NCT01223001

Feasibility Study of Duloxetine in the Treatment of Depression in Patients With Traumatic Brain Injury

Prevention of Depression and Enhancement of Cognitive Recovery Following Traumatic Brain Injury With Duloxetine

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Rehabilitation Hospital of Indiana · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to compare the efficacy of duloxetine 60 mg by mouth daily with placebo in the prevention of depression associated with mild/moderate traumatic brain injury and to enhance cognitive function.

Detailed description

The primary objective of the study is to compare the efficacy of duloxetine 60 mg by mouth daily with placebo in the prevention of depression associated with mild/moderate traumatic brain injury and to enhance cognitive function. Research exploring the use of selective serotonin reuptake inhibitors in the treatment of post-traumatic depression generally validates this approach (Horsfield et al., 2002). However, the literature suggests that serotonin/norepinephrine reuptake inhibitors such as duloxetine may be more effective in the treatment of depression.

Conditions

• Traumatic Brain Injury
• Depression

Interventions

Type	Name	Description
DRUG	Duloxetine	Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
DRUG	Sugar pill	Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.

Timeline

• Start date: 1996-09-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2010-10-18
• Last updated: 2014-12-17
• Results posted: 2014-12-17

Locations

1 site across 1 country: United States