SchizophreniaPhase 4NCT00290121
Appetite Increase in Schizophrenia Patients Treated With Atypical Antipsychotics
A Phase 4 study testing Olanzapine in people with Schizophrenia, run by Université de Montréal at 1 site in Canada.
Trial summary
The purpose of this study is to understand, with the use of functional magnetic resonance imaging, the neural correlates involved in appetite control and the mechanism of weight gain in patients with schizophrenia treated with atypical antipsychotics. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Olanzapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2006to Jun 2008
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with schizophrenia (DMS-IV)
- 18 to 60 years old
- Right handed
- Begin a treatment with olanzapine and had not received it for at leat 6 months
- Other medication accepted (except antipsychotic)
Who cannot join
- concomitant axis-I or axis-II disorders
- unstable medical condition
- Concomitant antipsychotic medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cerebral Mechanism Involved in Appetite Increase in Schizophrenia Patients Treated With Atypical Antipsychotics (IIT)
The purpose of this study is to understand, with the use of functional magnetic resonance imaging, the neural correlates involved in appetite control and the mechanism of weight gain in patients with schizophrenia treated with atypical antipsychotics. We hypothesize that a difference in cerebral activations between weight gaining and non-weight gaining patients will be detected after four months of treatment with olanzapine.
Read the detailed description
Atypical antipsychotics (AAP) have revolutionize treatment of schizophrenia. They are considered to be more effective in reducing positive and negative symptoms and in improving cognitive deficits. They cause less extrapyramidal symptoms and tardive dyskinesia than typical antipsychotics. They still have a lot of important side effects like sedation, metabolic syndrome and weight gain. These effects could lead to obesity, type II diabetes and cardiovascular diseases, particularly for schizophrenia patients because they are already at an increased risk for these complications. Moreover, an increase in weight gain has been demonstrate to exacerbate negative symptoms and can lead to non compliance with a consequent risk of relapse. It also can create an additional social disadvantage for schizophrenia patients and decrease their quality of life. The weight gain will result, in part from an increased food intake (and probably an increased appetite) and from a decreased energy expenditure.
The purpose of this study is to understand the cerebral mechanisms of appetite in patients with schizophrenia treated with atypical antipsychotics to prevent or treat their weight gain.
- Conditions
- Schizophrenia
- Being tested
- Olanzapine
- Keywords
- Schizophrenia, Atypical antipsychotics, Weight gain, Appetite, fMRI
- Medical subject headings
- Schizophrenia, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
| Study group | Role | What they receive |
|---|---|---|
| Olanzapine | Active comparator | Not described Receives: Drug: Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI (functional magnetic resonance imaging with appetizing films)
Measured: 16 weeks after beginning of Olanzapine treatment
Weight
Measured: 16 weeks after beginning of Olanzapine treatment
Secondary outcomes (20)
Fasting glucose
Measured: 16 weeks after beginning of Olanzapine treatment
Insulin
Measured: 16 weeks after beginning of Olanzapine treatment
Leptin
Measured: 16 weeks after beginning of Olanzapine treatment
Ghrelin
Measured: 16 weeks after beginning of Olanzapine treatment
Endogenous cannabinoids
Measured: 16 weeks after beginning of Olanzapine treatment
Lipid profile
Measured: 16 weeks after beginning of Olanzapine treatment
PANSS (Positive and negative syndrome scale)
Measured: 16 weeks after beginning of Olanzapine treatment
CDSS (Calgary Depression scale for schizophrenia)
Measured: 16 weeks after beginning of Olanzapine treatment
Three factors eating questionnaire
Measured: 16 weeks after beginning of Olanzapine treatment
Fagerstrom test for nicotine dependence
Measured: 16 weeks after beginning of Olanzapine treatment
Adult ADHD (attention deficit hyperactivity disorder) self report scale
Measured: 16 weeks after beginning of Olanzapine treatment
Age
Measured: 16 weeks after beginning of Olanzapine treatment
Sexe
Measured: 16 weeks after beginning of Olanzapine treatment
Weight
Measured: 16 weeks after beginning of Olanzapine treatment
Abdominal circumference
Measured: 16 weeks after beginning of Olanzapine treatment
Number and times of hospitalization
Measured: 16 weeks after beginning of Olanzapine treatment
Blood pressure
Measured: 16 weeks after beginning of Olanzapine treatment
Prolactin
Measured: 16 weeks after beginning of Olanzapine treatment
Onset of disease
Measured: 16 weeks after beginning of Olanzapine treatment
Level of education
Measured: 16 weeks after beginning of Olanzapine treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2006 (estimated)
- Study startSep 2006
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal, Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Emmanuel Stip, MD, M.Sc., Principal investigator, Centre de recherche Fernand-Seguin, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00290121
- Sponsor's protocol ID
- 2005-0503
- Status last verified
- Oct 2005
- First submitted
- 8 Feb 2006
- Last updated
- 14 Mar 2013
- Results posted
- No
Publications
Orban P, Desseilles M, Mendrek A, Bourque J, Bellec P, Stip E. Altered brain connectivity in patients with schizophrenia is consistent across cognitive contexts. J Psychiatry Neurosci. 2017 Jan;42(1):17-26. doi: 10.1503/jpn.150247.
PubMed 27091719Stip E, Lungu OV. Salience network and olanzapine in schizophrenia: implications for treatment in anorexia nervosa. Can J Psychiatry. 2015 Mar;60(3 Suppl 2):S35-9.
PubMed 25886678Stip E, Lungu OV, Anselmo K, Letourneau G, Mendrek A, Stip B, Lipp O, Lalonde P, Bentaleb LA. Neural changes associated with appetite information processing in schizophrenic patients after 16 weeks of olanzapine treatment. Transl Psychiatry. 2012 Jun 19;2(6):e128. doi: 10.1038/tp.2012.53.
