Interpersonal Psychotherapy for Severely Depressed Inpatients

This study has been terminated.
Sponsor:
Information provided by:
German Research Foundation
ClinicalTrials.gov Identifier:
NCT00325000
First received: May 9, 2006
Last updated: December 19, 2006
Last verified: October 2000
  Purpose

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.


Condition Intervention
Major Depression
Behavioral: Interpersonal Psychotherapy
Drug: sertraline or amitriptyline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Intensive Treatment Program of Interpersonal Psychotherapy Plus Pharmacotherapy for Severely Depressed Inpatients

Resource links provided by NLM:


Further study details as provided by German Research Foundation:

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

Secondary Outcome Measures:
  • Beck Depression Inventory

Study Start Date: November 2000
Estimated Study Completion Date: August 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00325000

Locations
Germany
University Clinic Freiburg , Dept. of Psychiatry and Psychotherapy
Freiburg, Germany, 79104
Sponsors and Collaborators
German Research Foundation
Investigators
Study Director: Mathias Berger, MD University Clinic Freiburg, Dept. of Psychiatry and Psychotherapy
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00325000     History of Changes
Other Study ID Numbers: SCHR443/4-1, SCHR443/4-2
Study First Received: May 9, 2006
Last Updated: December 19, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Amitriptyline
Sertraline
Amitriptyline, perphenazine drug combination
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Serotonin Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on April 22, 2014