HealthyNCT01496183
Metabolic Effects of Olanzapine in Healthy Males
A study testing Olanzapine in people with Healthy, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The purpose of this study is to look at how a two-week use of a medication called Olanzapine might change appetite, physical activity, resting metabolic rate, body composition, and weight in healthy men. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Olanzapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Apr 2013
- Phase
- Interventional
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Volunteer
- Male
- Aged 18-35 years
- Body Mass Index (BMI): <30 kg/m2
Who cannot join
- Presence of any medical disorder that may confound the assessment of relevant biological measures
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Psychiatry, The State University of New York at Buffalo
Buffalo, New York, 14215
About this study
The purpose of this study is to look at how a two-week use of a medication called Olanzapine might change appetite, physical activity, resting metabolic rate, body composition, and weight in healthy men.
- Conditions
- Healthy
- Being tested
- Olanzapine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
PlaceboDrug
Placebo capsule administered orally at bedtime for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Olanzapine | Experimental | Not described Receives: Drug: Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Weight
Measured: Assessed at baseline and 2 weeks
Secondary outcomes (11)
Change From Baseline in Body Composition
lean body mass (kg) and fat mass (kg) at baseline and after 2 weeks of treatment with olanzapine or placebo
Measured: baseline and 2 weeks of treatment (olanzapine or placebo)
Change From Baseline in 24-Hour Dietary Recall
24-hour dietary intake recall at baseline and after 2 weeks of treatment with olanzapine or placebo
Measured: Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)
Change From Baseline in Resting Metabolic Rate
Resting metabolic rate at baseline and after 2 weeks of treatment
Measured: baseline and 2weeks of treatment
Change From Baseline Triglycerides
Triglycerides (mg/dl) at baseline and after 2 weeks of treatment with olanzapine or placebo
Measured: Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)
Change From Baseline in Glucose
Glucose (mg/dl) at baseline and after 2 weeks of treatment with olanzapine or placebo
Measured: Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)
Change From Baseline in Leptin
Leptin (ng/ml) at baseline and after 2 weeks of treatment with olanzapine or placebo
Measured: Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)
Change From Baseline in Insulin
Insulin (µIU/ml) at baseline and after 2 weeks of treatment with olanzapine or placebo
Measured: Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)
Change From Baseline Total Cholesterol
Total cholesterol at baseline and after 2 weeks treatment with olanzapine or placebo
Measured: baseline and 2 weeks treatment
LDL
Low-density lipoprotein at baseline and after 2 weeks of treatment with olanzapine or placebo
Measured: baseline and 2 weeks treatment
HDL
High-density lipoprotein at baseline and after 2 weeks of treatment with olanzapine or placebo
Measured: baseline and 2 weeks treatment
Physical Activity as Measured Using a Physical Activity Monitor
Change from baseline in physical activity. Physical activity was measured using an activity monitor that subjects wore around their waist throughout baseline and treatment days. Subjects were instructed to remove the monitor when sleeping or engaging in water-based activities, and to report on a daily log the times that they were wearing and removing the device. Physical activity was monitored during weekdays and weekend days. Physical activity data were collected in 60-second epochs. The results are reported as average counts per day of physical activity for weekdays and weekend days at baseline and 2 week treatment.
Measured: baseline and 2 week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study startOct 2007
- Primary completionApr 2013
- Study completionApr 2013
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.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Dubovsky, State University of New York at Buffalo
- Investigators
- Steven L Dubovsky, M.D., Principal investigator, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496183
- Sponsor's protocol ID
- PCH0320106A
- Status last verified
- Jul 2018
- First submitted
- 13 Dec 2011
- Last updated
- 16 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Olanzapine in Healthy Males
- ClinicalTrials.gov ID
- NCT01496183
- Acronym / sponsor ID
- PCH0320106A
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 21 Dec 2011 (estimated)
- Results
- Posted 1 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to look at how a two-week use of a medication called Olanzapine might change appetite, physical activity, resting metabolic rate, body composition, and weight in healthy men.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Olanzapine | Experimental | Drug: Olanzapine |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy Volunteer
- Male
- Aged 18-35 years
- Body Mass Index (BMI): <30 kg/m2
Key exclusion criteria (1 listed)
- Presence of any medical disorder that may confound the assessment of relevant biological measures
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 |
|---|---|---|
| OlanzapineOlanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days. | Drug | Olanzapine |
| PlaceboPlacebo capsule administered orally at bedtime for 14 days | Drug | Placebo |
Primary outcome
Change From Baseline in Weight
Time frame: Assessed at baseline and 2 weeks
11 secondary outcomes
Change From Baseline in Body Composition
Time frame: baseline and 2 weeks of treatment (olanzapine or placebo)
Change From Baseline in 24-Hour Dietary Recall
Time frame: Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)
Change From Baseline in Resting Metabolic Rate
Time frame: baseline and 2weeks of treatment
Change From Baseline Triglycerides
Time frame: Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)
Change From Baseline in Glucose
Time frame: Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)
Change From Baseline in Leptin
Time frame: Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)
Change From Baseline in Insulin
Time frame: Assessed at different time points: baseline and 2 weeks of treatment (olanzapine or placebo)
Change From Baseline Total Cholesterol
Time frame: baseline and 2 weeks treatment
LDL
Time frame: baseline and 2 weeks treatment
HDL
Time frame: baseline and 2 weeks treatment
Physical Activity as Measured Using a Physical Activity Monitor
Time frame: baseline and 2 week treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Steven L Dubovsky, M.D. principal investigator
State University of New York at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Olanzapine in people with Healthy, run by State University of New York at Buffalo at 1 site in United States.
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 1 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 16 Aug 2018. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Dec 2014). 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 Weight (time frame: Assessed at baseline and 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2018.