PubMed 22714121
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Mechanism Involved in Appetite Increase in Schizophrenia Patients Treated With Atypical Antipsychotics (IIT)
- ClinicalTrials.gov ID
- NCT00290121
- Acronym / sponsor ID
- 2005-0503
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Atypical antipsychotics, Weight gain, Appetite, fMRI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Collaborators
- Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal, Eli Lilly and Company
- Study start
- Sep 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 10 Feb 2006 (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.
The purpose of this study is to understand, with the use of functional magnetic resonance imaging, the neural correlates involved in appetite control and the mechanism of weight gain in patients with schizophrenia treated with atypical antipsychotics. We hypothesize that a difference in cerebral activations between weight gaining and non-weight gaining patients will be detected after four months of treatment with olanzapine.
Detailed description
Atypical antipsychotics (AAP) have revolutionize treatment of schizophrenia. They are considered to be more effective in reducing positive and negative symptoms and in improving cognitive deficits. They cause less extrapyramidal symptoms and tardive dyskinesia than typical antipsychotics. They still have a lot of important side effects like sedation, metabolic syndrome and weight gain. These effects could lead to obesity, type II diabetes and cardiovascular diseases, particularly for schizophrenia patients because they are already at an increased risk for these complications. Moreover, an increase in weight gain has been demonstrate to exacerbate negative symptoms and can lead to non compliance with a consequent risk of relapse. It also can create an additional social disadvantage for schizophrenia patients and decrease their quality of life. The weight gain will result, in part from an increased food intake (and probably an increased appetite) and from a decreased energy expenditure.
The purpose of this study is to understand the cerebral mechanisms of appetite in patients with schizophrenia treated with atypical antipsychotics to prevent or treat their weight gain.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Olanzapine | Active comparator | Drug: Olanzapine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with schizophrenia (DMS-IV)
- 18 to 60 years old
- Right handed
- Begin a treatment with olanzapine and had not received it for at leat 6 months
- Other medication accepted (except antipsychotic)
Key exclusion criteria (3 listed)
- concomitant axis-I or axis-II disorders
- unstable medical condition
- Concomitant antipsychotic medications
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 | Drug | Olanzapine |
Primary outcome
fMRI (functional magnetic resonance imaging with appetizing films)
Time frame: 16 weeks after beginning of Olanzapine treatment
Weight
Time frame: 16 weeks after beginning of Olanzapine treatment
20 secondary outcomes
Fasting glucose
Time frame: 16 weeks after beginning of Olanzapine treatment
Insulin
Time frame: 16 weeks after beginning of Olanzapine treatment
Leptin
Time frame: 16 weeks after beginning of Olanzapine treatment
Ghrelin
Time frame: 16 weeks after beginning of Olanzapine treatment
Endogenous cannabinoids
Time frame: 16 weeks after beginning of Olanzapine treatment
Lipid profile
Time frame: 16 weeks after beginning of Olanzapine treatment
PANSS (Positive and negative syndrome scale)
Time frame: 16 weeks after beginning of Olanzapine treatment
CDSS (Calgary Depression scale for schizophrenia)
Time frame: 16 weeks after beginning of Olanzapine treatment
Three factors eating questionnaire
Time frame: 16 weeks after beginning of Olanzapine treatment
Fagerstrom test for nicotine dependence
Time frame: 16 weeks after beginning of Olanzapine treatment
Adult ADHD (attention deficit hyperactivity disorder) self report scale
Time frame: 16 weeks after beginning of Olanzapine treatment
Age
Time frame: 16 weeks after beginning of Olanzapine treatment
Sexe
Time frame: 16 weeks after beginning of Olanzapine treatment
Weight
Time frame: 16 weeks after beginning of Olanzapine treatment
Abdominal circumference
Time frame: 16 weeks after beginning of Olanzapine treatment
Number and times of hospitalization
Time frame: 16 weeks after beginning of Olanzapine treatment
Blood pressure
Time frame: 16 weeks after beginning of Olanzapine treatment
Prolactin
Time frame: 16 weeks after beginning of Olanzapine treatment
Onset of disease
Time frame: 16 weeks after beginning of Olanzapine treatment
Level of education
Time frame: 16 weeks after beginning of Olanzapine treatment
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 14 Mar 2013.
- Derived from this study: PubMed 27091719Orban P, Desseilles M, Mendrek A, Bourque J, Bellec P, Stip E. Altered brain connectivity in patients with schizophrenia is consistent across cognitive contexts. J Psychiatry Neurosci. 2017 Jan;42(1):17-26. doi: 10.1503/jpn.150247.
- Derived from this study: PubMed 25886678Stip E, Lungu OV. Salience network and olanzapine in schizophrenia: implications for treatment in anorexia nervosa. Can J Psychiatry. 2015 Mar;60(3 Suppl 2):S35-9.
- Derived from this study: PubMed 22714121Stip E, Lungu OV, Anselmo K, Letourneau G, Mendrek A, Stip B, Lipp O, Lalonde P, Bentaleb LA. Neural changes associated with appetite information processing in schizophrenic patients after 16 weeks of olanzapine treatment. Transl Psychiatry. 2012 Jun 19;2(6):e128. doi: 10.1038/tp.2012.53.
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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.
Emmanuel Stip, MD, M.Sc. principal investigator
Centre de recherche Fernand-Seguin, Université de Montréal
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 in people with Schizophrenia, run by Université de Montréal 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 3 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 14 Mar 2013. 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. 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?
fMRI (functional magnetic resonance imaging with appetizing films) (time frame: 16 weeks after beginning of Olanzapine treatment). 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?
On the ClinicalTrials.gov record for NCT00290121, which also lists 3 linked publications.
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 14 Mar 2013.