Treatment of Depression in Adults | NCT00073697

Studies
Treatment of Depression in Adults

NCT00073697

Sponsor

University of Pittsburgh

Status

Completed

Last Update Posted

Jan 11, 2012Estimated

Enrollment

290Actual

Phase

Phase 4

Conditions

Depression

Interventions

Escitalopram
Interpersonal Psychotherapy
Escitalopram plus IPT

Countries

United States
Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01MH065376	U.S. NIH Grant/Contract		View source
DSIR 83-ATAS

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2003

Primary Completion Date

Oct 2007Actual

Completion Date

Oct 2007Actual

First Submitted Date

Dec 2, 2003

First Submission Date that Met QC Criteria

Dec 2, 2003

First Posted Date

Dec 3, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2012

Last Update Posted Date

Jan 11, 2012Estimated

Name	Class
National Institute of Mental Health (NIMH)	NIH

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

290Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Interpersonal Psychotherapy	Behavioral: Interpersonal Psychotherapy
2	Experimental	Escitalopram	Drug: Escitalopram
3	Experimental	Escitalopram plus IPT	Other: Escitalopram plus IPT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Escitalopram	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hamilton Rating Scale for Depression score		Measured at Months 8 and 14
Treatment-relevant phenotypes of depression		Measured at Months 8 and 14

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

66 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ellen Frank	University of Pittsburgh	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Western Psychiatric Institute and Clinic - Depression Prevention Program		Pittsburgh	Pennsylvania	15213	United States

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D003866	Depressive Disorder

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D019964	Mood Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000089983	Escitalopram
D000079062	Interpersonal Psychotherapy
C024274	adenylate isopentenyltransferase

Ancestor Terms

ID	Term
D011437	Propylamines
D000588	Amines
D009930	Organic Chemicals
D009570	Nitriles
D001572

Browse Leaves

Not provided

Browse Branches

Not provided