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| Sponsor: | University of Iowa |
|---|---|
| Collaborator: |
National Institute of Neurological Disorders and Stroke (NINDS) |
| Information provided by: | University of Iowa |
| ClinicalTrials.gov Identifier: | NCT00704379 |
Purpose
The purpose of this study is to examine the efficacy of sertraline to prevent the onset of mood and anxiety disorders during the first six months after traumatic brain injury.
| Condition | Intervention | Phase |
|---|---|---|
|
Traumatic Brain Injury |
Drug: Placebo Drug: Sertraline |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Official Title: | Treatment Strategy to Prevent Mood Disorders Following Traumatic Brain Injury |
| Estimated Enrollment: | 104 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Placebo Comparator
Placebo will be given in a double blind fashion via an equal number of tablets (identical to the sertraline tablets) administered once daily.
|
Drug: Placebo
an inactive substance
|
|
B: Experimental
Sertraline will be given in a double blind fashion via tablets administered once daily. Once stabilized in the targeted dosage (100 mg per day), sertraline serum levels will be monitored twice during the course of the intervention.
|
Drug: Sertraline
Sertraline and placebo will be given in a double blind fashion via an equal number of identical tablets administered once daily. Once stabilized in the targeted dosage (100 mg per day), sertraline serum levels will be monitored twice during the course of the intervention. Blood samples will be obtained randomly, one during the first and one during the second trimesters of the protocol.
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Traumatic brain injury (TBI) is a leading cause of death and disability among young adults. Mood disorders are the most frequent psychiatric complication of TBI, and have a large impact on family functioning, interpersonal relationships, and ability to return to work or school. Furthermore, a significant proportion of these disorders will progress to more chronic and treatment refractory forms. In spite of their clinical relevance, mood and anxiety disorders remain largely unrecognized and not adequately treated, contributing to greater disability and decreased participation in the aftermath of TBI.
The goals of this study are to learn more about how people recover from brain injury and to evaluate the effect of sertraline (also known as Zoloft) compared to placebo (an inactive substance) in preventing the occurrence of emotional and behavioral problems—such as depression, lack of motivation, anxiety, irritability or aggressive outbursts—following TBI.
In the study, a group of 104 participants with TBI—recruited immediately after resolution of posttraumatic amnesia—will be randomly assigned to receive six months of double-blind treatment with sertraline or placebo.
This study will determine how these emotional and behavioral problems influence thinking, physical recovery, and return to a productive life six months after brain injury. Researchers will also determine if certain brain changes can predict the occurrence of behavioral problems and if treatment with sertraline can prevent them. Additionally, the researchers will examine the effect of sertraline on frequent post-TBI behavioral disorders such as aggression, impulsivity, poor decision making and apathetic symptoms.
Magnetic resonance imaging (MRI)-based volumetry and diffusion tensor imaging will be used to examine the structural correlates of mood and anxiety disorders and to evaluate them as biological predictors of treatment response and community reintegration. The researchers hypothesize that early preventive treatment with sertraline will reduce mood and behavioral symptoms, prevent the occurrence of structural and functional brain changes associated with the onset of mood disorders, increase access to and participation in rehabilitation programs for TBI, and, consequently, improve psychosocial outcome.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Stephanie A. Rosazza, BA | 319-353-5807 | stephanie-rosazza@uiowa.edu |
| Contact: Robert Robinson | 319-356-1144 |
| United States, Iowa | |
| Department of Psychiatry, University of Iowa Hospitals and Clinics, 200 Hawkins Drive | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Jennifer L. Lassner 319-335-2134 Jennifer-lassner@uiowa.edu | |
| Principal Investigator: | Ricardo E. Jorge, MD | Department of Psychiatry, UI Hospitals and Clinics |
More Information
| Responsible Party: | University of Iowa Hospitals and Clinics Department of Psychiatry ( Ricardo Jorge, MD, Associate Professor ) |
| Study ID Numbers: | R01NS055827, 1 R01 NS055827-01A2 |
| Study First Received: | June 20, 2008 |
| Last Updated: | January 14, 2010 |
| ClinicalTrials.gov Identifier: | NCT00704379 History of Changes |
| Health Authority: | United States: Federal Government |
|
traumatic brain injury TBI mood disorders anxiety disorders community reintegration |
executive function sertraline diffusion tensor imaging DTI |
|
Craniocerebral Trauma Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Nervous System Diseases Wounds and Injuries Psychotropic Drugs Central Nervous System Diseases Disorders of Environmental Origin Trauma, Nervous System |
Brain Diseases Serotonin Uptake Inhibitors Pharmacologic Actions Serotonin Agents Mental Disorders Therapeutic Uses Mood Disorders Sertraline Brain Injuries Central Nervous System Agents Antidepressive Agents |
