Interpersonal Psychotherapy for Severely Depressed Inpatients - Full Text View

Sponsor:	German Research Foundation
Information provided by:	German Research Foundation
ClinicalTrials.gov Identifier:	NCT00325000

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:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	An Intensive Treatment Program of Interpersonal Psychotherapy Plus Pharmacotherapy for Severely Depressed Inpatients

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Amitriptyline Sertraline hydrochloride Sertraline Amitriptyline hydrochloride Triavil

U.S. FDA Resources

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

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

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder, Major
Mental Disorders
Sensory System Agents
Therapeutic Uses
Sertraline
Analgesics

Antidepressive Agents
Depression
Depressive Disorder
Serotonin Uptake Inhibitors
Pharmacologic Actions
Antidepressive Agents, Tricyclic
Behavioral Symptoms
Serotonin Agents
Analgesics, Non-Narcotic
Amitriptyline
Mood Disorders
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010