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N-Acetylcysteine Augmentation in Treatment-Refractory Obsessive-Compulsive Disorder

This study has been terminated.
(Researchers terminated study due to limited enrollment.)
Sponsor:
Information provided by (Responsible Party):
Christopher Pittenger, Yale University
ClinicalTrials.gov Identifier:
NCT00539513
First received: October 2, 2007
Last updated: March 25, 2013
Last verified: March 2013
History of Changes
Results First Received: December 21, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Obsessive-Compulsive Disorder
Interventions: Drug: N-Acetylcysteine
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
N-Acetylcysteine

Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment

N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks
Placebo

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

placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks

Participant Flow:   Overall Study
    N-Acetylcysteine     Placebo  
STARTED     5     5  
Received Allocated Intervention     3     4  
COMPLETED     3     3  
NOT COMPLETED     2     2  
Withdrawal by Subject                 2                 1  
Lost to Follow-up                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
N-Acetylcysteine

Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment

N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks
Placebo

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

placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks
Total Total of all reporting groups

Baseline Measures
    N-Acetylcysteine     Placebo     Total  
Number of Participants  
[units: participants]
 		  5     5     10  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     5     5     10  
>=65 years     0     0     0  
Gender  
[units: participants]
 		     
Female     2     2     4  
Male     3     3     6  



  Outcome Measures
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1.  Primary:   Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)at Baseline   [ Time Frame: Baseline ]
  Show Outcome Measure 1

2.  Primary:   Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)at 12 Weeks   [ Time Frame: 12 Weeks ]
  Show Outcome Measure 2

3.  Secondary:   The Hamilton Depression Inventory (HAM-D)at Baseline   [ Time Frame: Baseline ]
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4.  Secondary:   The Hamilton Depression Inventory (HAM-D)at 12 Weeks   [ Time Frame: 12 weeks ]
  Show Outcome Measure 4


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


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
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Results Point of Contact:  
Name/Title: Christopher Pittenger, MD Ph.D
Organization: Yale University School of Medicine
phone: 203-974-7675
e-mail: christopher.pittenger@yale.edu


Publications:


Responsible Party: Christopher Pittenger, Yale University
ClinicalTrials.gov Identifier: NCT00539513     History of Changes
Other Study ID Numbers: YOCD-2
Study First Received: October 2, 2007
Results First Received: December 21, 2012
Last Updated: March 25, 2013
Health Authority: United States: Institutional Review Board