Maintenance Study for Adolescent Depression
Information source: Sunnybrook Health Sciences Centre
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression
Intervention: Sertraline (Drug); placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Sunnybrook Health Sciences Centre Official(s) and/or principal investigator(s): Anthony Levitt, MD, Principal Investigator, Affiliation: Sunnybrook Health Sciences Centre
Summary
This study examined the benefit of continued treatment with an antidepressant medication,
sertraline, in adolescents with depression who improved on sertraline acutely. We
hypothesize that adolescents who remained on sertraline long term were less likely to have a
recurrence of depression compared to those on placebo.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Primary outcome: recurrence of depression
Detailed description:
This study was designed as a randomized controlled trial of maintenance treatment of
sertraline in adolescents aged 13-19 with depression.
Subjects Subjects aged 13-19 were recruited, over 18 months, at mood disorders clinics in 3
tertiary care centres across Canada. Informed consent was obtained from eligible and
interested subjects and parents (if subject <16 years of age). Subjects were eligible for
entry into the study if they had a diagnosis of Major Depression determined from both
clinical interview and the Schedule for Affective Disorders and Schizophrenia for Children
(K-SAD-PL) and scored > 16 on the first 17 items of the 29-item Hamilton Rating Scale for
Depression (HAM-D). Subjects were excluded if they had past or current hypomanic or manic
episode, current psychotic symptoms, substance dependence in the last 3 months, significant
medical condition that would contra-indicate the use of antidepressants or that if untreated
may require medical attention, pregnancy, or past treatment with sertraline for major
depression.
Interventions and Procedures There were 3 phase to the study: 1) a 12-week acute phase, 2)
a 24-week continuation phase, and 3) a 52-week maintenance phase. In general, subjects were
assessed every 2 weeks throughout the study except during the first 4 weeks of the
maintenance phase when they were seen or contacted weekly. In the continuation and
maintenance phases, every 2nd visit was conducted in person while the other assessments
could be conducted either by telephone or in person.
Initial sertraline dose during the acute phase was either 25 mg or 50 mg daily with
increases of 25 to 50 mg every 2 weeks at the treating clinicians' discretion, up to a
maximum of 200 mg daily. For responders who entered the continuation phase and had some
re-emergence of symptoms without relapse, dose increases with sertraline were permitted
every 2 weeks to a maximum dose of 200 mg daily but only during the first 8 weeks of the
continuation phase. If a subject experienced side effects, one dose decrease was permitted
in the first 8 weeks of the continuation phase. Subjects who maintained response during
continuation were then randomized to continue sertraline or to take placebo. In the placebo
group, sertraline was tapered by 25% of the initial dose every week for the first 4 weeks of
the maintenance phase. During the maintenance phase, no treatment changes were permitted.
Subjects who responded to acute phase treatment, defined as 2 consecutive HAMD < 9 and
greater than a 50% reduction in HAM-D score within 12 weeks, were offered entry into the
continuation phase. Inter-rater reliability for the HAM-D was tested annually with site
project coordinators and research assistants. Further training and evaluation were
implemented until the inter-rater reliability was 0. 8 or greater. Relapse during the
continuation and recurrence during maintenance phases were determined according to the
clinical judgement of the treating physician that the major depression had recurred or an
intervention beyond what was permitted by the study protocol was required.
Adverse events were collected using the Common Adverse and Side Effects Scale. The scale
was administered every 2 weeks during the acute phase and every 4 weeks during the
continuation and maintenance phase.
Blinding and Randomization Randomization was conducted by the study pharmacist using a
computer generated randomization schedule. Subjects, clinicians and research staff remained
blinded to treatment during the randomization phase. All statistical analyses were
conducted by an independent statistician blinded to patient allocation.
Eligibility
Minimum age: 13 Years.
Maximum age: 19 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age 13-19
- Diagnosis of Major Depression
Exclusion Criteria:
- History of mania/hypomania
- Current psychotic symptoms
- Substance dependence
- Medical conditions (contraindication for sertraline)
- Pregnancy
- Past treatment with sertraline
Locations and Contacts
UBC, Vancouver, British Columbia, Canada
Dalhousie University, Halifax, Nova Scotia B3K 6R8, Canada
Additional Information
Starting date: July 1997
Last updated: July 27, 2007
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