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

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ClinicalTrials.gov Identifier: NCT00632229
Recruitment Status : Completed
First Posted : March 10, 2008
Results First Posted : February 6, 2014
Last Update Posted : February 6, 2014
Sponsor:
Collaborators:
Indiana University
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
University of South Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Obsessive-Compulsive Disorder
Interventions Drug: Paliperidone
Drug: Placebo
Enrollment 34
Recruitment Details Thirty-four adults with a principal diagnosis of OCD were recruited between May 2008 and March 2012.
Pre-assignment Details  
Arm/Group Title Paliperidone Placebo
Hide Arm/Group Description

Recieves study medication

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

Placebo comparator

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

Period Title: Overall Study
Started 17 17
Completed 11 11
Not Completed 6 6
Reason Not Completed
Adverse Event             6             0
Lost to Follow-up             0             3
Lack of Efficacy             0             2
Undisclosed reasons within the first wee             0             1
Arm/Group Title Paliperidone Placebo Total
Hide Arm/Group Description

Recieves study medication

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

Placebo comparator

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

Total of all reporting groups
Overall Number of Baseline Participants 17 17 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 34 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
 100.0%
16
  94.1%
33
  97.1%
>=65 years
0
   0.0%
1
   5.9%
1
   2.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 17 participants 34 participants
42.59  (9.99) 45.7  (12.27) 43.7  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 34 participants
Female
9
  52.9%
10
  58.8%
19
  55.9%
Male
8
  47.1%
7
  41.2%
15
  44.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 17 participants 34 participants
17 17 34
1.Primary Outcome
Title Yale Brown Obsessive Compulsive Scale
Hide Description This measure assesses obsessive-compulsive symptom severity across 10 items that are completed during an interview format with the person with OCD. These 10 items are summed to derive a total score, which ranges from 0-40 [Scale range: 0 (Minimum) - 40 (Maximum)] with higher scores corresponding to more severe obsessive-compulsive symptoms.
Time Frame End of study (8 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Paliperidone Placebo
Hide Arm/Group Description:

Recieves study medication

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

Placebo comparator

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

Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
19.14  (11.13) 21.24  (8.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paliperidone, Placebo
Comments To evaluate between-group continuous outcomes of the pilot controlled trial, ANCOVAs were performed, where 8-week outcome scores were predicted by treatment condition while covarying for baseline scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Clinical Global Impressions - Severity of Obsessive-Compulsive Symptoms
Hide Description This assessment measures the overall severity of obsessive-compulsive symptoms. It consists of a single item that is completed by a clinician with scores ranging from 0-6 with higher scores corresponding with more severe obsessive-compulsive symptoms. Thus, higher scores represent a worse outcome.
Time Frame post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Includes those subjects who were randomized to their respective condition.
Arm/Group Title Paliperidone Placebo
Hide Arm/Group Description:

Recieves study medication

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

Placebo comparator

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

Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
4.09  (1.66) 4.21  (1.29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paliperidone, Placebo
Comments To evaluate between-group continuous outcomes of the pilot controlled trial, ANCOVAs were performed, where 8-week outcome scores were predicted by treatment condition while covarying for baseline scores.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paliperidone Placebo
Hide Arm/Group Description

Recieves study medication

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

Placebo comparator

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

All-Cause Mortality
Paliperidone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Paliperidone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Paliperidone Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   15/17 (88.24%)   12/17 (70.59%) 
Ear and labyrinth disorders     
Ear Ringing   2/17 (11.76%)  2/17 (11.76%) 
Eye disorders     
blurred vision   3/17 (17.65%)  1/17 (5.88%) 
Gastrointestinal disorders     
dry mouth   4/17 (23.53%)  3/17 (17.65%) 
Nausea   0/17 (0.00%)  3/17 (17.65%) 
Constipation   5/17 (29.41%)  1/17 (5.88%) 
Diarrhea   1/17 (5.88%)  2/17 (11.76%) 
Increased Appetite   5/17 (29.41%)  3/17 (17.65%) 
Decreased Appetite   1/17 (5.88%)  1/17 (5.88%) 
General disorders     
Somnolence   7/17 (41.18%)  8/17 (47.06%) 
Insomnia   5/17 (29.41%)  5/17 (29.41%) 
Agitation   4/17 (23.53%)  2/17 (11.76%) 
Nervous system disorders     
Headache   4/17 (23.53%)  6/17 (35.29%) 
Dizziness   3/17 (17.65%)  4/17 (23.53%) 
Lightheadness   3/17 (17.65%)  3/17 (17.65%) 
Muscle Stiffness   4/17 (23.53%)  0/17 (0.00%) 
Shakiness   1/17 (5.88%)  1/17 (5.88%) 
Psychiatric disorders     
Anxiety   1/17 (5.88%)  1/17 (5.88%) 
Renal and urinary disorders     
Increased need to urinate   4/17 (23.53%)  1/17 (5.88%) 
Reproductive system and breast disorders     
Galactorrhea   2/17 (11.76%)  0/17 (0.00%) 
Indicates events were collected by systematic assessment

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

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
Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT00632229     History of Changes
Other Study ID Numbers: USF 08-0100
First Submitted: February 29, 2008
First Posted: March 10, 2008
Results First Submitted: October 23, 2013
Results First Posted: February 6, 2014
Last Update Posted: February 6, 2014