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Memantine Augmentation in Obsessive-Compulsive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John J Barry, Stanford University
ClinicalTrials.gov Identifier:
NCT00264238
First received: December 9, 2005
Last updated: April 19, 2017
Last verified: April 2017
Results First Received: November 7, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Obsessive-Compulsive Disorder
Intervention: Drug: Memantine

  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
From February 2006 to February 2008, participants recruited from the Stanford School of Medicine Department of Psychiatry and Behavioral Sciences OCD clinic and through online adds. Subjects had to have had failed to respond to at least 12 weeks of treatment at an adequate and stable dose of an serotonin reuptake inhibitor (SRI) (YBOCS of GE 18)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Memantine Open Label

All subjects knowingly received (open label) memantine for up to 12 weeks with a target dose of 10 mg twice a day (20mg/d) taken orally.

Memantine: pharmacological dosing of memantine as adjunctive therapy for treatment-resistant obsessive-compulsive disorder


Participant Flow:   Overall Study
    Memantine Open Label
STARTED   15 
COMPLETED   14 
NOT COMPLETED   1 
Protocol Violation                1 



  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.
No text entered.

Reporting Groups
  Description
Memantine Open Label

All subjects knowingly received (open label) memantine for up to 12 weeks with a target dose of 10 mg twice a day (20mg/d) taken orally.

Memantine: pharmacological dosing of memantine as adjunctive therapy for treatment-resistant obsessive-compulsive disorder


Baseline Measures
   Memantine Open Label 
Overall Participants Analyzed 
[Units: Participants]
 14 
Age 
[Units: Years]
Mean (Standard Deviation)
 37.3  (13.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      5  35.7% 
Male      9  64.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      14 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   14 
Yale-Brown Obsessive Compulsive Scale [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 27.4  (5) 
[1] The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) is designed to rate the severity and type of symptoms in patients with obsessive compulsive disorder. In general, the items depend on the patient's report; however, the final rating is based on the clinical judgement of the interviewer. The Y-BOCS is designed to rate symptom severity, not to establish a diagnosis.The scale consists of 10 items summed to determine the level of symptom severity. The total score ranges from 0 to 40 with higher scores indicating greater symptom severity
Psychiatric comorbid condition 
[Units: Participants]
 
Participants with comorbid condition   8 
Participants without comorbid condition   6 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) From Baseline to End of Treatment (12 Weeks)   [ Time Frame: Baseline and 12 weeks ]

2.  Secondary:   Mean Change in Montgomery-Asberg Depression Rating Scale (MADRS) From Baseline to End of Treatment (12 Weeks)   [ Time Frame: Baseline and 12 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
This study is limited by its open-label design, small size, and the presence of comorbidities and concurrent psychotropic medications


  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 John Barry, Professor
Organization: Stanford University School of Medicine, Dept of Psychiatry
phone: (650) 725-5588
e-mail: jbarry@stanford.edu


Publications of Results:

Responsible Party: John J Barry, Stanford University
ClinicalTrials.gov Identifier: NCT00264238     History of Changes
Other Study ID Numbers: SUSPO34313
Study First Received: December 9, 2005
Results First Received: November 7, 2016
Last Updated: April 19, 2017