Effects of Intranasal Oxytocin on Satiety Signaling in People With Schizophrenia

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

Single dose intranasal oxytocin (24 IU)

Placebo

Intervention Type DRUG

Placebo- Sugar pill

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.

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

Single dose intranasal oxytocin (24 IU)

Placebo

Intervention Type DRUG

Placebo- Sugar pill

Interventions

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Oxytocin

Single dose intranasal oxytocin (24 IU)

Intervention Type DRUG

Placebo

Placebo- Sugar pill

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

54 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No