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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics
ClinicalTrials.gov Identifier:
NCT00698022
First received: June 12, 2008
Last updated: May 1, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Healthy
Drug: risperidone
Drug: risperidone matched placebo
Drug: risperidone-matched placebo
Drug: Mifepristone-matched placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Corcept Therapeutics:

Primary Outcome Measures:
  • Change in Weight (kg) From Baseline to Day 28. [ Time Frame: baseline and 28 days ] [ Designated as safety issue: No ]
    Change in weight (kg) was compared at Baseline and Day 28 for all subjects in all treatment arms.


Secondary Outcome Measures:
  • 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. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • The Safety Objective is to Evaluate the Safety and Tolerability of Mifepristone in Combination With Risperidone in Healthy Male Volunteers. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Enrollment: 76
Study Start Date: November 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Risperidone plus mifepristone
risperidone plus mifepristone daily for 28 days
Drug: risperidone
daily risperidone plus mifepristone for 28 days
Other Name: Risperdal
Placebo Comparator: risperidone plus mifepristone-matched placebo
risperidone plus mifepristone-matched placebo daily for 28 days
Drug: Mifepristone-matched placebo
daily mifepristone-matched placebo for 28 days
Other Names:
  • Corlux
  • Risperdal
Placebo Comparator: risperidone matched-placebo plus mifepristone
risperidone-matched placebo plus mifepristone daily for 28 days
Drug: risperidone matched placebo
risperidone-matched placebo plus mifepristone daily for 28 days
Other Names:
  • Risperdal
  • Corlux
Drug: risperidone-matched placebo
daily risperidone-matched placebo plus mifepristone for 28 days
Other Name: Risperdal

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

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698022

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

Additional Information:
Publications:
Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT00698022     History of Changes
Other Study ID Numbers: C-1073-205
Study First Received: June 12, 2008
Results First Received: November 4, 2010
Last Updated: May 1, 2012
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India

Keywords provided by Corcept Therapeutics:
healthy
weight gain
anti-psychotic
risperidone
mifepristone
mitigation
weight loss

Additional relevant MeSH terms:
Weight Gain
Body Weight Changes
Body Weight
Signs and Symptoms
Mifepristone
Risperidone
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Abortifacient Agents, Steroidal
Abortifacient Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 28, 2014