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This study has been withdrawn prior to enrollment.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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

ClinicalTrials.gov processed this record on September 16, 2014