Treatment of Post-TBI Depression
Information source: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression
Intervention: Sertraline (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Icahn School of Medicine at Mount Sinai Official(s) and/or principal investigator(s): Wayne Gordon, Ph.D., Principal Investigator, Affiliation: Icahn School of Medicine at Mount Sinai
Summary
Randomized clinical trial of sertraline vs. placebo for post-TBI depression
Clinical Details
Official title: Treatment of Post-TBI Depression
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Depression
Secondary outcome: BAILife-3
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. 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 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
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Criteria for inclusion in the study are: 1) 18 years or older; 2) experienced a TBI with a
documented loss of consciousness or other evidence of a TBI (i. e., evidence of pathology
on neuro-imaging); 3) at least 6 months post-injury; 4) English-speaking; 5) residential
telephone service; 6) living within 1. 5 hours of NYC; 6) able to comprehend or answer
verbal or written questionnaires; 7) willing to provide consent to participate in a 12
week drug study to treat MDD; current MDD as diagnosed using SCID, and severity of MDD
rated at least 18 on the HAM-D.
Exclusion Criteria:
1. currently taking antidepressant medication (including monamine oxidase inhibitors
(MOAs) or tricyclic antidepressants (TCAs) 2) unwilling to abstain from seeking new
psychosocial or pharmacologic treatments during the course of the study; 3) currently
in psychotherapy, 4) active suicidal plans and/or requiring hospitalization, 5) prior
use of sertraline, 6) currently experiencing other serious medical illness; 7)
currently pregnant or breast feeding; 8) mass brain lesions or other neurological
diagnoses other than TBI; 9) history of current or past psychosis or mania; 10)
current substance abuse; and 11) history of clinically significant liver or renal
disease.
Locations and Contacts
Mount Sinai School of Medicine, New York, New York 10029, United States
Additional Information
Starting date: June 2003
Last updated: March 7, 2012
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