A 4-week Study of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers
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
1 other identifier
interventional
76
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Nov 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2008
CompletedFirst Posted
Study publicly available on registry
June 16, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedResults Posted
Study results publicly available
May 4, 2012
CompletedFebruary 8, 2022
February 1, 2022
3 months
June 12, 2008
November 4, 2010
February 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Body Weight
Baseline and 28 days
Secondary Outcomes (3)
Percentage of Participants With <5% and <7% Increase From Baseline in Body Weight
Baseline and 28 days
Percentage of Participants With One or More Adverse Events
Up to 28 days
Percentage of Participants Discontinued From the Study Due to an Adverse Event
Up to 28 days
Study Arms (3)
Risperidone plus mifepristone
EXPERIMENTALrisperidone plus mifepristone daily for 28 days
Risperidone plus mifepristone-matched placebo
PLACEBO COMPARATORrisperidone plus mifepristone-matched placebo daily for 28 days
Risperidone-matched placebo plus mifepristone
PLACEBO COMPARATORrisperidone-matched placebo plus mifepristone daily for 28 days
Interventions
risperidone daily for 28 days
mifepristone daily for 28 days
risperidone-matched placebo daily for 28 days
mifepristone-matched placebo daily for 28 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dhirubhai Ambani Life Sciences Centre
Mumbai, India
Related Publications (1)
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.
PMID: 16782211BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert Roe, MD
- Organization
- Corcept_Therapeutics
Study Officials
- STUDY DIRECTOR
Coleman Gross, MD
Corcept Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2008
First Posted
June 16, 2008
Study Start
November 1, 2008
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
February 8, 2022
Results First Posted
May 4, 2012
Record last verified: 2022-02