Weight-Gain PreventionPhase 2NCT00455442
A Two-Week Study of the Efficacy and Safety of Mifepristone in the Prevention of Olanzapine-Induced Weight Gain
A Phase 2 study testing Mifepristone in people with Weight-Gain Prevention, run by Corcept Therapeutics at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Weight-Gain Prevention
- What is being tested?
- Mifepristone
- How many people
- 57 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2007to Jul 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Weight-Gain Prevention
- Being tested
- Mifepristone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MifepristoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the efficacy of mifepristone in the prevention of olanzapine-induced weight gain in healthy male volunteers.
Secondary outcomes (1)
To determine the tolerability and safety of the administration of mifepristone and olanzapine in healthy male volunteers.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2007 (estimated)
- Study startMar 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight-Gain PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Investigators
- Thad Block, MD, Study director, Corcept Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00455442
- Sponsor's protocol ID
- C-1073-200
- Status last verified
- Sep 2008
- First submitted
- 30 Mar 2007
- Last updated
- 19 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Beebe KL, Block T, Debattista C, Blasey C, Belanoff JK. The efficacy of mifepristone in the reduction and prevention of olanzapine-induced weight gain in rats. Behav Brain Res. 2006 Aug 10;171(2):225-9. doi: 10.1016/j.bbr.2006.03.039. Epub 2006 Jun 19.
PubMed 16782211
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00455442
- Acronym / sponsor ID
- C-1073-200
- Conditions
- Weight-Gain Prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Eli Lilly and Company
- Study start
- Mar 2007
- Study completion
- Jul 2007 (actual)
- First posted
- 3 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mifepristone | Drug | – |
Primary outcome
To determine the efficacy of mifepristone in the prevention of olanzapine-induced weight gain in healthy male volunteers.
1 secondary outcome
To determine the tolerability and safety of the administration of mifepristone and olanzapine in healthy male volunteers.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2008.
- Background: PubMed 16782211Beebe KL, Block T, Debattista C, Blasey C, Belanoff JK. The efficacy of mifepristone in the reduction and prevention of olanzapine-induced weight gain in rats. Behav Brain Res. 2006 Aug 10;171(2):225-9. doi: 10.1016/j.bbr.2006.03.039. Epub 2006 Jun 19.
- Corcept Therapeutics official websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thad Block, MD study director
Corcept Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mifepristone in people with Weight-Gain Prevention, run by Corcept Therapeutics at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the efficacy of mifepristone in the prevention of olanzapine-induced weight gain in healthy male volunteers.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00455442, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2008.