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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00051207
Other study ID # R21MH061948
Secondary ID DSIR AT-AS
Status Completed
Phase Phase 1/Phase 2
First received January 7, 2003
Last updated June 21, 2013
Start date November 2002
Est. completion date August 2005

Study information

Verified date December 2007
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This 6-month study, with a 3-month follow up period, will compare the effectiveness of new and traditional psychotherapies for depression with panic or anxiety symptoms.


Description:

Many depressed patients also experience significant symptoms of panic or anxiety. This study will compare the effectiveness of a new therapy called interpersonal psychotherapy for depression with panic or anxiety symptoms (IPT-PS) with that of traditional interpersonal psychotherapy for depression (IPT).

Participants are randomly assigned to receive up to 24 weeks of treatment with either IPT-PS or traditional IPT. Improvements in interpersonal functioning, quality of life, and symptoms of depression and anxiety will be assessed at the end of therapy and at a 3-month follow-up.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date August 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- DSM-IV diagnosis of major depression with co-existing panic or anxiety symptoms.

Exclusion Criteria:

- History of manic episode(s). Patients who have had hypomanic episodes in the past will be accepted into the study, provided they meet other admission criteria and are not presenting in a current hypomanic or mixed episode.

- History of schizophrenia or schizoaffective disorder.

- Organic affective syndrome.

- Unspecified functional psychosis.

- Anorexia nervosa or bulimia nervosa. Patients meeting criteria for an eating disorder not otherwise specified will not be excluded.

- Chronic drug or alcohol abuse/dependence within the past 2 years. Patients with abuse related to episodes will not be excluded.

- DSM-IV criteria for borderline or antisocial personality disorder. Patients who meet criteria for other Axis II disorders will not be excluded.

- Inpatient treatment due to suicide risk or psychotic symptoms.

- Index episode secondary to the effect of medically prescribed drugs.

- Significant or untreated medical illness, including cardiovascular disorder, renal or liver disease, epilepsy, untreated hypertension, or unstabilized endocrine disease.

- Medical illness that would interfere with the best treatment strategy for the potential participant.

- Current treatment with an antidepressant. Patients on a stable dose of anxiolytics for at least 3 months prior to study participation who are able to maintain this dosage throughout the study will not be excluded.

- Pregnant and breast-feeding women will be accepted into the study, but will not be prescribed adjunctive medications.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
Interpersonal Psychotherapy (IPT)

IPT for Depression with Co-occurring Panic and Anxiety Symptoms (IPT-PS)


Locations

Country Name City State
United States Western Psychiatric Institute and Clinic - Depression and Manic Depression Program Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

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