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

NCT ID: NCT01223001

Last Updated: 2014-12-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-09-30
• Study Completion Date: 2011-07-31

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 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

Keywords

Traumatic brain injury; Duloxetine; Cymbalta; impaired cognitive function; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Duloxetine

Intervention Type: DRUG

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 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.

Group Type: PLACEBO_COMPARATOR

Sugar pill

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Cymbalta; Lactose

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Rehabilitation Hospital of Indiana

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lance Trexler, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Rehabilitation Hospital of Indiana

Locations

Rehabilitation Hospital of Indiana

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

F1J-US-X025

Identifier Type: OTHER

Identifier Source: secondary_id

RHI 05-096

Identifier Type: -

Identifier Source: org_study_id