CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 94 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Sertraline 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00704379
NCT00704379Phase 3Completed
CompareCT.gov

Treatment Strategy to Prevent Mood Disorders Following Traumatic Brain Injury

Baylor College of Medicine·interventional·Posted Jun 24, 2008·Updated Aug 25, 2015

In Brief

A Phase 3 clinical trial evaluating Placebo and Sertraline for Traumatic Brain Injury. Completed, enrolled 94 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTraumatic Brain Injury
CountriesUnited States
CollaboratorsNational Institute of Neurological Disorders and Stroke (NINDS)

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 24, 2008
Enrollment StartJun 1, 2008
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 18.0 years ago

Interventions

Placebodrug

an inactive substance

Sertralinedrug

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.