HealthyPhase 1NCT00698022
A 4-week Study of Mifepristone in the Prevention of Risperidone-induced Weight Gain in Healthy Male Volunteers
A Phase 1 study testing Risperidone and Mifepristone in people with Healthy, run by Corcept Therapeutics at 1 site in India.
Trial summary
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. 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
- Healthy
- What is being tested?
- Risperidone and Mifepristone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2008to Feb 2009
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Risperidone, Mifepristone, Risperidone-matched placebo, Mifepristone-matched placebo
- Keywords
- healthy, weight gain, anti-psychotic, risperidone, mifepristone, mitigation, weight loss
- Medical subject headings
- Weight Gain, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
Also called Risperdal
risperidone daily for 28 days
MifepristoneDrug
Also called Corlux
mifepristone daily for 28 days
Risperidone-matched placeboDrug
risperidone-matched placebo daily for 28 days
Mifepristone-matched placeboDrug
mifepristone-matched placebo daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Risperidone plus mifepristone | Experimental | risperidone plus mifepristone daily for 28 days Receives: Drug: Risperidone; Drug: Mifepristone |
| Risperidone plus mifepristone-matched placebo | Placebo comparator | risperidone plus mifepristone-matched placebo daily for 28 days Receives: Drug: Risperidone; Drug: Mifepristone-matched placebo |
| Risperidone-matched placebo plus mifepristone | Placebo comparator | risperidone-matched placebo plus mifepristone daily for 28 days Receives: Drug: Mifepristone; Drug: Risperidone-matched placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Body Weight
Measured: Baseline and 28 days
Secondary outcomes (3)
Percentage of Participants With <5% and <7% Increase From Baseline in Body Weight
Measured: Baseline and 28 days
Percentage of Participants With One or More Adverse Events
Measured: Up to 28 days
Percentage of Participants Discontinued From the Study Due to an Adverse Event
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2008 (estimated)
- Study startNov 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Coleman Gross, MD, Study director, Corcept Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698022
- Sponsor's protocol ID
- C-1073-205
- Status last verified
- Feb 2022
- First submitted
- 12 Jun 2008
- Last updated
- 8 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00698022
- Acronym / sponsor ID
- C-1073-205
- Conditions
- Healthy
- Keywords
- healthy, weight gain, anti-psychotic, risperidone, mifepristone, mitigation, weight loss
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 16 Jun 2008 (estimated)
- Results
- Posted 4 May 2012
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 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Risperidone plus mifepristone | Experimental | Drug: Risperidone, Drug: Mifepristonerisperidone plus mifepristone daily for 28 days |
| Risperidone plus mifepristone-matched placebo | Placebo comparator | Drug: Risperidone, Drug: Mifepristone-matched placeborisperidone plus mifepristone-matched placebo daily for 28 days |
| Risperidone-matched placebo plus mifepristone | Placebo comparator | Drug: Mifepristone, Drug: Risperidone-matched placeborisperidone-matched placebo plus mifepristone daily for 28 days |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| RisperidoneAlso: Risperdalrisperidone daily for 28 days | Drug | Risperidone plus mifepristone, Risperidone plus mifepristone-matched placebo |
| MifepristoneAlso: Corluxmifepristone daily for 28 days | Drug | Risperidone plus mifepristone, Risperidone-matched placebo plus mifepristone |
| Risperidone-matched placeborisperidone-matched placebo daily for 28 days | Drug | Risperidone-matched placebo plus mifepristone |
| Mifepristone-matched placebomifepristone-matched placebo daily for 28 days | Drug | Risperidone plus mifepristone-matched placebo |
Primary outcome
Change From Baseline in Body Weight
Time frame: Baseline and 28 days
3 secondary outcomes
Percentage of Participants With <5% and <7% Increase From Baseline in Body Weight
Time frame: Baseline and 28 days
Percentage of Participants With One or More Adverse Events
Time frame: Up to 28 days
Percentage of Participants Discontinued From the Study Due to an Adverse Event
Time frame: Up to 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- Sponsor's 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.
Coleman Gross, 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 1 study testing Risperidone and Mifepristone in people with Healthy, 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 7 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 8 Feb 2022. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Body Weight (time frame: Baseline and 28 days). 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 NCT00698022, 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 8 Feb 2022.