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Treatment of Depression in Adults

Primary Purpose

Depression

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Escitalopram
Interpersonal Psychotherapy
Escitalopram plus IPT
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Psychotherapy, Depressive disorder, Antidepressive agents, Citalopram

Eligibility Criteria

18 Years - 66 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Western Psychiatric Institute and Clinic - Depression Prevention Program
  • The University of Pisa

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Interpersonal Psychotherapy

Escitalopram

Escitalopram plus IPT

Outcomes

Primary Outcome Measures

Hamilton Rating Scale for Depression score
Treatment-relevant phenotypes of depression

Secondary Outcome Measures

Full Information

First Posted
December 2, 2003
Last Updated
January 10, 2012
Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00073697
Brief Title
Treatment of Depression in Adults
Official Title
Depression: The Search for Treatment-Relevant Phenotypes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Psychotherapy, Depressive disorder, Antidepressive agents, Citalopram

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
290 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Interpersonal Psychotherapy
Arm Title
2
Arm Type
Experimental
Arm Description
Escitalopram
Arm Title
3
Arm Type
Experimental
Arm Description
Escitalopram plus IPT
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Psychotherapy
Intervention Description
Participants will receive interpersonal psychotherapy (IPT) for 8 months and possibly an additional 6 months.
Intervention Type
Other
Intervention Name(s)
Escitalopram plus IPT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hamilton Rating Scale for Depression score
Time Frame
Measured at Months 8 and 14
Title
Treatment-relevant phenotypes of depression
Time Frame
Measured at Months 8 and 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Frank
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Psychiatric Institute and Clinic - Depression Prevention Program
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
The University of Pisa
City
Pisa
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Treatment of Depression in Adults

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