Clinical trial NCT00698022: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: healthy
weight gain
anti-psychotic
risperidone
mifepristone
mitigation
weight loss
Lead sponsor: Corcept Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-06-16
Enrollment: 76
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change From Baseline in Body Weight
timeFrame: Baseline and 28 days
Secondary outcomes:
measure: Percentage of Participants With <5% and <7% Increase From Baseline in Body Weight
timeFrame: Baseline and 28 days
measure: Percentage of Participants With One or More Adverse Events
timeFrame: Up to 28 days
measure: Percentage of Participants Discontinued From the Study Due to an Adverse Event
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Dhirubhai Ambani Life Sciences Centre
Study officials:
affiliation: Corcept Therapeutics
name: Coleman Gross, MD
role: STUDY_DIRECTOR
References:
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.