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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

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Appetite, Oxytocin

Eligibility Criteria

18 Years - 54 Years (Adult)All SexesDoes not accept healthy volunteers

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

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.

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

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

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

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Effects of Intranasal Oxytocin on Satiety Signaling in People With Schizophrenia

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