Back to resultsDiscontinuation Study Of Citalopram (Antidepressant) in Depressed Adolescents
Primary Purpose
Major Depression
Status
Withdrawn
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Citalopram
Sponsored by
About this trial
This is an interventional treatment trial for Major Depression
Eligibility Criteria
Inclusion Criteria: Diagnosis of major Depression. Age 13-18. A score of > 16 on the 17 item Hamilton Depression Scale or a score of > 12 on the 17 items plus a score of >7 on the atypical items. Males and females. Outpatient at initiation of double blind treatment phase. Ability to give informed consent. Exclusion Criteria: Past or current hypomanic or manic episode. Currently meets criteria for a Conduct Disorder. Current psychotic symptoms. Substance dependence in the last 3 months. Significant medical condition that would contraindicate the use of an antidepressant. Pregnancy Past treatment with Citalopram for major depression
Sites / Locations
- Sunnybrook Health Sciences Centre
Outcomes
Primary Outcome Measures
Relapse - subject meets criteria for an episode of major depression for 2 weeks or more.
Secondary Outcome Measures
Full Information
NCT ID
NCT00249886
First Posted
November 3, 2005
Last Updated
September 18, 2006
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT00249886
Brief Title
Discontinuation Study Of Citalopram (Antidepressant) in Depressed Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
November 2005
Overall Recruitment Status
Withdrawn
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
5. Study Description
Brief Summary
The purpose of the study is to evaluate whether it is advantageous for adolescents who have recovered from depression after a 6 to 12 week course of antidepressant treatment to stay on the treatment a further 6 months or is it just as helpful to stop the medication after recovery.
The hypothesis is that adolescents with major depression who recover from the 6 to 12 week trial of citalopram will be less likely to have a recurrence of depression over a 6 month period if continued on the citalopram as compared to those who discontinue the medication.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Citalopram
Primary Outcome Measure Information:
Title
Relapse - subject meets criteria for an episode of major depression for 2 weeks or more.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of major Depression.
Age 13-18.
A score of > 16 on the 17 item Hamilton Depression Scale or a score of > 12 on the 17 items plus a score of >7 on the atypical items.
Males and females.
Outpatient at initiation of double blind treatment phase.
Ability to give informed consent.
Exclusion Criteria:
Past or current hypomanic or manic episode.
Currently meets criteria for a Conduct Disorder.
Current psychotic symptoms.
Substance dependence in the last 3 months.
Significant medical condition that would contraindicate the use of an antidepressant.
Pregnancy
Past treatment with Citalopram for major depression
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony J Levitt, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Discontinuation Study Of Citalopram (Antidepressant) in Depressed Adolescents
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