A 4-week Study of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers
Primary Purpose
Healthy
Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Risperidone
Mifepristone
Risperidone-matched placebo
Mifepristone-matched placebo
Sponsored by
About this trial
This is an interventional prevention trial for Healthy focused on measuring healthy, weight gain, anti-psychotic, risperidone, mifepristone, mitigation, weight loss
Eligibility Criteria
Inclusion Criteria:
- BMI ≥ 18 and ≤ 23 kg/m2
- Able to provide written informed consent
- Routine clinical laboratory tests either within normal limits or not clinically meaningful if outside of normal limits
- AST, ALT, Tbili within normal limits at screening
- Medical and psychiatric history and physical examination devoid of any significant findings that would interfere with participation or interpretation of results in this study
- Agree to use a barrier method of birth control for 28 days following the last dose of study medication
- Have maintained a stable weight for at least 6 months prior to Screening
Exclusion Criteria:
- Prior or current history of any psychiatric disorder, including eating disorders such as anorexia nervosa, bulimia nervosa, or binge-eating disorder
- Positive urine drug screen for any drug of abuse (including amphetamines, cannabinoids, barbiturates, cocaine, opiates, benzodiazepines) unless prescribed by a physician
- Participation in a clinical investigation of any drug, biological or other investigational therapy within 30 days prior to dosing
- Have a history of an allergic reaction to either mifepristone or risperidone
- Any other clinically significant abnormality on screening laboratory tests
- QTc Bazzett's ≥ 450 msec
- History of or current major medical condition, which in the opinion of the Investigator would place the patient at undue risk.
- Receiving any prescription or over-the-counter medications that could potentially affect appetite or weight
- Any history of a movement disorder such as Tardive Dyskinesia, Parkinsonism
- Any personal or family history of Neuroleptic Malignant Syndrome
Sites / Locations
- Dhirubhai Ambani Life Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
Risperidone plus mifepristone
Risperidone plus mifepristone-matched placebo
Risperidone-matched placebo plus mifepristone
Arm Description
risperidone plus mifepristone daily for 28 days
risperidone plus mifepristone-matched placebo daily for 28 days
risperidone-matched placebo plus mifepristone daily for 28 days
Outcomes
Primary Outcome Measures
Change From Baseline in Body Weight
Secondary Outcome Measures
Percentage of Participants With <5% and <7% Increase From Baseline in Body Weight
Percentage of Participants With One or More Adverse Events
Percentage of Participants Discontinued From the Study Due to an Adverse Event
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00698022
Brief Title
A 4-week Study of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers
Official Title
A 4-week, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corcept Therapeutics
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a 28-day, single-center, double-blind, placebo-controlled inpatient study of the administration of risperidone alone or in combination with mifepristone in healthy adult male volunteers to determine the average change in absolute weight at Day 28 compared to baseline.
Detailed Description
This is a 28-day, single-center, double-blind, placebo-controlled inpatient study of the administration of risperidone alone or in combination with mifepristone in healthy adult male volunteers. The primary study objective is to determine the mean change in absolute weight at Day 28 compared to baseline in normal healthy male volunteers treated with risperidone plus mifepristone or risperidone alone. The secondary study objectives are to determine the mean percent change in baseline body weight; and the proportion of subjects that gain less than 5% and less than 7% of their baseline body in the treatment groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
healthy, weight gain, anti-psychotic, risperidone, mifepristone, mitigation, weight loss
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Risperidone plus mifepristone
Arm Type
Experimental
Arm Description
risperidone plus mifepristone daily for 28 days
Arm Title
Risperidone plus mifepristone-matched placebo
Arm Type
Placebo Comparator
Arm Description
risperidone plus mifepristone-matched placebo daily for 28 days
Arm Title
Risperidone-matched placebo plus mifepristone
Arm Type
Placebo Comparator
Arm Description
risperidone-matched placebo plus mifepristone daily for 28 days
Intervention Type
Drug
Intervention Name(s)
Risperidone
Other Intervention Name(s)
Risperdal
Intervention Description
risperidone daily for 28 days
Intervention Type
Drug
Intervention Name(s)
Mifepristone
Other Intervention Name(s)
Corlux
Intervention Description
mifepristone daily for 28 days
Intervention Type
Drug
Intervention Name(s)
Risperidone-matched placebo
Intervention Description
risperidone-matched placebo daily for 28 days
Intervention Type
Drug
Intervention Name(s)
Mifepristone-matched placebo
Intervention Description
mifepristone-matched placebo daily for 28 days
Primary Outcome Measure Information:
Title
Change From Baseline in Body Weight
Time Frame
Baseline and 28 days
Secondary Outcome Measure Information:
Title
Percentage of Participants With <5% and <7% Increase From Baseline in Body Weight
Time Frame
Baseline and 28 days
Title
Percentage of Participants With One or More Adverse Events
Time Frame
Up to 28 days
Title
Percentage of Participants Discontinued From the Study Due to an Adverse Event
Time Frame
Up to 28 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
BMI ≥ 18 and ≤ 23 kg/m2
Able to provide written informed consent
Routine clinical laboratory tests either within normal limits or not clinically meaningful if outside of normal limits
AST, ALT, Tbili within normal limits at screening
Medical and psychiatric history and physical examination devoid of any significant findings that would interfere with participation or interpretation of results in this study
Agree to use a barrier method of birth control for 28 days following the last dose of study medication
Have maintained a stable weight for at least 6 months prior to Screening
Exclusion Criteria:
Prior or current history of any psychiatric disorder, including eating disorders such as anorexia nervosa, bulimia nervosa, or binge-eating disorder
Positive urine drug screen for any drug of abuse (including amphetamines, cannabinoids, barbiturates, cocaine, opiates, benzodiazepines) unless prescribed by a physician
Participation in a clinical investigation of any drug, biological or other investigational therapy within 30 days prior to dosing
Have a history of an allergic reaction to either mifepristone or risperidone
Any other clinically significant abnormality on screening laboratory tests
QTc Bazzett's ≥ 450 msec
History of or current major medical condition, which in the opinion of the Investigator would place the patient at undue risk.
Receiving any prescription or over-the-counter medications that could potentially affect appetite or weight
Any history of a movement disorder such as Tardive Dyskinesia, Parkinsonism
Any personal or family history of Neuroleptic Malignant Syndrome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Coleman Gross, MD
Organizational Affiliation
Corcept Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Dhirubhai Ambani Life Sciences Centre
City
Mumbai
Country
India
12. IPD Sharing Statement
Citations:
PubMed Identifier
16782211
Citation
Beebe KL, Block T, Debattista C, Blasey C, Belanoff JK. The efficacy of mifepristone in the reduction and prevention of olanzapine-induced weight gain in rats. Behav Brain Res. 2006 Aug 10;171(2):225-9. doi: 10.1016/j.bbr.2006.03.039. Epub 2006 Jun 19.
Results Reference
background
Links:
URL
http://www.corcept.com
Description
Sponsor's Website
Learn more about this trial
A 4-week Study of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers
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