Effects of Intranasal Oxytocin on Satiety Signaling in People With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Oxytocin; Placebo
Intervention description: Single dose intranasal oxytocin (24 IU); Placebo- Sugar pill
Intervention MeSH terms: Oxytocin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 54 Years
Healthy volunteers: No
Keywords: Schizophrenia; Appetite; Oxytocin

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).