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Interpersonal Psychotherapy for Severely Depressed Inpatients

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00325000
First Posted: May 11, 2006
Last Update Posted: December 20, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
German Research Foundation
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Intensive Treatment Program of Interpersonal Psychotherapy Plus Pharmacotherapy for Severely Depressed Inpatients

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00325000     History of Changes
Other Study ID Numbers: SCHR443/4-1
SCHR443/4-2
First Submitted: May 9, 2006
First Posted: May 11, 2006
Last Update Posted: December 20, 2006
Last Verified: October 2000

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