Clinical trial NCT00290121: Appetite Increase in Schizophrenia Patients Treated With Atypical Antipsychotics
Official title: Cerebral Mechanism Involved in Appetite Increase in Schizophrenia Patients Treated With Atypical Antipsychotics (IIT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Atypical antipsychotics
Weight gain
Appetite
fMRI
Lead sponsor: Université de Montréal
Sponsor class: OTHER
Collaborators: name: Centre de Recherche de l'Institut Universitaire en santé Mentale de Montréal
name: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
name: Hopital du Sacre-Coeur de Montreal
name: Eli Lilly and Company
First posted: 2006-02-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: fMRI (functional magnetic resonance imaging with appetizing films)
timeFrame: 16 weeks after beginning of Olanzapine treatment
measure: Weight
timeFrame: 16 weeks after beginning of Olanzapine treatment
Secondary outcomes:
measure: Fasting glucose
timeFrame: 16 weeks after beginning of Olanzapine treatment
measure: Insulin
timeFrame: 16 weeks after beginning of Olanzapine treatment
measure: Leptin
timeFrame: 16 weeks after beginning of Olanzapine treatment
measure: Ghrelin
timeFrame: 16 weeks after beginning of Olanzapine treatment
measure: Endogenous cannabinoids
timeFrame: 16 weeks after beginning of Olanzapine treatment
measure: Lipid profile
timeFrame: 16 weeks after beginning of Olanzapine treatment
measure: PANSS (Positive and negative syndrome scale)
timeFrame: 16 weeks after beginning of Olanzapine treatment
measure: CDSS (Calgary Depression scale for schizophrenia)
timeFrame: 16 weeks after beginning of Olanzapine treatment
measure: Three factors eating questionnaire
timeFrame: 16 weeks after beginning of Olanzapine treatment
measure: Fagerstrom test for nicotine dependence
timeFrame: 16 weeks after beginning of Olanzapine treatment
measure: Adult ADHD (attention deficit hyperactivity disorder) self report scale
timeFrame: 16 weeks after beginning of Olanzapine treatment
measure: Age
timeFrame: 16 weeks after beginning of Olanzapine treatment
measure: Sexe
timeFrame: 16 weeks after beginning of Olanzapine treatment
measure: Weight
timeFrame: 16 weeks after beginning of Olanzapine treatment
measure: Abdominal circumference
timeFrame: 16 weeks after beginning of Olanzapine treatment
measure: Number and times of hospitalization
timeFrame: 16 weeks after beginning of Olanzapine treatment
measure: Blood pressure
timeFrame: 16 weeks after beginning of Olanzapine treatment
measure: Prolactin
timeFrame: 16 weeks after beginning of Olanzapine treatment
measure: Onset of disease
timeFrame: 16 weeks after beginning of Olanzapine treatment
measure: Level of education
timeFrame: 16 weeks after beginning of Olanzapine treatment
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre de recherche Fernand-Seguin
state: Quebec
Study officials:
affiliation: Centre de recherche Fernand-Seguin, Université de Montréal
name: Emmanuel Stip, MD, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.