Clinical trial NCT01614093: Effects of Intranasal Oxytocin on Satiety Signaling in People With Schizophrenia
Official title: Effects of Intranasal Oxytocin on Satiety Signaling in People With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Appetite
Oxytocin
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2012-06-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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
Primary purpose: TREATMENT

Brief 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).

Primary outcomes:
measure: Food Consumption After Intervention
timeFrame: 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Catonsville
country: United States
facility: Maryland Psychiatric Research Center
state: Maryland
Study officials:
affiliation: Principal Investigator
name: Kimberly Warren, PhD
role: PRINCIPAL_INVESTIGATOR
References: