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

Primary Purpose

Traumatic Brain Injury, Depression

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Duloxetine

Sugar pill

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Depression, Traumatic brain injury, Duloxetine, Cymbalta, impaired cognitive function

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rehabilitation Hospital of Indiana

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Duloxetine

Sugar pill

Arm 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.

Outcomes

Primary Outcome Measures

Hamilton Rating Scale for Depression

To compare the efficacy of duloxetine 30 mg. PO daily to 120mg. PO daily with placebo in the prevention of depression associated with mild/moderate traumatic brain injury, utilizing the Hamilton Rating Scale for Depression (Hamilton, 1960; HAM-D) as the primary efficacy measure.

Secondary Outcome Measures

Hopkins Verbal Learning Test

To compare the effect of duloxetine vs. placebo on the recovery of memory functions of patients with traumatic brain injury, utilizing the 20-minute delayed recall score of the Hopkins Verbal Learning Test (Brandt, 1991) as the secondary efficacy measure.

Full Information

NCT ID

NCT01223001

First Posted

October 15, 2010

Last Updated

December 15, 2014

Sponsor

Rehabilitation Hospital of Indiana

Collaborators

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01223001

Brief Title

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

Acronym

Duloxetine

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2014

Overall Recruitment Status

Terminated

Why Stopped

Most potential subjects had already been prescribed Cymbalta.

Study Start Date

September 1996 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rehabilitation Hospital of Indiana

Collaborators

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Traumatic Brain Injury, Depression

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Duloxetine

Arm Type

Active Comparator

Arm 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.

Arm Title

Sugar pill

Arm Type

Placebo Comparator

Arm Description

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

Intervention Name(s)

Duloxetine

Other Intervention Name(s)

Cymbalta

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.

Intervention Type

Drug

Intervention Name(s)

Sugar pill

Other Intervention Name(s)

Lactose

Intervention Description

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.

Primary Outcome Measure Information:

Title

Hamilton Rating Scale for Depression

Description

Time Frame

9 months

Secondary Outcome Measure Information:

Title

Hopkins Verbal Learning Test

Description

Time Frame

9 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lance Trexler, Ph.D.

Organizational Affiliation

Rehabilitation Hospital of Indiana

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rehabilitation Hospital of Indiana

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46254

Country

United States

12. IPD Sharing Statement

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

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