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Trial · Interventional

CompletedPhase 4Results postedRegistry data

Effects of Intranasal Oxytocin on Satiety Signaling in People With Schizophrenia

Overview

Status
Completed
Phase
Phase 4
Enrollment
24 participants (actual)
Sponsor
University of Maryland, Baltimore · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Jun 2012
Primary completion
Jan 2014
Completion
Jan 2014
First posted
7 Jun 2012 (estimated)
Last update posted
28 Aug 2019
Conditions
Schizophrenia

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201320142015
  1. Ph 4

    Effects of Intranasal Oxytocin on Satiety Signaling in People With Schizophrenia

    NCT01614093

    Jun 2012 to Jan 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • OxytocinDrug
  • PlaceboDrug

Arms2

  • Active comparator

    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.

  • Active comparator

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Food Consumption After Intervention

    Time frame · 90 minutes

    Registry description

    We hypothesize that participants will have greater satiety signaling, indicated by less consumption of the "Test Meal" consumed 90 minutes after the preload.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 90 minutes

Food Consumption After Intervention

GroupValue (Grams)Spread
Oxytocin/Placebo7.913.0

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
OxytocinEach 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.0 / 160 / 162 / 16
PlaceboEach 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.0 / 160 / 164 / 16

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 54 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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).

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