(milligram/day) (\[ng/mL\]/\[mg/day\]).
Query!
Timepoint [12]
0
0
Randomization to end of study up to 76 months
Query!
Eligibility
Key inclusion criteria
* Patients must have schizophrenia
* Female patients of childbearing potential must be using a medically accepted means of contraception
* Patients must have completed (within 10 days) another IM olanzapine depot study if permitted by that study's protocol.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
76
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Patients must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to study entry
* Female patients must not be pregnant or breast-feeding
* Patients must not be experiencing acute, serious or unstable medical conditions other than schizophrenia or schizoaffective disorder
* Patients must not have a substance (except nicotine or caffeine) dependence within the past 30 days
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/08/2004
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/12/2010
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
931
Query!
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Herston
Query!
Recruitment hospital [2]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Glenside
Query!
Recruitment hospital [3]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Dandenong
Query!
Recruitment postcode(s) [1]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [2]
0
0
5065 - Glenside
Query!
Recruitment postcode(s) [3]
0
0
3175 - Dandenong
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
District of Columbia
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Hawaii
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Illinois
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Indiana
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Louisiana
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Missouri
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Nevada
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
New Mexico
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
New York
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Ohio
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Texas
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Washington
Query!
Country [15]
0
0
Argentina
Query!
State/province [15]
0
0
Buenos Aires
Query!
Country [16]
0
0
Argentina
Query!
State/province [16]
0
0
Lanus Este
Query!
Country [17]
0
0
Argentina
Query!
State/province [17]
0
0
Mendoza
Query!
Country [18]
0
0
Austria
Query!
State/province [18]
0
0
Wien
Query!
Country [19]
0
0
Belgium
Query!
State/province [19]
0
0
Diest
Query!
Country [20]
0
0
Belgium
Query!
State/province [20]
0
0
Liège
Query!
Country [21]
0
0
Brazil
Query!
State/province [21]
0
0
Aparecida De Goiania
Query!
Country [22]
0
0
Brazil
Query!
State/province [22]
0
0
Rio De Janeiro
Query!
Country [23]
0
0
Brazil
Query!
State/province [23]
0
0
Salvador
Query!
Country [24]
0
0
Croatia
Query!
State/province [24]
0
0
Zagreb
Query!
Country [25]
0
0
Czech Republic
Query!
State/province [25]
0
0
Prague
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Bayonne
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Bourg En Bresse
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Dijon
Query!
Country [29]
0
0
France
Query!
State/province [29]
0
0
Dole
Query!
Country [30]
0
0
France
Query!
State/province [30]
0
0
Fontaine
Query!
Country [31]
0
0
France
Query!
State/province [31]
0
0
La Roche Sur Foron
Query!
Country [32]
0
0
France
Query!
State/province [32]
0
0
La Seyne Sur Mer
Query!
Country [33]
0
0
France
Query!
State/province [33]
0
0
Limoges
Query!
Country [34]
0
0
France
Query!
State/province [34]
0
0
Narbonne
Query!
Country [35]
0
0
France
Query!
State/province [35]
0
0
Paris
Query!
Country [36]
0
0
France
Query!
State/province [36]
0
0
Saint Cyr Au Mont D'Or
Query!
Country [37]
0
0
France
Query!
State/province [37]
0
0
Strasbourg
Query!
Country [38]
0
0
France
Query!
State/province [38]
0
0
Suresnes
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Bad Saarow
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Berlin
Query!
Country [41]
0
0
Germany
Query!
State/province [41]
0
0
Halle
Query!
Country [42]
0
0
Germany
Query!
State/province [42]
0
0
Hamburg
Query!
Country [43]
0
0
Germany
Query!
State/province [43]
0
0
Mainz
Query!
Country [44]
0
0
Germany
Query!
State/province [44]
0
0
München
Query!
Country [45]
0
0
Hungary
Query!
State/province [45]
0
0
Budapest
Query!
Country [46]
0
0
Israel
Query!
State/province [46]
0
0
Beer Yaacov
Query!
Country [47]
0
0
Israel
Query!
State/province [47]
0
0
Hod-Hasharon
Query!
Country [48]
0
0
Israel
Query!
State/province [48]
0
0
Lev Hasharon
Query!
Country [49]
0
0
Italy
Query!
State/province [49]
0
0
Firenze
Query!
Country [50]
0
0
Italy
Query!
State/province [50]
0
0
Savigliano
Query!
Country [51]
0
0
Italy
Query!
State/province [51]
0
0
Torino
Query!
Country [52]
0
0
Mexico
Query!
State/province [52]
0
0
Guadalajara
Query!
Country [53]
0
0
Mexico
Query!
State/province [53]
0
0
Mexico City
Query!
Country [54]
0
0
Mexico
Query!
State/province [54]
0
0
Monterrey
Query!
Country [55]
0
0
Netherlands
Query!
State/province [55]
0
0
Den Haag
Query!
Country [56]
0
0
Netherlands
Query!
