Treatment of Post-TBI Depression
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Randomized clinical trial of sertraline vs. placebo for post-TBI depression
| Condition | Intervention | Phase |
|---|---|---|
|
Depression |
Drug: Sertraline Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Treatment of Post-TBI Depression |
- Depression [ Time Frame: immediately post-intervention ] [ Designated as safety issue: No ]self-report of depression and DSM-IV diagnosis
- BAI [ Time Frame: Immediately post-intervention ] [ Designated as safety issue: No ]Anxiety
- Life-3 [ Time Frame: Immediately post-intervention ] [ Designated as safety issue: No ]Quality of life
| Enrollment: | 52 |
| Study Start Date: | June 2003 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sertraline
Sertraline
|
Drug: Sertraline
Sertraline arm
|
|
Placebo Comparator: Placebo
Placebo
|
Drug: Placebo
Placebo
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-
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:
- 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.
Contacts and Locations| United States, New York | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| Principal Investigator: | Wayne Gordon, Ph.D. | Mount Sinai School of Medicine |
More Information
No publications provided by Mount Sinai School of Medicine
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Mount Sinai School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00233103 History of Changes |
| Other Study ID Numbers: | GCO 02-0677, H133A020501 |
| Study First Received: | October 3, 2005 |
| Last Updated: | March 7, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mount Sinai School of Medicine:
|
Sertraline TBI depression SSRI brain injury |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Sertraline Antidepressive Agents Psychotropic Drugs Central Nervous System Agents |
Therapeutic Uses Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013