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

• Status: Terminated
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rehabilitation Hospital of Indiana
• Collaborator: Eli Lilly and Company
• Treatments: Duloxetine Hydrochloride

Criteria

Inclusion Criteria:

• Study participants will be 40 men and women between the ages of 18 and 75 who provide appropriate consent and who are agreeable to study requirements

• Diagnosed with mild to moderate traumatic brain injury as defined by an initial Mayo Traumatic Brain Injury Severity Scale

• Have memory impairments defined by a Hopkins Verbal Learning Test delayed recall score which falls less than or equal to 1.5 standard deviation below the mean.

Exclusion Criteria:

• Refusal to give informed consent

• A previous Central Nervous System illness or injury, including seizure that exhibits residual symptoms.

• Current post-traumatic seizure disorder

• A previous diagnosis of a psychotic disorder

• Current or previous (in the last 6 months) treatment history for alcohol or substance dependency

• Medications affecting noradrenergic or dopaminergic systems, alpha-adrenergic antihypertensives, antidepressant, phenobarbital, Monoamine oxidase inhibitor (MAOI), scheduled benzodiazepines, psychoactive herbal supplements (including Kava, St. John's wort), or nutritional supplements or within at least 14 days of discontinuing treatment with the above medications or supplements.

• A known suicide risk

• A pregnant or breastfeeding woman

• Uncontrolled narrow-angle glaucoma

• Serious and/or unstable medical comorbidity (e.g., AIDS, cancer, history of uncontrolled hypertension or cardiovascular disease) psychological condition, or clinically significant laboratory abnormality that in the opinion of the investigator would compromise participation in the study or be likely to lead to hospitalization during the course of the study

• Liver enzymes > 1.5 times upper limit of normal

• Patients with end-stage renal disease (requiring dialysis) or severe renal impairment

• Known hypersensitivity to duloxetine or any of the inactive ingredients