State/province [56]
0
0
Enschede
Query!
Country [57]
0
0
Poland
Query!
State/province [57]
0
0
Gdynia
Query!
Country [58]
0
0
Poland
Query!
State/province [58]
0
0
Torun
Query!
Country [59]
0
0
Portugal
Query!
State/province [59]
0
0
Braga
Query!
Country [60]
0
0
Portugal
Query!
State/province [60]
0
0
Coimbra
Query!
Country [61]
0
0
Portugal
Query!
State/province [61]
0
0
Lisbon
Query!
Country [62]
0
0
Portugal
Query!
State/province [62]
0
0
Porto
Query!
Country [63]
0
0
Puerto Rico
Query!
State/province [63]
0
0
Mayaguez
Query!
Country [64]
0
0
Puerto Rico
Query!
State/province [64]
0
0
Ponce
Query!
Country [65]
0
0
Puerto Rico
Query!
State/province [65]
0
0
Rio Piedras
Query!
Country [66]
0
0
Puerto Rico
Query!
State/province [66]
0
0
San Juan
Query!
Country [67]
0
0
Romania
Query!
State/province [67]
0
0
Bucharest
Query!
Country [68]
0
0
Romania
Query!
State/province [68]
0
0
Craiova
Query!
Country [69]
0
0
Romania
Query!
State/province [69]
0
0
Iasi
Query!
Country [70]
0
0
Russian Federation
Query!
State/province [70]
0
0
Moscow
Query!
Country [71]
0
0
Russian Federation
Query!
State/province [71]
0
0
Saint Petersburg
Query!
Country [72]
0
0
Slovakia
Query!
State/province [72]
0
0
Bratislava
Query!
Country [73]
0
0
South Africa
Query!
State/province [73]
0
0
George
Query!
Country [74]
0
0
South Africa
Query!
State/province [74]
0
0
Randburg
Query!
Country [75]
0
0
Spain
Query!
State/province [75]
0
0
Barcelona
Query!
Country [76]
0
0
Spain
Query!
State/province [76]
0
0
Burgos
Query!
Country [77]
0
0
Spain
Query!
State/province [77]
0
0
Málaga
Query!
Country [78]
0
0
Spain
Query!
State/province [78]
0
0
Sevilla
Query!
Country [79]
0
0
Sweden
Query!
State/province [79]
0
0
Falköping
Query!
Country [80]
0
0
Sweden
Query!
State/province [80]
0
0
Stockholm
Query!
Country [81]
0
0
Taiwan
Query!
State/province [81]
0
0
Taipei
Query!
Country [82]
0
0
Taiwan
Query!
State/province [82]
0
0
Tao-Yuan
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Eli Lilly and Company
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This is a long-term, open-label clinical study designed to enable longer-term treatment of patients completing other clinical studies with intramuscular olanzapine depot. Key objectives of the study are to: * Determine how well intramuscular (IM) olanzapine depot works during long-term treatment, * Evaluate the safety and tolerability of IM olanzapine depot during long-term treatment, * Determine the blood levels of IM olanzapine depot in patients during long-term treatment
Query!
Trial website
https://clinicaltrials.gov/study/NCT00088465
Query!
Trial related presentations / publications
McDonnell DP, Landry J, Detke HC. Long-term safety and efficacy of olanzapine long-acting injection in patients with schizophrenia or schizoaffective disorder: a 6-year, multinational, single-arm, open-label study. Int Clin Psychopharmacol. 2014 Nov;29(6):322-31. doi: 10.1097/YIC.0000000000000038. Atkins S, Detke HC, McDonnell DP, Case MG, Wang S. A pooled analysis of injection site-related adverse events in patients with schizophrenia treated with olanzapine long-acting injection. BMC Psychiatry. 2014 Jan 14;14:7. doi: 10.1186/1471-244X-14-7. Peuskens J, Porsdal V, Pecenak J, Handest P, D'yachkova Y, Brousil R, Deberdt W. Schizophrenia symptoms and functioning in patients receiving long-term treatment with olanzapine long-acting injection formulation: a pooled analysis. BMC Psychiatry. 2012 Aug 31;12:130. doi: 10.1186/1471-244X-12-130. McDonnell DP, Detke HC, Bergstrom RF, Kothare P, Johnson J, Stickelmeyer M, Sanchez-Felix MV, Sorsaburu S, Mitchell MI. Post-injection delirium/sedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, II: investigations of mechanism. BMC Psychiatry. 2010 Jun 10;10:45. doi: 10.1186/1471-244X-10-45. Detke HC, McDonnell DP, Brunner E, Zhao F, Sorsaburu S, Stefaniak VJ, Corya SA. Post-injection delirium/sedation syndrome in patients with schizophrenia treated with olanzapine long-acting injection, I: analysis of cases. BMC Psychiatry. 2010 Jun 10;10:43. doi: 10.1186/1471-244X-10-43.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Query!
Address
0
0
Eli Lilly and Company
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
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/NCT00088465
Download to PDF