HealthyPhase 2/3OLANCT04181385
Acute Olanzapine and Lipid Response
A Phase 2/3 study testing Olanzapine 10 milligram and Bromocriptine 5 milligram in people with Healthy, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Atypical antipsychotics are pharmaceutical drugs used to treat schizophrenia. Common side effects are weight gain, insulin resistance, and abnormal blood lipids. This increases the risk for type 2 diabetes and cardiovascular disease in patients taking these drugs. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Olanzapine 10 milligram and Bromocriptine 5 milligram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2019to 1 Jun 2020
- Phase
- Phase 2/3
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women, aged 18 to 60 years
- Body mass index (BMI) 20 to 40 kg/m2
- Hemoglobin in the normal range.
- Normal glucose tolerance in response to a 75 gram, 2-hr oral glucose tolerance test
- Women of reproductive age should be on contraception (oral contraceptive pill or intra-uterine device/coil) for at least 2 months prior to and after the study. Anyone with a positive urine pregnancy test (carried out at screening and the day before each kinetic study) will be excluded.
Who cannot join
- Any volunteer with evidence of prolonged corrected QT interval (>470 ms in males and >450ms in females)
- Any volunteer with morbid obesity (BMI>40 or BMI>30 with any obesity related medical complication such as diabetes, hypertension or coronary disease)
- Any history of a myocardial infarction or clinically significant, active, cardiovascular history including a history of arrhythmia's or conduction delays on echocardiogram, unstable angina, or decompensated heart failure
- Study participant with a history of hepatic disease that has been active within the previous two years.
- Any current or previous history of biliary disease (including gall stones, biliary atresia and cholecystitis) or pancreatitis.
- Any current or previous history of endocrine disease, dyslipidemia or malignancy
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- Any significant active (over the past 12 months) disease of the gastrointestinal, pulmonary, neurological, renal (Cr > 1.5 mg/dL) genitourinary, hematological systems, or has severe uncontrolled treated or untreated hyper/ hypotension (sitting diastolic BP > 100 or systolic > 180 or systolic BP<100) or proliferative retinopathy
- Use of immunosuppressive agents at any time during the study
- Allergy to any study medication
- Pregnancy (as ascertained by urinary human chorionic gonadotropin at screening and the day before each study visit) or breastfeeding
- Fasting blood glucose > 6.0 mmol/l or known diabetes.
- Any laboratory values: aspartate aminotransferase > 2x upper limit of normal (ULN); alanine transaminase >2x ULN thyroid stimulating hormone > 6 mU/l
- Current addiction to alcohol or substances of abuse as determined by the investigator or of any mental illness.
- Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation
- Taking any regular prescription or non-prescription medications at the time of the study. Occasional use of medications such as acetaminophen or Tylenol 1 or any use of natural health products may be permitted at the discretion of the investigator.
- Will not donate blood three months prior to and three months post study procedures
- Hemoglobin below the reference range (less than 130 g/l for males and 120 g/l for females) based on blood tests at screening and on the day before the kinetic study
- Hematocrit below the reference range (less than 0.38 for males and 0.37 for females) based on blood tests at screening and on the day before the kinetic study
- Soy allergy (component of high-fat drink)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Priska Stahel, PhD, 416-581-7487, priska.stahel@uhn.ca
Satya Dash, MD, 416-340-4800 ext. 8094, satya.dash@uhn.ca
About this study
Official title: Assessment of Lipid Response to Acute Olanzapine in Healthy Adults
Atypical antipsychotics are pharmaceutical drugs used to treat schizophrenia. Common side effects are weight gain, insulin resistance, and abnormal blood lipids. This increases the risk for type 2 diabetes and cardiovascular disease in patients taking these drugs. In particular, olanzapine is a highly effective therapy for schizophrenia but is commonly associated with metabolic disturbances. It has previously been shown that the negative effects on insulin sensitivity and glucose metabolism occur even after a single dose, independently of weight gain. These effects may be mediated by blocking the dopamine (D2) receptor. In this study the research team is investigating whether a single dose of olanzapine alters postprandial lipid metabolism after a high-fat drink. Olanzapine administered along with the high-fat drink will be compared to placebo or olanzapine plus bromocriptine (an activator of the D2 receptor).
Read the detailed description
Postprandial lipid and hormonal responses are being investigated in up to 15 individuals. Participants are their own control in a single-blind, placebo-controlled, crossover design. Participants are admitted after an overnight fast. Participants will consume a high-fat drink (50g of fat) along with either oral placebo, olanzapine (10mg) or olanzapine (10mg) plus bromocriptine (5mg). Study visits occur 2-4 weeks apart with the three treatments applied in random order. Blood samples will be taken at baseline and regular intervals after the treatments for up to 8 hours to measure glucose, insulin, triglycerides, fatty acids and other hormones/metabolites.
