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| Sponsored by: |
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 |
| Study Start Date: | November 2000 |
| Estimated Study Completion Date: | August 2004 |
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 |
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| Germany | |
| University Clinic Freiburg , Dept. of Psychiatry and Psychotherapy | |
| Freiburg, Germany, 79104 | |
| Study Director: | Mathias Berger, MD | University Clinic Freiburg, Dept. of Psychiatry and Psychotherapy |
More Information
| 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 |
|
Neurotransmitter Agents Depression Adrenergic Agents Psychotropic Drugs Depressive Disorder, Major Depressive Disorder Behavioral Symptoms Antidepressive Agents, Tricyclic |
Mental Disorders Analgesics, Non-Narcotic Mood Disorders Amitriptyline Sertraline Peripheral Nervous System Agents Analgesics Antidepressive Agents |
|
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Depression Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic Uptake Inhibitors Physiological Effects of Drugs Psychotropic Drugs Depressive Disorder, Major Depressive Disorder Pharmacologic Actions Behavioral Symptoms |
Antidepressive Agents, Tricyclic Sensory System Agents Analgesics, Non-Narcotic Mental Disorders Therapeutic Uses Mood Disorders Amitriptyline Peripheral Nervous System Agents Analgesics Central Nervous System Agents Antidepressive Agents |
