Feasibility Study of Duloxetine in the Treatment of Depression in Patients With Traumatic Brain Injury
Condition: Traumatic Brain Injury; Depression
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries; Depression; Depressive Disorder
Intervention: Duloxetine; Sugar pill
Intervention description: 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.; 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.
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Depression; Traumatic brain injury; Duloxetine; Cymbalta; impaired cognitive function

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.
    

Eligibility 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