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Sponsored by: |
Corcept Therapeutics |
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Information provided by: | Corcept Therapeutics |
ClinicalTrials.gov Identifier: | NCT00698022 |
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 |
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 |
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 |
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1: Experimental |
Drug: risperidone plus mifepristone
daily risperidone plus mifepristone for 28 days
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2: Placebo Comparator
risperidone plus mifepristone-matched placebo
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Drug: risperidone plus placebo
daily risperidone plus placebo for 28 days
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3: Placebo Comparator
risperidone-matched placebo plus mifepristone
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Drug: risperidone-matched placebo plus mifepristone
daily risperidone-matched placebo plus mifepristone for 28 days
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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.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
healthy weight gain anti-psychotic risperidone |
mifepristone mitigation weight loss |
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 |
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 |