Condition category
Mental and Behavioural Disorders
Date applied
05/09/2005
Date assigned
05/09/2005
Last edited
12/11/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anthony Joseph Levitt

ORCID ID

Contact details

2075 Bayview Av
Toronto
M4N 3M5
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00249886

Protocol/serial number

MCT-53732

Study information

Scientific title

Acronym

Study hypothesis

Adolescents with Major Depression who recover from an acute trial of citalopram will have a lower relapse rate over a 6 month period when continued on citalopram as compared to subjects randomly assigned to discontinue to placebo.

Ethics approval

Sunnybrook Hospital University of Toronto Clinic, 24/09/2002

Study design

Double blind placebo controlled discontinuation

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Major Depressive Disorder

Intervention

Citalopram versus placebo

Intervention type

Drug

Phase

Not Specified

Drug names

Citalopram

Primary outcome measures

Relapse = the subject meets criteria for an episode of major depression.

Secondary outcome measures

A CGI-I score of -2 or -3 (on a 7 point scale) or more, reflecting at least 'moderate worsening' of the clinical condition.

Overall trial start date

01/04/2002

Overall trial end date

31/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Major depression determined from both clinical interview and the Kiddie-Sads-Present and Lifetime Version
(K-SADS-PL)
2. Subjects who score greater than 16 on the first 17 items of the 29 item Hamilton Rating Scale for Depression - Seasonal Affective Disorder (HRSD-SAD) version or those who score greater than 12 on the 17 item of the 29 items HRSD and greater than 7 on the atypical items
3. Age 13 to 18 years
4. Both sexes; females who have reached menarche and are sexually active will be advised to take adequate birth control (BCP or two barrier methods)
5. Outpatient at the time of initiation of the continuation phase
6. Ability to give informed consent

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

214

Participant exclusion criteria

1. Past or currently hypomanic or manic episode
2. Currently meets criteria for conduct disorder
3. Current psychotic symptoms
4. Substance dependence in the last 3 months
5. Significant medical condition that would contra-indicate the use of antidepressant agents
6. Pregnancy
7. Past treatment with citalopram for major depression

Recruitment start date

01/04/2002

Recruitment end date

31/03/2006

Locations

Countries of recruitment

Canada

Trial participating centre

2075 Bayview Av
Toronto
M4N 3M5
Canada

Sponsor information

Organisation

Sunnybrook and Women's College Health Sciences Centre (Canada)

Sponsor details

2075 Bayview Avenue
Toronto
M4N 3M5
Canada

Sponsor type

Not defined

Website

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-53732)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes