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Trial record 7 of 310 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects recruited from in-patient and medical clinic population. All subjects suffering from traumatic brain injury and loss of cognitive function.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.
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.

Participant Flow:   Overall Study
    Duloxetine   Sugar Pill
STARTED   4   4 
COMPLETED   0   0 
NOT COMPLETED   4   4 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
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.
Total Total of all reporting groups

Baseline Measures
   Duloxetine   Sugar Pill   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   4   8 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   4   4   8 
>=65 years   0   0   0 
Gender 
[Units: Participants]
     
Female   0   1   1 
Male   4   3   7 
Region of Enrollment 
[Units: Participants]
     
United States   4   4   8 


  Outcome Measures

1.  Primary:   Hamilton Rating Scale for Depression   [ Time Frame: 9 months ]

2.  Secondary:   Hopkins Verbal Learning Test   [ Time Frame: 9 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: lance.trexler@rhin.com



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