Back to resultsInterpersonal Psychotherapy for Severely Depressed Inpatients
Primary Purpose
Major Depression
Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Interpersonal Psychotherapy
sertraline or amitriptyline
Sponsored by
About this trial
This is an interventional treatment trial for Major Depression
Eligibility 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
Sites / Locations
- University Clinic Freiburg , Dept. of Psychiatry and Psychotherapy
Outcomes
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
Full Information
NCT ID
NCT00325000
First Posted
May 9, 2006
Last Updated
December 19, 2006
Sponsor
German Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00325000
Brief Title
Interpersonal Psychotherapy for Severely Depressed Inpatients
Official Title
An Intensive Treatment Program of Interpersonal Psychotherapy Plus Pharmacotherapy for Severely Depressed Inpatients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2000
Overall Recruitment Status
Terminated
Study Start Date
November 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
German Research Foundation
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Psychotherapy
Intervention Type
Drug
Intervention Name(s)
sertraline or amitriptyline
Primary Outcome Measure Information:
Title
The 17-item version of the Hamilton Rating Scale for Depression (HAMD) served as the primary outcome measure
Secondary Outcome Measure Information:
Title
Beck Depression Inventory
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathias Berger, MD
Organizational Affiliation
University Clinic Freiburg, Dept. of Psychiatry and Psychotherapy
Official's Role
Study Director
Facility Information:
Facility Name
University Clinic Freiburg , Dept. of Psychiatry and Psychotherapy
City
Freiburg
ZIP/Postal Code
79104
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Interpersonal Psychotherapy for Severely Depressed Inpatients
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