NCT00508859

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for phase_4 depression

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1997

Completed
10.1 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2007

Completed
Last Updated

July 30, 2007

Status Verified

July 1, 2007

First QC Date

July 26, 2007

Last Update Submit

July 27, 2007

Conditions

Depression

Keywords

depressionadolescentsmaintenance treatmentantidepressant

Outcome Measures

Primary Outcomes (1)

  • recurrence of depression

    52 weeks

Study Arms (2)

Active, 1

EXPERIMENTAL

sertraline

Drug: Sertraline

Placebo

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

SertralineDRUG

maintenance treatment with sertraline

Also known as: zoloft
Active, 1
placeboDRUG

placebo

Placebo

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 13-19
  • Diagnosis of Major Depression

You may not qualify if:

  • History of mania/hypomania
  • Current psychotic symptoms
  • Substance dependence
  • Medical conditions (contraindication for sertraline)
  • Pregnancy
  • Past treatment with sertraline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UBC

Vancouver, British Columbia, Canada

Location

Dalhousie University

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Related Publications (1)

  • Cheung A, Kusumakar V, Kutcher S, Dubo E, Garland J, Weiss M, Kiss A, Levitt A. Maintenance study for adolescent depression. J Child Adolesc Psychopharmacol. 2008 Aug;18(4):389-94. doi: 10.1089/cap.2008.0001.

    PMID: 18759650DERIVED

MeSH Terms

Conditions

Depression

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Anthony Levitt, MD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 26, 2007

First Posted

July 30, 2007

Study Start

July 1, 1997

Last Updated

July 30, 2007

Record last verified: 2007-07

Locations

CA(2)