Status:
TERMINATED
Treatment for Chronic Depression
Lead Sponsor:
University of Chicago
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-58 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to test the clinical efficacy of two psychotherapies for early onset chronic major depression, including Behavioral Activation (Jacobson et al., 2001), and an integrated v...
Detailed Description
Early-onset unipolar major depression is linked with considerable morbidity and mortality (Birmaher et al., 1996). The goal of this project is to test the efficacy of Behavioral Activation (BA; Jacobs...
Eligibility Criteria
Inclusion
- depressed male and female subjects between ages 18 to 58 years.
- current and primary diagnosis of DSM-IV Major Depressive Disorder (e.g., no lifetime history of bipolar I or II disorder, current anxiety disorders, or current substance dependence disorder (American Psychiatric Association, 1994).
- should also have upon study entry a score of 14 or higher (moderate depression) on the Hamilton Rating Scale for Depression (HRSD; Hamilton, 1960) and a score of 20 or higher (moderate depression) on the Beck Depression Inventory II (BDI-II; Beck et al., 1996a).
- background of high childhood trauma (70-item Childhood Trauma Questionnaire with a Total Score of 9 or higher).
- reasonably fluent in English to complete the evaluation.
Exclusion
- history of bipolar affective disorder,
- history of psychosis (including schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, or psychotic organic brain syndrome)
- current non-psychotic Axis I disorder if it constitutes the predominant aspect of the clinical presentation and if it requires treatment other than that offered in the project (including anxiety disorders, somatoform disorders, dissociative disorders, or eating disorders, etc.),
- history of substance dependence in the past six months,
- antisocial, borderline, or schizotypal personality disorder,
- evidence of any medical disorder or condition that could cause depression or preclude the use of study treatments,
- current treatment with catecholaminergic antihypertensive medication, including reserpine, beta-blockers, clonidine, alphamethyldopa, etc. (diuretics, ACE inhibitors and calcium channel inhibitors will be allowed),
- clear indication of secondary gain (e.g., court ordered treatment or compensation issues),
- current suicide risk sufficient to preclude treatment on an outpatient basis (any patient scoring 3 or above on the suicide item on the HRSD or BDI must be cleared for study participation by the PI).
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
June 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00204152
Start Date
June 1 2004
End Date
June 1 2006
Last Update
September 5 2013
Active Locations (1)
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1
The University of Chicago, Department of Psychiatry
Chicago, Illinois, United States, 60637