- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00290121
Appetite Increase in Schizophrenia Patients Treated With Atypical Antipsychotics
Cerebral Mechanism Involved in Appetite Increase in Schizophrenia Patients Treated With Atypical Antipsychotics (IIT)
Study Overview
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 Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Quebec
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Montréal, Quebec, Canada, H1N 3V2
- Centre de recherche Fernand-Seguin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- concomitant axis-I or axis-II disorders
- unstable medical condition
- Concomitant antipsychotic medications
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Olanzapine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
fMRI (functional magnetic resonance imaging with appetizing films)
Time Frame: 16 weeks after beginning of Olanzapine treatment
|
16 weeks after beginning of Olanzapine treatment
|
Weight
Time Frame: 16 weeks after beginning of Olanzapine treatment
|
16 weeks after beginning of Olanzapine treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Weight
Time Frame: 16 weeks after beginning of Olanzapine treatment
|
16 weeks after beginning of Olanzapine treatment
|
Fasting glucose
Time Frame: 16 weeks after beginning of Olanzapine treatment
|
16 weeks after beginning of Olanzapine treatment
|
Insulin
Time Frame: 16 weeks after beginning of Olanzapine treatment
|
16 weeks after beginning of Olanzapine treatment
|
Leptin
Time Frame: 16 weeks after beginning of Olanzapine treatment
|
16 weeks after beginning of Olanzapine treatment
|
Ghrelin
Time Frame: 16 weeks after beginning of Olanzapine treatment
|
16 weeks after beginning of Olanzapine treatment
|
Endogenous cannabinoids
Time Frame: 16 weeks after beginning of Olanzapine treatment
|
16 weeks after beginning of Olanzapine treatment
|
Lipid profile
Time Frame: 16 weeks after beginning of Olanzapine treatment
|
16 weeks after beginning of Olanzapine treatment
|
PANSS (Positive and negative syndrome scale)
Time Frame: 16 weeks after beginning of Olanzapine treatment
|
16 weeks after beginning of Olanzapine treatment
|
CDSS (Calgary Depression scale for schizophrenia)
Time Frame: 16 weeks after beginning of Olanzapine treatment
|
16 weeks after beginning of Olanzapine treatment
|
Three factors eating questionnaire
Time Frame: 16 weeks after beginning of Olanzapine treatment
|
16 weeks after beginning of Olanzapine treatment
|
Fagerstrom test for nicotine dependence
Time Frame: 16 weeks after beginning of Olanzapine treatment
|
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
|
16 weeks after beginning of Olanzapine treatment
|
Age
Time Frame: 16 weeks after beginning of Olanzapine treatment
|
16 weeks after beginning of Olanzapine treatment
|
Sexe
Time Frame: 16 weeks after beginning of Olanzapine treatment
|
16 weeks after beginning of Olanzapine treatment
|
Abdominal circumference
Time Frame: 16 weeks after beginning of Olanzapine treatment
|
16 weeks after beginning of Olanzapine treatment
|
Number and times of hospitalization
Time Frame: 16 weeks after beginning of Olanzapine treatment
|
16 weeks after beginning of Olanzapine treatment
|
Blood pressure
Time Frame: 16 weeks after beginning of Olanzapine treatment
|
16 weeks after beginning of Olanzapine treatment
|
Prolactin
Time Frame: 16 weeks after beginning of Olanzapine treatment
|
16 weeks after beginning of Olanzapine treatment
|
Onset of disease
Time Frame: 16 weeks after beginning of Olanzapine treatment
|
16 weeks after beginning of Olanzapine treatment
|
Level of education
Time Frame: 16 weeks after beginning of Olanzapine treatment
|
16 weeks after beginning of Olanzapine treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Emmanuel Stip, MD, M.Sc., Centre de recherche Fernand-Seguin, Université de Montréal
Publications and helpful links
General 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.
- Stip 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.
- Stip 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Olanzapine
Other Study ID Numbers
- 2005-0503
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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