Phase 3
Completed N=94
Treatment Strategy to Prevent Mood Disorders Following Traumatic Brain Injury
Source: ClinicalTrials.gov NCT00704379 ↗Enrolled (actual)
94
Serious AEs
2.1%
Results posted
May 2015
Primary outcomePrimary: Time to Onset of Diagnostic and Statistical Manual (DSM) IV Defined Mood and Anxiety Disorders Associated With Traumatic Brain Injury (TBI) — 21.4264; 15.7833 weeks — p=<0.05
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Onset of Diagnostic and Statistical Manual (DSM) IV Defined Mood and Anxiety Disorders Associated With Traumatic Brain Injury (TBI) |
21.4264; 15.7833 | <0.05 sig |
| SECONDARY Total Community Integration Questionnaire Scores |
16.77; 17.67 | — |
| SECONDARY Iowa Gambling Task Score |
16.67; -0.77 | — |
| SECONDARY Memory Function Composite |
-0.08; 0.07 | — |
| SECONDARY Social Functioning Examination Total Score |
0.04; 0.04 | — |
| SECONDARY Neuroimaging Variables (i.e., Fractional Anisotropy [FA] of Frontal White Matter Such as the Cingulate Gyrus) |
0.91; 0.94 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 years or over.
- Meeting the Center for Disease Control (CDC) criteria for TBI.
- Mild, Moderate, or Severe TBI as categorized by initial Glasgow Coma Scale (GCS) scores 13 to 15, 9 to 12, or 3 to 8, respectively.
- Complete recovery from Post Traumatic Amnesia (PTA) within 4 weeks of the traumatic episode.
Exclusion Criteria
- Penetrating head injuries.
- Clinical or neuro-radiological evidence of associate spinal cord injury.
- Patients with severe comprehension deficits (i.e., those who are not able to complete part II of the Token Test) that precludes a thorough neuropsychiatric evaluation.
- Presence of Diagnostic and Statistical Manual IV defined mood, anxiety or psychotic disorder at the time of enrollment to the study. However, patients with a history of alcohol abuse or alcohol dependence during the year preceding TBI will be included in the study.
- Patients who were taking antidepressants at the time of TBI or during a six month period prior to the traumatic event.
- Patients who have failed an adequate previous trial with sertraline or had side effects that prompted the discontinuation of this medication.
- Pregnant women or women that plan to become pregnant during the period of the study.
- Severe complicating illness such as neoplastic disease or uncompensated heart, renal or liver failure.
Data sourced from ClinicalTrials.gov (NCT00704379). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.