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Discontinuation Study Of Citalopram (Antidepressant) in Depressed Adolescents

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00249886
First received: November 3, 2005
Last updated: September 18, 2006
Last verified: November 2005
History of Changes
  Purpose

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 Intervention Phase
Major Depression
 Drug: Citalopram
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sunnybrook Health Sciences Centre:

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

Estimated Enrollment: 60
Study Start Date: September 2002
Estimated Study Completion Date: November 2006
  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00249886

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

Additional Information:
Treatment of mood disorders across the life span, examining both pharmacological and psychotherapeutic treatment.  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00249886     History of Changes
Other Study ID Numbers: ISRCTN42386710
Study First Received: November 3, 2005
Last Updated: September 18, 2006
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Citalopram
Dexetimide
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antidepressive Agents, Second-Generation
 Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on June 13, 2013