Discontinuation Study Of Citalopram (Antidepressant) in Depressed Adolescents

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.

Study Overview

• Status: Withdrawn
• Conditions: Major Depression
• Intervention / Treatment: Drug: Citalopram

• Study Type: Interventional
• Enrollment: 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Relapse - subject meets criteria for an episode of major depression for 2 weeks or more.

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Anthony J Levitt, MD, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start: September 1, 2002
• Study Completion: November 1, 2006

Study Registration Dates

• First Submitted: November 3, 2005
• First Submitted That Met QC Criteria: November 4, 2005
• First Posted (Estimate): November 7, 2005

Study Record Updates

• Last Update Posted (Estimate): September 19, 2006
• Last Update Submitted That Met QC Criteria: September 18, 2006
• Last Verified: November 1, 2005

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Citalopram
• Other Study ID Numbers: ISRCTN42386710