Effects of Intranasal Oxytocin on Satiety Signaling in People With Schizophrenia

Schizophrenia Clinical Trial

Official title:

Effects of Intranasal Oxytocin on Satiety Signaling in People With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01614093
• Other study ID #: HP-00049602
• Status: Completed
• Phase: Phase 4
• Start date: June 2012
• Est. completion date: January 2014

Study information

• Verified date: August 2019
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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).

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Oxytocin
Single dose intranasal oxytocin (24 IU)
• Placebo
Placebo- Sugar pill

Locations

Country	Name	City	State
United States	Maryland Psychiatric Research Center	Catonsville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

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