A Two-Week Study of the Efficacy and Safety of Mifepristone in the Prevention of Olanzapine-Induced Weight Gain

A Two-Week, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Mifepristone in the Prevention of Olanzapine-Induced Weight Gain in Healthy Male Volunteers

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00455442

Enrollment

Registered

2007-04-03

Start date

2007-03-31

Completion date

2007-07-31

Last updated

2008-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Weight-Gain Prevention

Brief summary

This is a two-week study testing the efficacy and safety of mifepristone in the prevention of olanzapine-induced weight gain in healthy male volunteers by measuring changes in body weight and BMI.

Interventions

DRUGMifepristone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male volunteers between 18 and 40 years of age * BMI between ≥ 18 and ≤ 25 * Able to provide written informed consent * Routine clinical laboratory tests either within normal limits or not clinically meaningful if outside of normal limits

Exclusion criteria

* History of Cushing's syndrome or Addison's disease * 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 non-prescribed drug of abuse (including but not limited to amphetamines, cannabinoids, barbiturates, cocaine, opiates, benzodiazepines) * 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 olanzapine * Any clinically significant abnormality on screening laboratory tests * QTc Bazzett's ≥ 450 msec * Any 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 * History of recent (within 6 months of screening) significant weight fluctuation

Design outcomes

Primary

Measure	Time frame
To determine the efficacy of mifepristone in the prevention of olanzapine-induced weight gain in healthy male volunteers.	—

Secondary

Measure	Time frame
To determine the tolerability and safety of the administration of mifepristone and olanzapine in healthy male volunteers.	—

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026