Schizophrenia Clinical Trial
Official title:
Effects of Intranasal Oxytocin on Satiety Signaling in People With Schizophrenia
NCT number | NCT01614093 |
Other study ID # | HP-00049602 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | June 2012 |
Est. completion date | January 2014 |
Verified date | August 2019 |
Source | University of Maryland, Baltimore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | January 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 54 Years |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
United States | Maryland Psychiatric Research Center | Catonsville | Maryland |
Lead Sponsor | Collaborator |
---|---|
University of Maryland, Baltimore |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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