Maintenance Study for Adolescent Depression (MTAD)

This study has been completed.
Sponsor:
Collaborator:
Medical Research Council
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00508859
First received: July 26, 2007
Last updated: July 27, 2007
Last verified: July 2007
  Purpose

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 Intervention Phase
Depression
Drug: Sertraline
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

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

Enrollment: 93
Study Start Date: July 1997
Arms Assigned Interventions
Experimental: Active, 1
sertraline
Drug: Sertraline
maintenance treatment with sertraline
Other Name: zoloft
Placebo Comparator: Placebo
placebo
Drug: placebo
placebo

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

Ages Eligible for Study:   13 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00508859

Locations
Canada, British Columbia
UBC
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
Investigators
Principal Investigator: Anthony Levitt, MD Sunnybrook Health Sciences Centre
  More Information

No publications provided by Sunnybrook Health Sciences Centre

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00508859     History of Changes
Other Study ID Numbers: 0831997
Study First Received: July 26, 2007
Last Updated: July 27, 2007
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
depression
adolescents
maintenance treatment
antidepressant

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014