A double blind placebo controlled discontinuation of citalopram in adolescents with major depression

ISRCTN	ISRCTN42386710
DOI	https://doi.org/10.1186/ISRCTN42386710
ClinicalTrials.gov number	NCT00249886
Secondary identifying numbers	MCT-53732

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Anthony Joseph Levitt
Scientific

2075 Bayview Av
Toronto
M4N 3M5
Canada

Study design	Double blind placebo controlled discontinuation
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title	A double blind placebo controlled discontinuation of citalopram in adolescents with major depression
Study objectives	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(s)	Sunnybrook Hospital University of Toronto Clinic, 24/09/2002
Health condition(s) or problem(s) studied	Major Depressive Disorder
Intervention	Citalopram versus placebo
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Citalopram
Primary outcome measure	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 study start date	01/04/2002
Completion date	31/03/2006

Participant type(s)	Patient
Age group	Child
Lower age limit	13 Years
Upper age limit	18 Years
Sex	Not Specified
Target number of participants	214
Key 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
Key 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
Date of first enrolment	01/04/2002
Date of final enrolment	31/03/2006

2075 Bayview Av

Toronto
M4N 3M5
Canada

Sunnybrook and Women's College Health Sciences Centre (Canada)
Not defined

2075 Bayview Avenue
Toronto
M4N 3M5
Canada

"ROR"	https://ror.org/03wefcv03

Research organisation

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

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

28/01/2019: Clinicaltrials.gov stated that the trial was terminated by September 2006