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Trial record 7 of 315 for:    duloxetine

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

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ClinicalTrials.gov Identifier: NCT01223001
Recruitment Status : Terminated (Most potential subjects had already been prescribed Cymbalta.)
First Posted : October 18, 2010
Results First Posted : December 17, 2014
Last Update Posted : December 17, 2014
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Rehabilitation Hospital of Indiana

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Traumatic Brain Injury
Depression
Interventions Drug: Duloxetine
Drug: Sugar pill
Enrollment 8
Recruitment Details Subjects recruited from in-patient and medical clinic population. All subjects suffering from traumatic brain injury and loss of cognitive function.
Pre-assignment Details All subjects performed cognitive testing and assessment for depression. No subjects with seizure disorder or substance abuse issues or previous psychiatric history enrolled. Subjects excluded from the study had previously been prescribed Duloxetine.
Arm/Group Title Duloxetine Sugar Pill
Hide Arm/Group 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.
Period Title: Overall Study
Started 4 4
Completed 0 0
Not Completed 4 4
Arm/Group Title Duloxetine Sugar Pill Total
Hide Arm/Group 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. Total of all reporting groups
Overall Number of Baseline Participants 4 4 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 8 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
4
 100.0%
8
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 8 participants
Female
0
   0.0%
1
  25.0%
1
  12.5%
Male
4
 100.0%
3
  75.0%
7
  87.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 4 participants 8 participants
4 4 8
1.Primary Outcome
Title Hamilton Rating Scale for Depression
Hide Description 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.
Time Frame 9 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was not conducted. Study was terminated before interim analysis. Raw data is stored in a secure location, but not able to be accessed.
Arm/Group Title Duloxetine Sugar Pill
Hide Arm/Group 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.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Hopkins Verbal Learning Test
Hide Description 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.
Time Frame 9 months
Outcome Measure Data Not Reported
Time Frame Duration of study participation per subject.
Adverse Event Reporting Description Subjects did not experience adverse events of any type.
 
Arm/Group Title Duloxetine Sugar Pill
Hide Arm/Group 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.
All-Cause Mortality
Duloxetine Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Duloxetine Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Duloxetine Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%) 
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Lance Trexler
Organization: The Rehabilitation Hospital of Indiana
Phone: (317)879-8940
Responsible Party: Rehabilitation Hospital of Indiana
ClinicalTrials.gov Identifier: NCT01223001     History of Changes
Other Study ID Numbers: RHI 05-096
F1J-US-X025 ( Other Identifier: Eli Lilly and Co. )
First Submitted: October 15, 2010
First Posted: October 18, 2010
Results First Submitted: November 6, 2014
Results First Posted: December 17, 2014
Last Update Posted: December 17, 2014