Appetite Increase in Schizophrenia Patients Treated With Atypical Antipsychotics
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Olanzapine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Cerebral Mechanism Involved in Appetite Increase in Schizophrenia Patients Treated With Atypical Antipsychotics (IIT) |
- fMRI (functional magnetic resonance imaging with appetizing films) [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
- Weight [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
- Fasting glucose [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
- Insulin [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
- Leptin [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
- Ghrelin [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
- Endogenous cannabinoids [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
- Lipid profile [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
- PANSS (Positive and negative syndrome scale) [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
- CDSS (Calgary Depression scale for schizophrenia) [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
- Three factors eating questionnaire [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
- Fagerstrom test for nicotine dependence [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
- Adult ADHD (attention deficit hyperactivity disorder) self report scale [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
- Age [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
- Sexe [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
- Weight [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
- Abdominal circumference [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
- Number and times of hospitalization [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
- Blood pressure [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
- Prolactin [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
- Onset of disease [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
- Level of education [ Time Frame: 16 weeks after beginning of Olanzapine treatment ] [ Designated as safety issue: No ]
| Enrollment: | 25 |
| Study Start Date: | September 2006 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Olanzapine | Drug: 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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Canada, Quebec | |
| Centre de recherche Fernand-Seguin | |
| Montréal, Quebec, Canada, H1N 3V2 | |
| Principal Investigator: | Emmanuel Stip, MD, M.Sc. | Centre de recherche Fernand-Seguin, Université de Montréal |
More Information
No publications provided by Université de Montréal
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Université de Montréal |
| ClinicalTrials.gov Identifier: | NCT00290121 History of Changes |
| Other Study ID Numbers: | 2005-0503 |
| Study First Received: | February 8, 2006 |
| Last Updated: | March 13, 2013 |
| Health Authority: | Canada: Santé Canada |
Keywords provided by Université de Montréal:
|
Schizophrenia Atypical antipsychotics Weight gain Appetite fMRI |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Antipsychotic Agents Olanzapine Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 19, 2013