Status:
COMPLETED
Treatment of Post-Traumatic Brain Injury (TBI) Depression
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
U.S. Department of Education
Conditions:
Depression
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Randomized clinical trial of sertraline vs. placebo for post-TBI depression
Detailed Description
Purpose: The purpose of this study is to document the efficacy of sertraline (Zoloft) in the treatment of depression (major depressive disorder) after TBI, including the impact on quality of life. Res...
Eligibility Criteria
Inclusion
- 18 years or older
- experienced a TBI with a documented loss of consciousness or other evidence of a TBI (i.e., evidence of pathology on neuro-imaging)
- at least 6 months post-injury
- English-speaking
- residential telephone service
- living within 1.5 hours of New York City
- able to comprehend or answer verbal or written questionnaires
- willing to provide consent to participate in a 12 week drug study to treat Major Depressive Disorder (MDD); current MDD as diagnosed using Structured Clinical Interview for Diagnostic and Statistical Manual Diploma in Social Medicine (DSM) Disorders (SCID), and severity of MDD rated at least 18 on the HAM-D.
Exclusion
- currently taking antidepressant medication (including monamine oxidase inhibitors (MOAs) or tricyclic antidepressants (TCAs)
- unwilling to abstain from seeking new psychosocial or pharmacologic treatments during the course of the study
- currently in psychotherapy
- active suicidal plans and/or requiring hospitalization
- prior use of sertraline
- currently experiencing other serious medical illness
- currently pregnant or breast feeding
- mass brain lesions or other neurological diagnoses other than TBI
- history of current or past psychosis or mania
- current substance abuse
- history of clinically significant liver or renal disease
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00233103
Start Date
June 1 2003
End Date
September 1 2008
Last Update
November 13 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029