A 4-week Study of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers
Information source: Corcept Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: risperidone (Drug); risperidone matched placebo (Drug); risperidone-matched placebo (Drug); Mifepristone-matched placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Corcept Therapeutics Official(s) and/or principal investigator(s): Coleman Gross, MD, Study Director, Affiliation: Corcept Therapeutics
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Primary outcome: Change in Weight (kg) From Baseline to Day 28.
Secondary outcome: 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 Weight in the Treatment Groups.The Safety Objective is to Evaluate the Safety and Tolerability of Mifepristone in Combination With Risperidone in Healthy Male Volunteers.
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
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Male.
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
Locations and Contacts
Dhirubhai Ambani Life Sciences Centre, Mumbai, India
Additional Information
Sponsor's Website
Related publications: 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.
Starting date: November 2008
Last updated: May 1, 2012
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