Treatment of Post-Traumatic Brain Injury (TBI) Depression

Completed · Phase 2 · Has a placebo group

Conditions studied: Depression

In brief

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

Key facts

Study ID

NCT00233103

Run by

Icahn School of Medicine at Mount Sinai

People needed

52

Starts

2003-06-01

Expected to finish

2008-09-01

Last updated by the study team

2015-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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