Interpersonal Psychotherapy for Severely Depressed Inpatients

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

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.

Study Overview

• Status: Terminated
• Conditions: Major Depression
• Intervention / Treatment: Behavioral: Interpersonal Psychotherapy; Drug: sertraline or amitriptyline

Detailed 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Freiburg, Germany, 79104
    • University Clinic Freiburg , Dept. of Psychiatry and Psychotherapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The 17-item version of the Hamilton Rating Scale for Depression (HAMD) served as the primary outcome measure

Secondary Outcome Measures

Outcome Measure
Beck Depression Inventory

Collaborators and Investigators

• Sponsor: German Research Foundation
• Investigators: Study Director: Mathias Berger, MD, University Clinic Freiburg, Dept. of Psychiatry and Psychotherapy

Study record dates

Study Major Dates

• Study Start: November 1, 2000
• Study Completion: August 1, 2004

Study Registration Dates

• First Submitted: May 9, 2006
• First Submitted That Met QC Criteria: May 9, 2006
• First Posted (Estimate): May 11, 2006

Study Record Updates

• Last Update Posted (Estimate): December 20, 2006
• Last Update Submitted That Met QC Criteria: December 19, 2006
• Last Verified: October 1, 2000

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Tricyclic; Adrenergic Uptake Inhibitors; Sertraline; Amitriptyline
• Other Study ID Numbers: SCHR443/4-1; SCHR443/4-2