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Trial record 12 of 12 for:    "Hyperprolactinemia" | "Tranquilizing Agents"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00975611
Recruitment Status : Terminated (The sponsor withdrew support due to slow accrual of eligible subjects.)
First Posted : September 11, 2009
Results First Posted : June 10, 2013
Last Update Posted : June 10, 2013
Sponsor:
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
David C. Henderson, MD, North Suffolk Mental Health Association

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Schizophrenia
Schizoaffective Disorder
Interventions Drug: Amantadine Hydrochloride, USP
Drug: Placebo
Enrollment 6
Recruitment Details Subjects were recruited from the Freedom Trail Clinic, MGH Schizophrenia Program
Pre-assignment Details 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.
Arm/Group Title All Consented Subjects
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 22
Completed 5
Not Completed 17
Reason Not Completed
Screen Fail             16
Physician Decision             1
Arm/Group Title All Consented Subjects
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
<=18 years
0
   0.0%
Between 18 and 65 years
22
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants
43.14  (10.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
7
  31.8%
Male
15
  68.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants
22
1.Primary Outcome
Title Change in Prolactin Levels for Individuals Treated With Adjunctive Amantadine Versus Placebo.
Hide Description [Not Specified]
Time Frame week 4 and week 8
Hide Outcome Measure Data
Hide Analysis Population Description
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. Only baseline characteristics of all 22 consented/screened subjects were published and are reported here.
Arm/Group Title All Consented Subjects
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame entire study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Consented Subjects
Hide Arm/Group Description 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.
All-Cause Mortality
All Consented Subjects
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Consented Subjects
Affected / at Risk (%)
Total   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Consented Subjects
Affected / at Risk (%)
Total   0/6 (0.00%) 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. David Henderson
Organization: Massachusetts General Hospital Schizophrenia Research Program
Phone: (617) 912-7800
EMail: dchenderson@partners.org
Layout table for additonal information
Responsible Party: David C. Henderson, MD, North Suffolk Mental Health Association
ClinicalTrials.gov Identifier: NCT00975611     History of Changes
Other Study ID Numbers: R076477PD14002
First Submitted: September 10, 2009
First Posted: September 11, 2009
Results First Submitted: January 28, 2013
Results First Posted: June 10, 2013
Last Update Posted: June 10, 2013