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Phase 4 N=17 Randomized Quadruple-blind Treatment

Effects of Intranasal Oxytocin on Satiety Signaling in People With Schizophrenia

Schizophrenia

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

OutcomeResultp-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).
View full record on ClinicalTrials.gov →

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.

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