Effects of Intranasal Oxytocin on Satiety Signaling in People With Schizophrenia

NCT01614093 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: HP-00049602
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Appetite; Oxytocin

Outcome Measures

Primary Outcomes (1)

• 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.

  90 minutes

Study Arms (2)

Oxytocin/Placebo

ACTIVE COMPARATOR

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.

Drug: Oxytocin; Drug: Placebo

Placebo/Oxytocin

ACTIVE COMPARATOR

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.

Drug: Oxytocin; Drug: Placebo

Interventions

Oxytocin DRUG

Single dose intranasal oxytocin (24 IU)

Oxytocin/Placebo; Placebo/Oxytocin

Placebo DRUG

Placebo- Sugar pill

Oxytocin/Placebo; Placebo/Oxytocin

Eligibility Criteria

• Age: 18 Years - 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

Maryland Psychiatric Research Center

Catonsville, Maryland, 21716, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Schizophrenia

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Kimberly R. Warren, Ph.D.
• Organization: Morgan State University

kimberly.warren@gmail.com

443-885-3492

Study Officials

• Kimberly Warren, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Kimberly Warren

Model Details: 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

Study Record Dates

• First Submitted: March 20, 2012
• First Posted: June 7, 2012
• Study Start: June 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: August 28, 2019
• Results First Posted: September 21, 2017

Record last verified: 2019-08

Locations

US (1)