Full Text View
Tabular View
No Study Results Posted
Related Studies
A 4-Week Study of Mifepristone in the Prevention of Risperidone-Induced Weight Gain in Healthy Male Volunteers
This study has been completed.
First Received: June 12, 2008   Last Updated: February 2, 2009   History of Changes
Sponsored by: Corcept Therapeutics
Information provided by: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT00698022
  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 plus mifepristone
Drug: risperidone plus placebo
Drug: risperidone-matched placebo plus mifepristone
Phase II

Drug Information available for: Mifepristone Risperidone
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Corcept Therapeutics:

Primary Outcome Measures:
  • 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. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

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 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 ]

Estimated Enrollment: 100
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
1: Experimental Drug: risperidone plus mifepristone
daily risperidone plus mifepristone for 28 days
2: Placebo Comparator
risperidone plus mifepristone-matched placebo
Drug: risperidone plus placebo
daily risperidone plus placebo for 28 days
3: Placebo Comparator
risperidone-matched placebo plus mifepristone
Drug: risperidone-matched placebo plus mifepristone
daily risperidone-matched placebo plus mifepristone for 28 days

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
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 ( Coleman Gross )
Study ID Numbers: C-1073-205
Study First Received: June 12, 2008
Last Updated: February 2, 2009
ClinicalTrials.gov Identifier: NCT00698022     History of Changes
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

Study placed in the following topic categories:
Neurotransmitter Agents
Tranquilizing Agents
Contraceptive Agents
Hormone Antagonists
Contraceptives, Oral
Psychotropic Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Risperidone
Contraceptive Agents, Female
Central Nervous System Depressants
Mifepristone
Healthy
Contraceptives, Postcoital
Weight Gain
Antipsychotic Agents
Hormones
Serotonin
Body Weight
Signs and Symptoms
Dopamine
Weight Loss
Body Weight Changes
Dopamine Agents
Psychotic Disorders

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

ClinicalTrials.gov processed this record on May 07, 2009