A 4-week Study of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers
Condition: Healthy
MeSH terms: Weight Gain
Intervention: Risperidone; Mifepristone; Risperidone-matched placebo; Mifepristone-matched placebo
Intervention description: risperidone daily for 28 days; mifepristone daily for 28 days; risperidone-matched placebo daily for 28 days; mifepristone-matched placebo daily for 28 days
Intervention MeSH terms: Risperidone; Mifepristone
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 76.0
Sex: Male
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: healthy; weight gain; anti-psychotic; risperidone; mifepristone; mitigation; weight loss

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.
    

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