Treatment of Post-Traumatic Brain Injury (TBI) Depression

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Randomized clinical trial of sertraline vs. placebo for post-TBI depression

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborator: U.S. Department of Education
• Treatments: Sertraline

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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