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Treatment of Mild to Moderate Depression Symptoms in Patients With Spinal Cord Injury

This study has been completed.
Sponsor:
Collaborator:
U.S. Department of Education
Information provided by (Responsible Party):
Denise Tate, University of Michigan
ClinicalTrials.gov Identifier:
NCT00735670
First received: August 14, 2008
Last updated: October 7, 2016
Last verified: October 2016
Results First Received: April 3, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Spinal Cord Injury
Interventions: Drug: Venlafaxine HCl
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment into the final protocol began in May 2009 and continued through July 2011. Participants were recruited from the surrounding community through clinics, existing research studies, and community organizations.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Because of challenges of recruiting inpatients with new injuries, the final modification to the protocol was to restrict inclusion criteria to those with chronic SCI (>6 months after injury) and the objective of the study shifted from preventing a major depressive episode to a reduction in symptoms. Therefore 13 / 34 enrolled were ineligible.

Reporting Groups
  Description
Venlafaxine Venlafaxine HCl is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and has been approved by the FDA for the treatment of major depressive disorder. The treatment group will receive a sub-therapeutic dose over a two week period, with a two week titration, starting at 37.5 mg up to a maximum dose of 150 mg per day. At the end of the treatment period, dosage was tapered down in a step-wise fashion over a period of three weeks; 75 mg. for two weeks and 37.5 mg. for one week. While this was the standard protocol, study drug tapering was individualized based on side effects and the clinical judgment of the prescriber.
Placebo Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.

Participant Flow:   Overall Study
    Venlafaxine   Placebo
STARTED   10   11 
COMPLETED   6   6 
NOT COMPLETED   4   5 



  Baseline Characteristics
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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.
Participants meeting eligibility criteria for the final protocol version.

Reporting Groups
  Description
Venlafaxine Venlafaxine HCl is classified as a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) and has been approved by the FDA for the treatment of major depressive disorder. The treatment group will receive a sub-therapeutic dose over a two week period, with a two week titration, starting at 37.5 mg up to a maximum dose of 150 mg per day. At the end of the treatment period, dosage was tapered down in a step-wise fashion over a period of three weeks; 75 mg. for two weeks and 37.5 mg. for one week. While this was the standard protocol, study drug tapering was individualized based on side effects and the clinical judgment of the prescriber.
Placebo Placebo capsules were compounded by filling a matching gelatin capsule with lactose. Titration up and down followed the same schedule as the treatment group.
Total Total of all reporting groups

Baseline Measures
   Venlafaxine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   11   21 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   10   10   20 
>=65 years   0   1   1 
Age 
[Units: Years]
Mean (Standard Deviation)
 45.4  (10.5)   51.7  (14.1)   48.7  (12.6) 
Gender 
[Units: Participants]
     
Female   2   2   4 
Male   8   9   17 
Region of Enrollment 
[Units: Participants]
     
United States   10   11   21 
Time since injury 
[Units: Years]
Mean (Standard Deviation)
 10.01  (9.0)   13.64  (15.1)   11.9  (10.0) 
Level of injury 
[Units: Participants]
     
Tetraplegia   6   1   7 
Paraplegia   4   10   14 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   16-Item Quick Inventory of Depressive Symptomatology – Self Report (QIDS-SR16)   [ Time Frame: Baseline and Week 13 ]

2.  Secondary:   Depression Scale of the Patient Health Questionnaire (PHQ-9)   [ Time Frame: Baseline and weeks 1, 2, 3, 5, 9, 13, 14, 15, 16, 18, 20 and 26 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
Difficulties with recruitment and high rate of withdrawal (57%) resulted in a very small sample. As such, results must be taken with caution given low power in this study.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Denise G Tate
Organization: University of Michigan Spinal Cord Injury System
phone: 734 763-0971
e-mail: dgtate@umich.edu



Responsible Party: Denise Tate, University of Michigan
ClinicalTrials.gov Identifier: NCT00735670     History of Changes
Other Study ID Numbers: NDNO60032SS
NIDRRH133N060032
Study First Received: August 14, 2008
Results First Received: April 3, 2013
Last Updated: October 7, 2016
Health Authority: United States: Institutional Review Board