A 4-week Study of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00698022
• Other study ID #: C-1073-205
• Status: Completed
• Phase: Phase 1
• Start date: November 2008
• Est. completion date: February 2009

Study information

• Verified date: February 2022
• Source: Corcept Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Weight Gain

Intervention

Drug:
• Risperidone
risperidone daily for 28 days
• Mifepristone
mifepristone daily for 28 days
• Risperidone-matched placebo
risperidone-matched placebo daily for 28 days
• Mifepristone-matched placebo
mifepristone-matched placebo daily for 28 days

Locations

Country	Name	City	State
India	Dhirubhai Ambani Life Sciences Centre	Mumbai

Sponsors (1)

Lead Sponsor	Collaborator
Corcept Therapeutics

Country where clinical trial is conducted

India, 

References & 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. Epub 2006 Jun 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Body Weight		Baseline and 28 days
Secondary	Percentage of Participants With <5% and <7% Increase From Baseline in Body Weight		Baseline and 28 days
Secondary	Percentage of Participants With One or More Adverse Events		Up to 28 days
Secondary	Percentage of Participants Discontinued From the Study Due to an Adverse Event		Up to 28 days

External Links

•   Sponsor's Website