Effects of Intranasal Oxytocin on Satiety Signaling in People With Schizophrenia

Study Overview
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Brief Summary
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The objective of this study is to test a single dose of intranasal oxytocin, compared to placebo, in a within subjects, crossover design, to see if oxytocin will improve satiety signaling (behaviorally and/or by self report) compared to placebo. If this single dose pilot paradigm shows an increase in satiety, it may be tested in follow-up studies as a prevention or treatment for weight gain and overeating in people with schizophrenia.

Official Title
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Effects of Intranasal Oxytocin on Satiety Signaling in People With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Oxytocin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DSM-IV diagnosis of schizophrenia or schizoaffective disorder Male or Female Age: 18 to 54 years Caucasian or Non-Caucasian Body Mass Index of ≥ 27 kg/m2 One month of stable antipsychotic treatment (same medication regimen and same dose) Exclusion Criteria: History of organic brain disease DSM-IV diagnosis of Mental Retardation DSM-IV diagnosis of Alcohol or Substance Dependence within the last six months (except nicotine) DSM-IV diagnosis of Alcohol or Substance Abuse within the last one month (except nicotine) Are pregnant or lactating Meet DSM-IV criteria for a past and/or current eating disorder via the SCID, or if they have a past medical history of an eating disorder, received treatment/counseling for an eating disorder and/or required hospitalization for an eating disorder. (If an otherwise undiagnosed eating disorder is detected during screening, referral to treatment will be provided.) Are taking weight-loss medications, whether over-the-counter (i.e. Hydroxycut, Stacker products, Metabo-Plus, CortiSlim), or prescribed, including appetite suppressants (Didrex, Tenuate, Sanorex, Mazanor, Adipex-P, Meridia, and Phentermine) and fat-absorption inhibitors (Xenical). Have cognitive impairment severe enough to preclude informed consent or valid responses on questionnaires. This is defined an as a score of less than 10 on the Evaluation to Sign Consent (ESC). Have a medical illness, dietary restrictions, or food allergies that, in the view of the investigators, would compromise participation. Are taking prostaglandins such as dinoprostone or misoprostol (because they interact with oxytocin).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 54 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: All participants will receive both active drug and placebo, differences between treatment conditions will be analyzed due to small sample order effects will not be analyzed
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxytocin/Placebo<br>Each participant will receive intranasal oxytocin 24IU or intranasal saline 24IU in random order. All results will be reported by treatment, the sample is too small for order effects. | Drug: Oxytocin<br>* Single dose intranasal oxytocin (24 IU)<br>Drug: Placebo<br>* Placebo- Sugar pill<br>|
| Active Comparator: Placebo/Oxytocin<br>Each participant will receive intranasal oxytocin 24IU or intranasal saline 24IU in random order. All results will be reported by treatment, the sample is too small for order effects. | Drug: Oxytocin<br>* Single dose intranasal oxytocin (24 IU)<br>Drug: Placebo<br>* Placebo- Sugar pill<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food Consumption After Intervention | We hypothesize that participants will have greater satiety signaling, indicated by less consumption of the Test Meal consumed 90 minutes after the preload. | 90 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Appetite, Oxytocin