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

NCT01223001 | Terminated Phase 2 Results DMC

• 2 other identifiers: RHI 05-096F1J-US-X025
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Depression

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  9 months

Secondary Outcomes (1)

• Hopkins Verbal Learning Test

  9 months

Study Arms (2)

Duloxetine

ACTIVE COMPARATOR

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.

Drug: Duloxetine

Sugar pill

PLACEBO COMPARATOR

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.

Drug: Sugar pill

Interventions

Duloxetine 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.

Also known as: Cymbalta

Duloxetine

Sugar pill 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.

Also known as: Lactose

Sugar pill

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rehabilitation Hospital of Indiana: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Rehabilitation Hospital of Indiana

Indianapolis, Indiana, 46254, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Depression

Interventions

Duloxetine Hydrochloride; Sugars; Lactose

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbohydrates; Disaccharides; Oligosaccharides; Polysaccharides

Limitations and Caveats

All subjects excluded (n=6) had already been prescribed Duloxetine. Completion of the study by the remaining 4 per group was not achieved due to noncompliance.

Results Point of Contact

• Title: Dr. Lance Trexler
• Organization: The Rehabilitation Hospital of Indiana

lance.trexler@rhin.com

(317)879-8940

Study Officials

• Lance Trexler, Ph.D.

  Rehabilitation Hospital of Indiana

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2010
• First Posted: October 18, 2010
• Study Start: September 1, 1996
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: December 17, 2014
• Results First Posted: December 17, 2014

Record last verified: 2014-11

Locations

US (1)