Effects of Intranasal Oxytocin on Satiety Signaling in People With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Oxytocin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Appetite, Oxytocin
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).
Sites / Locations
- Maryland Psychiatric Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Oxytocin/Placebo
Placebo/Oxytocin
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01614093
First Posted
March 20, 2012
Last Updated
August 15, 2019
Sponsor
University of Maryland, Baltimore
1. Study Identification
Unique Protocol Identification Number
NCT01614093
Brief Title
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
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Appetite, Oxytocin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxytocin/Placebo
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo/Oxytocin
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Description
Single dose intranasal oxytocin (24 IU)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo- Sugar pill
Primary Outcome Measure Information:
Title
Food Consumption After Intervention
Description
We hypothesize that participants will have greater satiety signaling, indicated by less consumption of the "Test Meal" consumed 90 minutes after the preload.
Time Frame
90 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly Warren, PhD
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maryland Psychiatric Research Center
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21716
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mprc.umaryland.edu
Description
Related Info
Learn more about this trial
Effects of Intranasal Oxytocin on Satiety Signaling in People With Schizophrenia
We'll reach out to this number within 24 hrs