Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00156325




Registration number
NCT00156325
Ethics application status
Date submitted
8/09/2005
Date registered
12/09/2005
Date last updated
2/01/2006

Titles & IDs
Public title
Escitalopram as a Mood Stabilizer for Bipolar II Disorder
Scientific title
A Double-Blind, Placebo-Controlled Trial of Escitalopram as a Mood Stabilizer for Bipolar II Disorder
Secondary ID [1] 0 0
03283
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar Disorders 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency, Severity and duration of depressive and hypomanic episodes and impairment.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
* Aged 18-65
* Minimum two year history of depressive and hypomanic episodes
* Mood episodes occuring monthly
* Meet DSM-IV criteria for Bipolar II Disorder (with exception of minimum 4 day period for hypomanic episodes)
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Previous treatment with any antidepressant, mood stabilizer or neuroleptic medication
* History of psychotic symptoms during hypomanic or depressive episodes
* Current suicidal behaviours
* Current substantive illicit drug use or alcohol consumption
* Significant personality disorder
* Pregnancy or breastfeeding
* History of heart disease, liver disease, epilepsy or seizures

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
University of New South Wales - Sydney
Recruitment postcode(s) [1] 0 0
2031 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gordon Parker
Address 0 0
Black Dog Institute/School of Psychiatry, University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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 not provided in https://clinicaltrials.gov/study/NCT00156325