SchizophreniaPhase 4NCT01185743
Antipsychotics and Gene Expression in Soft Tissues
A Phase 4 study testing olanzapine and ziprasidone in people with Schizophrenia and Diabetes, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Schizophrenia is a severe chronic and disabling mental disorder and is associated with a significant reduction in life expectancy. Atypical antipsychotic treatment compliance may be jeopardized because of drug induced weight gain and abnormalities in carbohydrate and lipid metabolism. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Diabetes
- What is being tested?
- olanzapine and ziprasidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2010to 1 Jan 2017
- Phase
- Phase 4
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male.
- Healthy, defined as absence of relevant diseases.
- Caucasian.
- Aged 18-45 years.
- Body-Mass-Index (BMI): 18-25 kg/m2.
- Signed informed consent.
- No signs of impaired glucose tolerance as evaluated by Oral Glucose Tolerance Test (OGTT) before study inclusion during screening, normal total cholesterol, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), triglycerides, normal function of the thyroid. No personal or family history (parents and siblings) of diabetes or other metabolic and relevant diseases as defined by the investigator.
- No indication for psychiatric diseases assessed by structured clinical interview (Mini-International Neuropsychiatric Interview (MINI)).
Who cannot join
- Personal or family history (parents and siblings) of diabetes or other metabolic diseases, relevant diseases as defined by the investigator.
- History of hypertension, blood pressure > 140/90 at screening, cardiovascular disease.
- Body mass index out of the range of <18 and >25 kg/m.
- Human immunodeficiency virus (HIV) or Hepatitis B/C positive virology.
- Allergy or hypersensitivity against olanzapine/ziprasidone or another excipient.
- Contraindications against the use of the drug according to the Summary of Product Characteristics (SmPC).
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- Any drug intake 2 weeks prior to first study day.
- History of excessive bleeding tendency/hemophilia.
- Presence of relevant illness within the last 3 weeks.
- Currently enrolled into an other clinical study with Investigational Medicinal Products (IMPs).
- Last study participation less than 4 weeks.
- Suspected non-compliance with study instructions and life-style requirements.
- History of alcohol or drug abuse.
- Blood/Plasma donation within 4 weeks prior to study day.
- Previous exposure to antipsychotic drugs.
- Nicotine consumption at time of enrolment (at least 3 months of non-smoking required).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Atypical Antipsychotics on Gene Expression in Soft Tissues of Healthy Subjects - A Placebo Controlled Randomised Pilot Study
Schizophrenia is a severe chronic and disabling mental disorder and is associated with a significant reduction in life expectancy. Atypical antipsychotic treatment compliance may be jeopardized because of drug induced weight gain and abnormalities in carbohydrate and lipid metabolism.
Aim: to gain data on drug related effects on gene expression and regulation with special regard to glucose metabolism.
- Conditions
- Schizophrenia, Diabetes
- Being tested
- olanzapine, ziprasidone, placebo
- Keywords
- healthy volunteers, antipsychotics, gene expression
- Medical subject headings
- Schizophrenia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olanzapineDrug
olanzapine 10mg od + placebo od
ziprasidoneDrug
ziprasidone 40mg td
placeboDrug
placebo td
| Study group | Role | What they receive |
|---|---|---|
| olanzapine | Active comparator | olanzapine Receives: Drug: olanzapine; Drug: ziprasidone |
| ziprasidone | Active comparator | ziprasidone Receives: Drug: olanzapine; Drug: ziprasidone |
| Sugar pill | Placebo comparator | Sugar pill Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
gene expression profiling
To characterize and compare the gene expression profiles in human subcutaneous adipose and muscle tissue prior and after single dose of olanzapine, ziprasidone and placebo.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2010 (estimated)
- Study startJul 2010
- Primary completion1 Jan 2017
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Bauer, Medical University of Vienna
- Investigators
- Martin Brunner, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185743
- Sponsor's protocol ID
- OLA_ZIPRA
- Status last verified
- Mar 2017
- First submitted
- 19 Aug 2010
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Atypical Antipsychotics on Gene Expression in Soft Tissues of Healthy Subjects - A Placebo Controlled Randomised Pilot Study
- ClinicalTrials.gov ID
- NCT01185743
- Acronym / sponsor ID
- OLA_ZIPRA
- Conditions
- Schizophrenia, Diabetes
- Keywords
- healthy volunteers, antipsychotics, gene expression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 20 Aug 2010 (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.
Schizophrenia is a severe chronic and disabling mental disorder and is associated with a significant reduction in life expectancy. Atypical antipsychotic treatment compliance may be jeopardized because of drug induced weight gain and abnormalities in carbohydrate and lipid metabolism.
Aim: to gain data on drug related effects on gene expression and regulation with special regard to glucose metabolism.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| olanzapine | Active comparator | Drug: olanzapine, Drug: ziprasidoneolanzapine |
| ziprasidone | Active comparator | Drug: olanzapine, Drug: ziprasidoneziprasidone |
| Sugar pill | Placebo comparator | Drug: placeboSugar pill |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male.
- Healthy, defined as absence of relevant diseases.
- Caucasian.
- Aged 18-45 years.
- Body-Mass-Index (BMI): 18-25 kg/m2.
Key exclusion criteria (16 listed)
- Personal or family history (parents and siblings) of diabetes or other metabolic diseases, relevant diseases as defined by the investigator.
- History of hypertension, blood pressure > 140/90 at screening, cardiovascular disease.
- Body mass index out of the range of <18 and >25 kg/m.
- Human immunodeficiency virus (HIV) or Hepatitis B/C positive virology.
- Allergy or hypersensitivity against olanzapine/ziprasidone or another excipient.
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 10mg od + placebo od | Drug | olanzapine, ziprasidone |
| ziprasidoneziprasidone 40mg td | Drug | olanzapine, ziprasidone |
| placeboplacebo td | Drug | Sugar pill |
Primary outcome
gene expression profiling
Time frame: 10 days
To characterize and compare the gene expression profiles in human subcutaneous adipose and muscle tissue prior and after single dose of olanzapine, ziprasidone and placebo.
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 23 Mar 2017.
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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.
Martin Brunner, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing olanzapine and ziprasidone in people with Schizophrenia and Diabetes, run by Medical University of Vienna at 1 site in Austria.
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 8 inclusion and 16 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 23 Mar 2017. 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 Austria. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
gene expression profiling (time frame: 10 days). 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 23 Mar 2017.