Discontinuation Study Of Citalopram (Antidepressant) in Depressed Adolescents

Major Depression Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00249886
• Other study ID #: ISRCTN42386710
• Status: Withdrawn
• Phase: Phase 3
• First received: November 3, 2005
• Last updated: September 18, 2006
• Start date: September 2002
• Est. completion date: November 2006

Study information

• Verified date: November 2005
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 60
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depressive Disorder, Major
• Major Depression

Intervention

Drug:
• Citalopram

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse - subject meets criteria for an episode of major depression for 2 weeks or more.