Therapy for Depression With Co-Occurring Panic or Anxiety Symptoms

This study has been completed.

Sponsor:

Information provided by:

National Institute of Mental Health (NIMH)

ClinicalTrials.gov Identifier:

NCT00051207

First received: January 7, 2003

Last updated: December 12, 2007

Last verified: December 2007

History of Changes

Tracking Information
First Received Date ^ICMJE	January 7, 2003
Last Updated Date	December 12, 2007
Start Date ^ICMJE	November 2002
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00051207 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Therapy for Depression With Co-Occurring Panic or Anxiety Symptoms
Official Title ^ICMJE	Interpersonal Psychotherapy for Depression With Co-Occurring Panic and Anxiety Symptoms (IPT-PS)
Brief 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.
Detailed 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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Depression Anxiety Disorders Panic Disorder
Intervention ^ICMJE	Behavioral: Interpersonal Psychotherapy (IPT) Behavioral: IPT for Depression with Co-occurring Panic and Anxiety Symptoms (IPT-PS)
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	36
Completion Date	August 2005
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00051207
Other Study ID Numbers ^ICMJE	R21 MH61948, DSIR AT-AS
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	National Institute of Mental Health (NIMH)
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	National Institute of Mental Health (NIMH)
Verification Date	December 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top