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Double Blinded, Placebo-Controlled Trial of Paliperidone Addition in SRI-Resistant Obsessive-Compulsive Disorder

This study has been completed.
Sponsor:
Collaborators:
Indiana University
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT00632229
First received: February 29, 2008
Last updated: December 19, 2013
Last verified: October 2013
Results First Received: October 23, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Obsessive-Compulsive Disorder
Interventions: Drug: Paliperidone
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
Thirty-four adults with a principal diagnosis of OCD were recruited between May 2008 and March 2012.

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
Paliperidone

Recieves study medication

Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy.

Placebo

Placebo comparator

Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy.


Participant Flow:   Overall Study
    Paliperidone     Placebo  
STARTED     17     17  
COMPLETED     11     11  
NOT COMPLETED     6     6  
Adverse Event                 6                 0  
Lost to Follow-up                 0                 3  
Lack of Efficacy                 0                 2  
Undisclosed reasons within the first wee                 0                 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
Paliperidone

Recieves study medication

Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy.

Placebo

Placebo comparator

Paliperidone : Paliperidone medication taken daily ranging from 3-9mg/day depending on tolerability and efficacy.

Total Total of all reporting groups

Baseline Measures
    Paliperidone     Placebo     Total  
Number of Participants  
[units: participants]
  17     17     34  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     17     16     33  
>=65 years     0     1     1  
Age  
[units: years]
Mean ± Standard Deviation
  42.59  ± 9.99     45.7  ± 12.27     43.7  ± 11.4  
Gender  
[units: participants]
     
Female     9     10     19  
Male     8     7     15  
Region of Enrollment  
[units: participants]
     
United States     17     17     34  



  Outcome Measures
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1.  Primary:   Yale Brown Obsessive Compulsive Scale   [ Time Frame: End of study (8 weeks) ]

2.  Secondary:   Clinical Global Impressions - Severity of Obsessive-Compulsive Symptoms   [ Time Frame: post-treatment ]


  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

Modest sample and analyses were potentially underpowered to detect between-group differences on OCD measures.

It was not possible to determine response from participants' current medication.

Little racial/ethnic and socioeconomic variability



  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. Eric Storch
Organization: University of South Florida
phone: 727-767-8230
e-mail: estorch@health.usf.edu


No publications provided by University of South Florida

Publications automatically indexed to this study:

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT00632229     History of Changes
Other Study ID Numbers: USF 08-0100
Study First Received: February 29, 2008
Results First Received: October 23, 2013
Last Updated: December 19, 2013
Health Authority: United States: Food and Drug Administration