We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Intranasal Oxytocin on Satiety Signaling in People With Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01614093
First Posted: June 7, 2012
Last Update Posted: October 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
MPRC, University of Maryland
March 20, 2012
June 7, 2012
April 14, 2017
September 21, 2017
October 23, 2017
June 2012
January 2014   (Final data collection date for primary outcome measure)
Food Consumption After Intervention [ Time Frame: 90 minutes ]
We hypothesize that participants will have greater satiety signaling, indicated by less consumption of the "Test Meal" consumed 90 minutes after the preload.
  • The effect of intranasal oxytocin on satiety signaling in people with schizophrenia. [ Time Frame: 4 weeks ]
    We hypothesize that participants will have greater satiety signaling, indicated by less consumption and/or higher levels of self-reported hunger ratings (visual analogue scale), during the oxytocin condition relative to placebo.
  • The effect of intranasal oxytocin on appetite hormone levels. [ Time Frame: 4 weeks ]
    We hypothesize that participants will show a slower and less dramatic drop of postprandial leptin, lower levels of postprandial insulin, and higher levels of cholesystokinin in the oxytocin condition relative to placebo.
Complete list of historical versions of study NCT01614093 on ClinicalTrials.gov Archive Site
Not Provided
  • The relationship of psychiatric symptoms (positive, negative, depressive) to satiety signaling. [ Time Frame: 4 weeks ]
  • The safety of single dose intranasal oxytocin relative to placebo. [ Time Frame: 4 weeks ]
  • The relationship between gustatory, smell functioning and stress in relation to satiety. [ Time Frame: 4 weeks ]
  • The relationship between oxytocin levels and satiety signaling. [ Time Frame: 4 weeks ]
Not Provided
Not Provided
 
Effects of Intranasal Oxytocin on Satiety Signaling in People With Schizophrenia
Effects of Intranasal Oxytocin on Satiety Signaling in People With Schizophrenia
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.
Not Provided
Interventional
Phase 4
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)
Primary Purpose: Treatment
Schizophrenia
  • Drug: Oxytocin
    Single dose intranasal oxytocin (24 IU)
  • Drug: Placebo
    Placebo- Sugar pill
  • Active Comparator: Oxytocin/Placebo
    Each participant will receive intranasal oxytocin 24IU or intranasal saline 24IU in random order. All results will be reported by treatment, the sample is too small for order effects.
    Interventions:
    • Drug: Oxytocin
    • Drug: Placebo
  • Active Comparator: Placebo/Oxytocin
    Each participant will receive intranasal oxytocin 24IU or intranasal saline 24IU in random order. All results will be reported by treatment, the sample is too small for order effects.
    Interventions:
    • Drug: Oxytocin
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
January 2014
January 2014   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years to 54 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01614093
HP-00049602
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
MPRC, University of Maryland
University of Maryland
Not Provided
Principal Investigator: Kimberly Warren, PhD Principal Investigator
University of Maryland
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP