Interpersonal Psychotherapy for Severely Depressed Inpatients

Major Depression Clinical Trial

Official title:

An Intensive Treatment Program of Interpersonal Psychotherapy Plus Pharmacotherapy for Severely Depressed Inpatients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00325000
• Other study ID #: SCHR443/4-1
• Secondary ID: SCHR443/4-2
• Status: Terminated
• Phase: N/A
• First received: May 9, 2006
• Last updated: December 19, 2006
• Start date: November 2000
• Est. completion date: August 2004

Study information

• Verified date: October 2000
• Source: German Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

We examined the hypotheses that severely depressed inpatients treated for 5 weeks with IPT-S plus pharmacotherapy have 1) a higher reduction in depressive symptoms and 2) higher response- and remission rates compared to pharmacotherapy plus CM. For the follow-up period (12 months) we hypothesized a better symptomatic and psychosocial longterm outcome and lower rates of relapse for patients initially treated with combination therapy.

Description:

A randomized controlled trial was conducted in 124 hospitalized patients with a DSM IV diagnosis of Major Depressive Disorder comparing 5 weeks of Interpersonal Psychotherapy modified for depressed inpatients (IPT-S) plus pharmacotherapy versus medication plus intensive Clinical Management (CM). The study included a prospective, naturalistic follow-up 3- and 12 months after acute treatment in 97 of 105 treatment completers. The 17-item version of the Hamilton Rating Scale for Depression (HAMD) served as the primary outcome measure.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

Major Depression (single episode, recurrent or bipolar II) according to the Structured Clinical Interview for DSM IV (SCID)and a score of = 16 on the 17-item version of the Hamilton Rating Scale for Depression (HAMD)

Exclusion Criteria:

(1) concurrent diagnosis of bipolar I disorder, primary substance abuse or dependency, mental disorder due to organic factors, and borderline or antisocial personality disorder, (2) psychotic symptoms, (3) severe cognitive impairment, (4) contraindications to the study medication, and (5) being actively suicidal

Study Design

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

Related Conditions & MeSH terms

• Depressive Disorder, Major
• Major Depression

Intervention

Behavioral:
• Interpersonal Psychotherapy

Drug:
• sertraline or amitriptyline

Locations

Country	Name	City	State
Germany	University Clinic Freiburg , Dept. of Psychiatry and Psychotherapy	Freiburg

Sponsors (1)

Lead Sponsor	Collaborator
German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The 17-item version of the Hamilton Rating Scale for Depression (HAMD) served as the primary outcome measure
Secondary	Beck Depression Inventory