Effects of Intranasal Oxytocin on Satiety Signaling in People With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MPRC, University of Maryland
ClinicalTrials.gov Identifier:
NCT01614093
First received: March 20, 2012
Last updated: April 14, 2014
Last verified: April 2014

March 20, 2012
April 14, 2014
June 2012
January 2014   (final data collection date for primary outcome measure)
  • The effect of intranasal oxytocin on satiety signaling in people with schizophrenia. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT01614093 on ClinicalTrials.gov Archive Site
  • The relationship of psychiatric symptoms (positive, negative, depressive) to satiety signaling. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • The safety of single dose intranasal oxytocin relative to placebo. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • The relationship between gustatory, smell functioning and stress in relation to satiety. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • The relationship between oxytocin levels and satiety signaling. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: Oxytocin
    Single dose intranasal oxytocin (24 IU)
  • Drug: Placebo
    Placebo control
  • Active Comparator: Oxytocin
    Intervention: Drug: Oxytocin
  • Placebo Comparator: Placebo
    Intervention: 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
  • Current diagnosis of Type I or II Diabetes defined as a fasting blood glucose level of > 99 mg/dL.
  • 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).
Both
18 Years to 54 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01614093
HP-00090751
Yes
MPRC, University of Maryland
University of Maryland
Not Provided
Principal Investigator: Kimberly Warren, PhD Principal Investigator
University of Maryland
April 2014

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