Phase 4
N=17
Effects of Intranasal Oxytocin on Satiety Signaling in People With Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01614093 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Food Consumption After Intervention — 7.9; 7.4 Grams
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oxytocin (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Food Consumption After Intervention |
7.9; 7.4 | — |
Summary
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT01614093). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.