Treatment of Post-Traumatic Brain Injury (TBI) Depression

Mount Sinai Health System

Status and phase

Completed

Phase 2

Conditions

Depression

Treatments

Drug: Placebo

Drug: Sertraline

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT00233103

GCO 02-0677

H133A020501

Details and patient eligibility

About

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

Full 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. Researchers will also explore the effects of sertraline on anxiety disorders, which often accompany post-TBI depression.

Background: Major depression is experienced by many more people after TBI than prior to injury and more often than in people without a brain injury. Many studies have also shown that this higher than 'normal' incidence looms for many years post TBI. Major depression is associated with a variety of negative outcomes, including poorer functioning in basic activities, reduced employment, elevated divorce rate, reduced social and recreational activity and increased sexual dysfunction.

Need for Research: Of the current drug treatments for major depression, sertraline and similar drugs (known as selective serotonin reuptake inhibitors, or selective serotonin reuptake inhibitor (SSRIs)) have few side effects in people who have experienced a brain injury and have been shown to be effective in people with no known brain injury. However, information on the impact of SSRIs on post-TBI depression, based on randomized, double-blind studies, is unavailable.

Current Research Activity: Approximately 50 men and women volunteers who are post TBI and currently diagnosed with major depressive disorder are being randomly assigned to a 12-week period of taking Zoloft or a placebo. Over the period of study, participants will have the severity of their depressive symptoms assessed (as well as their symptoms of anxiety); a simple measure of the volunteer's perceived quality of life will be implemented prior to the study and at its termination. It is hypothesized that sertraline will reduce the symptoms of depression and anxiety and will increase the person's perceived quality of life to a significantly greater extent than will the placebo.

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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