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Maintenance Study for Adolescent Depression (MTAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00508859
Recruitment Status : Completed
First Posted : July 30, 2007
Last Update Posted : July 30, 2007
Medical Research Council
Information provided by:
Sunnybrook Health Sciences Centre

Brief 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.

Condition or disease Intervention/treatment Phase
Depression Drug: Sertraline Drug: placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : July 1997

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Active, 1
Drug: Sertraline
maintenance treatment with sertraline
Other Name: zoloft

Placebo Comparator: Placebo
Drug: placebo

Primary Outcome Measures :
  1. recurrence of depression [ Time Frame: 52 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00508859

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Canada, British Columbia
Vancouver, British Columbia, Canada
Canada, Nova Scotia
Dalhousie University
Halifax, Nova Scotia, Canada, B3K 6R8
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Medical Research Council
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Principal Investigator: Anthony Levitt, MD Sunnybrook Health Sciences Centre

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00508859    
Other Study ID Numbers: 0831997
First Posted: July 30, 2007    Key Record Dates
Last Update Posted: July 30, 2007
Last Verified: July 2007
Keywords provided by Sunnybrook Health Sciences Centre:
maintenance treatment
Additional relevant MeSH terms:
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Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs