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Discontinuation Study Of Citalopram (Antidepressant) in Depressed Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00249886
Recruitment Status : Withdrawn
First Posted : November 7, 2005
Last Update Posted : September 19, 2006
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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.

Condition or disease Intervention/treatment Phase
Major Depression Drug: Citalopram Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : September 2002
Estimated Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Relapse - subject meets criteria for an episode of major depression for 2 weeks or more.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00249886

Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Principal Investigator: Anthony J Levitt, MD Sunnybrook Health Sciences Centre
More Information

ClinicalTrials.gov Identifier: NCT00249886     History of Changes
Other Study ID Numbers: ISRCTN42386710
First Posted: November 7, 2005    Key Record Dates
Last Update Posted: September 19, 2006
Last Verified: November 2005

Additional relevant MeSH terms:
Depressive Disorder, Major
Depressive Disorder
Mood Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents