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

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ClinicalTrials.gov Identifier: NCT00698022
Recruitment Status : Completed
First Posted : June 16, 2008
Results First Posted : May 4, 2012
Last Update Posted : February 8, 2022
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Risperidone Drug: Mifepristone Drug: Risperidone-matched placebo Drug: Mifepristone-matched placebo Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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 Start Date : November 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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Arm Intervention/treatment
Experimental: Risperidone plus mifepristone
risperidone plus mifepristone daily for 28 days
 Drug: Risperidone
risperidone daily for 28 days
Other Name: Risperdal

Drug: Mifepristone
mifepristone daily for 28 days
Other Name: Corlux
Placebo Comparator: Risperidone plus mifepristone-matched placebo
risperidone plus mifepristone-matched placebo daily for 28 days
 Drug: Risperidone
risperidone daily for 28 days
Other Name: Risperdal

Drug: Mifepristone-matched placebo
mifepristone-matched placebo daily for 28 days
Placebo Comparator: Risperidone-matched placebo plus mifepristone
risperidone-matched placebo plus mifepristone daily for 28 days
 Drug: Mifepristone
mifepristone daily for 28 days
Other Name: Corlux

Drug: Risperidone-matched placebo
risperidone-matched placebo daily for 28 days


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Body Weight [ Time Frame: Baseline and 28 days ]

Secondary Outcome Measures :
  1. Percentage of Participants With <5% and <7% Increase From Baseline in Body Weight [ Time Frame: Baseline and 28 days ]
  2. Percentage of Participants With One or More Adverse Events [ Time Frame: Up to 28 days ]
  3. Percentage of Participants Discontinued From the Study Due to an Adverse Event [ Time Frame: Up to 28 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00698022


Locations
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India
Dhirubhai Ambani Life Sciences Centre
Mumbai, India
Sponsors and Collaborators
Corcept Therapeutics
Investigators
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Study Director: Coleman Gross, MD Corcept Therapeutics
More Information
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Additional Information:

Publications:

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Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT00698022    
Other Study ID Numbers: C-1073-205
First Posted: June 16, 2008    Key Record Dates
Results First Posted: May 4, 2012
Last Update Posted: February 8, 2022
Last Verified: February 2022
Keywords provided by Corcept Therapeutics:
healthy
weight gain
anti-psychotic
risperidone
 mifepristone
mitigation
weight loss
Additional relevant MeSH terms:
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Weight Gain
Body Weight Changes
Body Weight
Risperidone
Mifepristone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
 Dopamine Agents
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Contraceptive Agents, Hormonal
Menstruation-Inducing Agents