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
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: Oxytocin
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Intranasal Oxytocin on Satiety Signaling in People With Schizophrenia

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: June 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oxytocin Drug: Oxytocin
Single dose intranasal oxytocin (24 IU)
Placebo Comparator: Placebo Drug: Placebo
Placebo control

  Eligibility

Ages Eligible for Study:   18 Years to 54 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01614093

Locations
United States, Maryland
Maryland Psychiatric Research Center
Catonsville, Maryland, United States, 21716
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Kimberly Warren, PhD Principal Investigator
  More Information

Additional Information:
No publications provided

Responsible Party: MPRC, Dr. Kimberly Warren, University of Maryland
ClinicalTrials.gov Identifier: NCT01614093     History of Changes
Other Study ID Numbers: HP-00090751
Study First Received: March 20, 2012
Last Updated: April 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Maryland:
Schizophrenia
Appetite
Oxytocin

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014