NCT00249886

Brief Summary

The purpose of the study is to evaluate whether it is advantageous for adolescents who have recovered from depression after a 6 to 12 week course of antidepressant treatment to stay on the treatment a further 6 months or is it just as helpful to stop the medication after recovery. The hypothesis is that adolescents with major depression who recover from the 6 to 12 week trial of citalopram will be less likely to have a recurrence of depression over a 6 month period if continued on the citalopram as compared to those who discontinue the medication.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2002

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
withdrawn

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

September 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2005

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

September 19, 2006

Status Verified

November 1, 2005

First QC Date

November 3, 2005

Last Update Submit

September 18, 2006

Conditions

Major Depression

Outcome Measures

Primary Outcomes (1)

  • Relapse - subject meets criteria for an episode of major depression for 2 weeks or more.

Interventions

CitalopramDRUG

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of major Depression.
  • Age 13-18.
  • A score of \> 16 on the 17 item Hamilton Depression Scale or a score of \> 12 on the 17 items plus a score of \>7 on the atypical items.
  • Males and females.
  • Outpatient at initiation of double blind treatment phase.
  • Ability to give informed consent.

You may not qualify if:

  • Past or current hypomanic or manic episode.
  • Currently meets criteria for a Conduct Disorder.
  • Current psychotic symptoms.
  • Substance dependence in the last 3 months.
  • Significant medical condition that would contraindicate the use of an antidepressant.
  • Pregnancy
  • Past treatment with Citalopram for major depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Anthony J Levitt, MD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 3, 2005

First Posted

November 7, 2005

Study Start

September 1, 2002

Study Completion

November 1, 2006

Last Updated

September 19, 2006

Record last verified: 2005-11

Locations

CA(1)