NCT00227955

Brief Summary

This study will evaluate the effectiveness of five combinations of drug therapy and psychotherapy in maintaining remission of depression symptoms in people with recurrent major depression.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_4 depression

Timeline
Completed

Started Dec 1987

Longer than P75 for phase_4 depression

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1987

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1993

Completed
11.8 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2005

Completed
Last Updated

June 25, 2013

Status Verified

June 1, 2013

First QC Date

September 26, 2005

Last Update Submit

June 21, 2013

Conditions

Depression

Keywords

Major depression

Outcome Measures

Primary Outcomes (1)

  • Time to recurrence of depression symptoms

Secondary Outcomes (1)

  • Measured at Months 7, 11, and 36: Score on the Raskin Depression and Mania Severity Scales

Interventions

ImipramineDRUG
Interpersonal PsychotherapyBEHAVIORAL

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of recurrent major depression

You may not qualify if:

  • Unstable medical illness
  • Any other simultaneous psychiatric or medical illness of greater concern than depression (index episode of depression is not primary)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Psychiatric Institute and Cinic

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

DepressionDepressive Disorder, Major

Interventions

ImipramineInterpersonal Psychotherapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Ellen Frank, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 26, 2005

First Posted

September 28, 2005

Study Start

December 1, 1987

Study Completion

December 1, 1993

Last Updated

June 25, 2013

Record last verified: 2013-06

Locations

US(1)