Treatment of Depression in Adults

Phase 4

Completed

• Conditions: Depression
• Interventions: Behavioral: Interpersonal Psychotherapy; Other: Escitalopram plus IPT; Drug: Escitalopram

• Registration Number: NCT00073697
• Lead Sponsor: University of Pittsburgh

Brief Summary

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

Detailed Description

Major depression is a serious condition that can have devastating functional consequences. Although numerous depression studies have been conducted, understanding of how best to achieve long-term recovery remains limited. This study will assess the mood, personality, pharamcokinetic and genetic characteristics of depressed participants to determine the effects of these features on treatment response.

This study will be conducted at two international treatment sites, including the University of Pittsburgh and the University of Pisa, Italy. Participants will be randomly assigned to receive either interpersonal psychotherapy (IPT) or escitalopram pharmacotherapy for a minimum of 32 weeks or approximately 8 months. 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. Clinical evaluations and questionnaires will be used to assess participants.

Study Timeline

• Study Start: 2003-05
• Study First Submitted: 2003-12-02
• Study First Submitted QC: 2003-12-02
• Study First Posted: 2003-12-03
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-10
• Last Update Posted: 2012-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

• Diagnosis of Major depression

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Interpersonal Psychotherapy	Interpersonal Psychotherapy
3	Escitalopram plus IPT	Escitalopram plus IPT
2	Escitalopram	Escitalopram

Primary Outcome Measures

Name	Time	Method
Hamilton Rating Scale for Depression score	Measured at Months 8 and 14
Treatment-relevant phenotypes of depression	Measured at Months 8 and 14

Trial Locations

Locations (2)

Western Psychiatric Institute and Clinic - Depression Prevention Program; 🇺🇸 Pittsburgh, Pennsylvania, United States

The University of Pisa; 🇮🇹 Pisa, Italy