Study of Amantadine for Risperidone Consta or Paliperidone Treated Patients to Decrease Prolactin Elevation

This study has been terminated.
(The sponsor withdrew support due to slow accrual of eligible subjects.)
Sponsor:
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
David C. Henderson, MD, North Suffolk Mental Health Association
ClinicalTrials.gov Identifier:
NCT00975611
First received: September 10, 2009
Last updated: May 3, 2013
Last verified: January 2013
Results First Received: January 28, 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
Conditions: Schizophrenia
Schizoaffective Disorder
Interventions: Drug: Amantadine Hydrochloride, USP
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 were recruited from the Freedom Trail Clinic, MGH Schizophrenia Program

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria, and 1 screen failed due to a positive drug screen.

Reporting Groups
  Description
All Consented Subjects Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria, and 1 screen-failed due to a positive drug screen. Because of this unanticipated high screen-failure rate, the study was terminated. Not enough subjects were randomized (N=6), or completed (N=5), to merit statistical analysis between study arms. Therefore, only the baseline characteristics of all consented/screened subjects (N=22) were published and are reported here.

Participant Flow:   Overall Study
    All Consented Subjects  
STARTED     22  
COMPLETED     5  
NOT COMPLETED     17  
Screen Fail                 16  
Physician Decision                 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
All Consented Subjects Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria and 1 screen-failed due to a positive drug screen. Because of this unanticipated high screen-failure rate, the study was terminated. Not enough subjects were randomized or completed to merit statistical analysis between study arms. Therefore, only the baseline characteristics of all 22 consented/screened subjects were published and are reported here.

Baseline Measures
    All Consented Subjects  
Number of Participants  
[units: participants]
  22  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     22  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  43.14  ± 10.95  
Gender  
[units: participants]
 
Female     7  
Male     15  
Region of Enrollment  
[units: participants]
 
United States     22  



  Outcome Measures

1.  Primary:   Change in Prolactin Levels for Individuals Treated With Adjunctive Amantadine Versus Placebo.   [ Time Frame: week 4 and week 8 ]


  Serious Adverse Events


  Other Adverse Events


  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
Too few subjects met study's eligibility criteria to run statistical analyses on primary outcomes. The baseline demographic data are reported here. Future research is needed to understand the prevalence of elevated prolactin in schizophrenia.  


Results Point of Contact:  
Name/Title: Dr. David Henderson
Organization: Massachusetts General Hospital Schizophrenia Research Program
phone: (617) 912-7800
e-mail: dchenderson@partners.org


No publications provided


Responsible Party: David C. Henderson, MD, North Suffolk Mental Health Association
ClinicalTrials.gov Identifier: NCT00975611     History of Changes
Other Study ID Numbers: R076477PD14002
Study First Received: September 10, 2009
Results First Received: January 28, 2013
Last Updated: May 3, 2013
Health Authority: United States: Institutional Review Board