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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00325000 |
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Date of registration:
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09/05/2006 |
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Primary sponsor: |
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Public title:
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Interpersonal Psychotherapy for Severely Depressed Inpatients
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Scientific title:
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An Intensive Treatment Program of Interpersonal Psychotherapy Plus Pharmacotherapy for Severely Depressed Inpatients |
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Date of first enrolment:
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November 2000 |
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Target sample size:
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00325000 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Germany
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Contacts
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Name:
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Mathias Berger, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Clinic Freiburg, Dept. of Psychiatry and Psychotherapy |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Major Depression
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Intervention(s)
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Behavioral: Interpersonal Psychotherapy
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Drug: sertraline or amitriptyline
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Primary Outcome(s)
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The 17-item version of the Hamilton Rating Scale for Depression (HAMD) served as the primary outcome measure
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Secondary Outcome(s)
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Beck Depression Inventory
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Secondary ID(s)
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SCHR443/4-1
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SCHR443/4-2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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