A double blind placebo controlled discontinuation of citalopram in adolescents with major depressio

Not Applicable

Completed

• Conditions: Major Depressive Disorder; Mental and Behavioural Disorders; Depression

• Registration Number: ISRCTN42386710
• Lead Sponsor: Sunnybrook and Women's College Health Sciences Centre (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-05
• Study Completion: 2006-03-31
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 214

Inclusion Criteria

1. Major depression determined from both clinical interview and the Kiddie-Sads-Present and Lifetime Version
(K-SADS-PL)
2. Subjects who score greater than 16 on the first 17 items of the 29 item Hamilton Rating Scale for Depression - Seasonal Affective Disorder (HRSD-SAD) version or those who score greater than 12 on the 17 item of the 29 items HRSD and greater than 7 on the atypical items
3. Age 13 to 18 years
4. Both sexes; females who have reached menarche and are sexually active will be advised to take adequate birth control (BCP or two barrier methods)
5. Outpatient at the time of initiation of the continuation phase
6. Ability to give informed consent

Exclusion Criteria

1. Past or currently hypomanic or manic episode
2. Currently meets criteria for conduct disorder
3. Current psychotic symptoms
4. Substance dependence in the last 3 months
5. Significant medical condition that would contra-indicate the use of antidepressant agents
6. Pregnancy
7. Past treatment with citalopram for major depression

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relapse = the subject meets criteria for an episode of major depression.

Secondary Outcome Measures

Name	Time	Method
A CGI-I score of -2 or -3 (on a 7 point scale) or more, reflecting at least 'moderate worsening' of the clinical condition.