Treatment of Depression in Adults

Depression Clinical Trial

Official title:

Depression: The Search for Treatment-Relevant Phenotypes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00073697
• Other study ID #: R01MH065376
• Secondary ID: R01MH065376DSIR
• Status: Completed
• Phase: Phase 4
• First received: December 2, 2003
• Last updated: January 10, 2012
• Start date: May 2003
• Est. completion date: October 2007

Study information

• Verified date: January 2012
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 66 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Escitalopram
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.

Behavioral:
• Interpersonal Psychotherapy
Participants will receive interpersonal psychotherapy (IPT) for 8 months and possibly an additional 6 months.

Other:
• Escitalopram plus IPT
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.

Locations

Country	Name	City	State
Italy	The University of Pisa	Pisa
United States	Western Psychiatric Institute and Clinic - Depression Prevention Program	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Mental Health (NIMH)

Countries where clinical trial is conducted

United States,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Rating Scale for Depression score		Measured at Months 8 and 14	No
Primary	Treatment-relevant phenotypes of depression		Measured at Months 8 and 14	No