- Conditions
- Healthy
- Being tested
- Olanzapine 10 milligram, Bromocriptine 5 milligram, Placebo oral tablet
- Keywords
- olanzapine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olanzapine 10 milligramDrug
Oral olanzapine capsule
Bromocriptine 5 milligramDrug
Oral bromocriptine capsule
Placebo oral tabletDrug
oral placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Olanzapine | Experimental | Olanzapine, 10mg, oral, single dose Receives: Drug: Olanzapine 10 milligram |
| Olanzapine plus bromocriptine | Experimental | Olanzapine, 10mg, oral, single dose Bromocriptine, 5mg, oral, single dose Receives: Drug: Olanzapine 10 milligram; Drug: Bromocriptine 5 milligram |
| Placebo | Placebo comparator | Placebo, oral, single dose Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma triglycerides
Plasma triglycerides measured after treatments
Measured: 8 hours
Plasma fatty acids
Plasma fatty acids measured after treatments
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start1 Jan 2019
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 2/3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants receive either placebo, olanzapine or olanzapine plus bromocriptine, in random order on 3 separate study visits, with blood samples taken before and after treatment and intake of a high-fat drink
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Satya Dash, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181385
- Sponsor's protocol ID
- OLA 15-8951
- Acronym
- OLA
- Status last verified
- Nov 2019
- First submitted
- 25 Nov 2019
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Lipid Response to Acute Olanzapine in Healthy Adults
- ClinicalTrials.gov ID
- NCT04181385
- Acronym / sponsor ID
- OLA / OLA 15-8951
- Conditions
- Healthy
- Keywords
- olanzapine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 29 Nov 2019 (actual)
- 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.
Atypical antipsychotics are pharmaceutical drugs used to treat schizophrenia. Common side effects are weight gain, insulin resistance, and abnormal blood lipids. This increases the risk for type 2 diabetes and cardiovascular disease in patients taking these drugs. In particular, olanzapine is a highly effective therapy for schizophrenia but is commonly associated with metabolic disturbances. It has previously been shown that the negative effects on insulin sensitivity and glucose metabolism occur even after a single dose, independently of weight gain. These effects may be mediated by blocking the dopamine (D2) receptor. In this study the research team is investigating whether a single dose of olanzapine alters postprandial lipid metabolism after a high-fat drink. Olanzapine administered along with the high-fat drink will be compared to placebo or olanzapine plus bromocriptine (an activator of the D2 receptor).
Detailed description
Postprandial lipid and hormonal responses are being investigated in up to 15 individuals. Participants are their own control in a single-blind, placebo-controlled, crossover design. Participants are admitted after an overnight fast. Participants will consume a high-fat drink (50g of fat) along with either oral placebo, olanzapine (10mg) or olanzapine (10mg) plus bromocriptine (5mg). Study visits occur 2-4 weeks apart with the three treatments applied in random order. Blood samples will be taken at baseline and regular intervals after the treatments for up to 8 hours to measure glucose, insulin, triglycerides, fatty acids and other hormones/metabolites.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants receive either placebo, olanzapine or olanzapine plus bromocriptine, in random order on 3 separate study visits, with blood samples taken before and after treatment and intake of a high-fat drink
| Arm | Type | Receives |
|---|---|---|
| Olanzapine | Experimental | Drug: Olanzapine 10 milligramOlanzapine, 10mg, oral, single dose |
| Olanzapine plus bromocriptine | Experimental | Drug: Olanzapine 10 milligram, Drug: Bromocriptine 5 milligramOlanzapine, 10mg, oral, single dose Bromocriptine, 5mg, oral, single dose |
| Placebo | Placebo comparator | Drug: Placebo oral tabletPlacebo, oral, single dose |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men and women, aged 18 to 60 years
- Body mass index (BMI) 20 to 40 kg/m2
- Hemoglobin in the normal range.
- Normal glucose tolerance in response to a 75 gram, 2-hr oral glucose tolerance test
- Women of reproductive age should be on contraception (oral contraceptive pill or intra-uterine device/coil) for at least 2 months prior to and after the study. Anyone with a positive urine pregnancy test (carried out at screening and the day before each kinetic study) will be excluded.
Key exclusion criteria (19 listed)
- Any volunteer with evidence of prolonged corrected QT interval (>470 ms in males and >450ms in females)
- Any volunteer with morbid obesity (BMI>40 or BMI>30 with any obesity related medical complication such as diabetes, hypertension or coronary disease)
- Any history of a myocardial infarction or clinically significant, active, cardiovascular history including a history of arrhythmia's or conduction delays on echocardiogram, unstable angina, or decompensated heart failure
- Study participant with a history of hepatic disease that has been active within the previous two years.
- Any current or previous history of biliary disease (including gall stones, biliary atresia and cholecystitis) or pancreatitis.
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 |
|---|---|---|
| Olanzapine 10 milligramOral olanzapine capsule | Drug | Olanzapine, Olanzapine plus bromocriptine |
| Bromocriptine 5 milligramOral bromocriptine capsule | Drug | Olanzapine plus bromocriptine |
| Placebo oral tabletoral placebo capsules | Drug | Placebo |
Primary outcome
Plasma triglycerides
Time frame: 8 hours
Plasma triglycerides measured after treatments
Plasma fatty acids
Time frame: 8 hours
Plasma fatty acids measured after treatments
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2019.
- Individual participant dataSharing planned: No
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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.
Satya Dash, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Olanzapine 10 milligram and Bromocriptine 5 milligram in people with Healthy, run by University Health Network, Toronto at 1 site in Canada.
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 5 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 3 Dec 2019. 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 Canada. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Priska Stahel, PhD (416-581-7487, priska.stahel@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma triglycerides (time frame: 8 hours). The study lists 2 primary outcomes in all. 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 3 Dec 2019.