Status:
TERMINATED
Feasibility Study of Duloxetine in the Treatment of Depression in Patients With Traumatic Brain Injury
Lead Sponsor:
Rehabilitation Hospital of Indiana
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Traumatic Brain Injury
Depression
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 t...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 1996
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01223001
Start Date
September 1 1996
End Date
July 1 2011
Last Update
December 17 2014
Active Locations (1)
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1
Rehabilitation Hospital of Indiana
Indianapolis, Indiana, United States, 46254