Riluzole Augmentation in Treatment-refractory Obsessive-compulsive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00523718
First received: August 29, 2007
Last updated: February 22, 2016
Last verified: February 2016
Results First Received: February 22, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Obsessive-compulsive Disorder
Ocd
Interventions: Drug: riluzole
Drug: 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
Subjects with SRI-refractory OCD were recruited through the Yale OCT Research Clinic between November 2006 and December 2012 using print and internet advertisements, community outreach, and physician referrals.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Forty subjects with treatment-refractory OCD were consented; 1 dropped out after consent, and one was excluded after it was revealed they were not taking an SSRI. These individuals were not randomized.

Reporting Groups
  Description
Riluzole

Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment

riluzole: 50 mg PO bid, 12 weeks

Placebo

Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.

placebo: placebo, 1 capsule PO bid, 12 weeks


Participant Flow:   Overall Study
    Riluzole     Placebo  
STARTED     20     18  
COMPLETED     17     18  
NOT COMPLETED     3     0  
Withdrawal by Subject                 1                 0  
Protocol Violation                 2                 0  



  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.
One individual was excluded from analysis (they were in the riluzole group) before unblinding due to a protocol violation.

Reporting Groups
  Description
Riluzole

Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment

riluzole: 50 mg PO bid, 12 weeks

Placebo

Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.

placebo: placebo, 1 capsule PO bid, 12 weeks

Total Total of all reporting groups

Baseline Measures
    Riluzole     Placebo     Total  
Number of Participants  
[units: participants]
  19     18     37  
Age  
[units: years]
Mean (Standard Deviation)
  41.5  (3.2)     36.4  (3.1)     38.52  (13.80)  
Gender  
[units: participants]
     
Female     11     9     20  
Male     8     9     17  
Race/Ethnicity, Customized  
[units: participants]
     
White     19     16     35  
African American     0     2     2  
Y-BOCS baseline score [1]
[units: units on a scale]
Mean (Standard Deviation)
  30  (5.12)     30.73  (5.81)     30.37  (5.41)  
HDRS baseline score [2]
[units: units on a scale]
Mean (Standard Deviation)
  12.68  (6.89)     13.05  (6.19)     12.87  (6.46)  
HARS baseline score [3]
[units: units on a scale]
Mean (Standard Deviation)
  16.2  (7.35)     15.95  (6.433)     16.08  (6.80)  
[1]

The Yale–Brown Obsessive Compulsive Scale (Y-BOCS) is a test to rate the severity of obsessive–compulsive disorder (OCD) symptoms. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms), yielding a total possible score range from 0 to 40. The results can be interpreted based on the total score:

0–7 is sub-clinical; 8–15 is mild; 16–23 is moderate; 24–31 is severe; 32–40 is extreme.

[2] The HDRS (also known as the Ham-D) is the most widely used clinician-administered depression assessment scale.The HAM-D ranges from 0 (Normal) to >23 (Very Severe Depression).
[3] The Hamilton Anxiety Rating Scale (HARS) is a psychological questionnaire used by clinicians to rate the severity of a patient's anxiety. Total score ranges from 0 to 56. A score of 17 or less indicates mild anxiety severity. A score from 18 to 24 indicates mild to moderate anxiety severity. Lastly, a score of 25 to 30 indicates a moderate to severe anxiety severity.



  Outcome Measures
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1.  Primary:   Partial Responders by Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)   [ Time Frame: 14 weeks ]

2.  Secondary:   Average Hamilton Depression Inventory (HAM-D)   [ Time Frame: 14 weeks ]

3.  Secondary:   Average Hamilton Anxiety Inventory (HAM-A)   [ Time Frame: 14 weeks ]

4.  Secondary:   Clinical Global Impression (CGI) - Severity of Illness Item   [ Time Frame: 14 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
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  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: Christopher Pittenger
Organization: Yale University
phone: (203) 974-7675
e-mail: christopher.pittenger@yale.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00523718     History of Changes
Other Study ID Numbers: YOCD-1
Study First Received: August 29, 2007
Results First Received: February 22, 2016
Last Updated: February 22, 2016
Health Authority: United States: Institutional Review Board