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Discontinuation Study Of Citalopram (Antidepressant) in Depressed Adolescents

NCT ID: NCT00249886

Last Updated: 2006-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2006-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Major Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Citalopram

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Principal Investigators

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Anthony J Levitt, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

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Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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ISRCTN42386710

Identifier Type: -

Identifier Source: org_study_id