NCT00073697

Brief Summary

This study will determine how certain features of depressed individuals affect their responses to depression treatment.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
290

participants targeted

Target at P75+ for phase_4 depression

Timeline
Completed

Started May 2003

Typical duration for phase_4 depression

Geographic Reach
2 countries

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

May 1, 2003

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2003

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

January 11, 2012

Status Verified

January 1, 2012

Enrollment Period

4.4 years

First QC Date

December 2, 2003

Last Update Submit

January 10, 2012

Conditions

Depression

Keywords

PsychotherapyDepressive disorderAntidepressive agentsCitalopram

Outcome Measures

Primary Outcomes (2)

  • Hamilton Rating Scale for Depression score

    Measured at Months 8 and 14

  • Treatment-relevant phenotypes of depression

    Measured at Months 8 and 14

Study Arms (3)

1

EXPERIMENTAL

Interpersonal Psychotherapy

Behavioral: Interpersonal Psychotherapy

2

EXPERIMENTAL

Escitalopram

Drug: Escitalopram

3

EXPERIMENTAL

Escitalopram plus IPT

Other: Escitalopram plus IPT

Interventions

EscitalopramDRUG

Participants will receive escitalopram for a minimum of 32 weeks or approximately 8 months. Participants whose symptoms become stabilized will continue the initial treatment for another 6 months.

2
Interpersonal PsychotherapyBEHAVIORAL

Participants will receive interpersonal psychotherapy (IPT) for 8 months and possibly an additional 6 months.

1
Escitalopram plus IPTOTHER

Participants whose symptoms become stabilized will continue the initial treatment for another 6 months. Those who do not will have the second treatment added to their regimen until remission occurs.

3

Eligibility Criteria

Age18 Years - 66 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Major depression

You may not qualify if:

  • History of manic or hypomanic episodes
  • History of schizophrenia or schizoaffective disorder
  • Diagnosis of anorexia nervosa or bulimia nervosa
  • Current psychosis
  • Drug and/or alcohol dependence or abuse within 3 months prior to study entry. Participants with episodic abuse related to mood disorders will not be excluded.
  • Diagnosis of antisocial personality disorder
  • Diagnosis of organic affective syndrome and uncontrolled medical illness
  • Pregnancy
  • Require inpatient treatment for suicidal risk or psychosis
  • History of an inability to tolerate any of the study treatments
  • Currently receiving treatment with an effective antidepressant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Western Psychiatric Institute and Clinic - Depression Prevention Program

Pittsburgh, Pennsylvania, 15213, United States

Location

The University of Pisa

Pisa, Italy

Location

MeSH Terms

Conditions

DepressionDepressive Disorder

Interventions

EscitalopramInterpersonal Psychotherapyadenylate isopentenyltransferase

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Ellen Frank

    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

December 2, 2003

First Posted

December 3, 2003

Study Start

May 1, 2003

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

January 11, 2012

Record last verified: 2012-01

Locations

US(1)IT(1)