Brain Blood Flow Changes Elicited by Oxytocin in Volunteers With and Without Schizophrenia

NCT01123317 | Withdrawn DMC

• 1 other identifier: HP-00041288
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess how oxytocin delivered intranasally changes regional brain blood flow measured by positron emission tomography (PET) in conjunction with oxygen-15 labeled water in persons with schizophrenia. The objective is to better our understanding of oxytocin's role in the modulation of social judgment in schizophrenia and provide more information as to potential uses of oxytocin or a similar drug analog in treating certain features of schizophrenia and other neuropsychiatric disorders.

Conditions

Schizophrenia

Keywords

Schizophrenia; PET; Oxytocin

Outcome Measures

Primary Outcomes (1)

• Oxytocin induced rCBF changes

  Oxytocin induced rCBF changes in the amygdala, ventral striatum, hypothalamus and anterior hippocampus (post-drug versus pre-drug, resting and task conditions

  2 years

Study Arms (1)

Oxytocin

EXPERIMENTAL

Subjects will be randomly assigned to either OT-Placebo or Placebo-OT order for PET scan drug administration and will receive the first of the two intranasal doses at Pet scan 1 and the second intranasal dose of the subsequent treatment at Pet Scan 2

Drug: Oxytocin

Interventions

Oxytocin DRUG

Subjects will be randomly assigned to either OT-Placebo or Placebo-OT order for PET scan drug administration and will receive the first of the two intranasal doses at Pet scan 1 and the second intranasal dose of the subsequent treatment at Pet Scan 2

Also known as: Syntocinon

Oxytocin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Normal volunteers: Age range: 18-55 years of age
• Normal Volunteers: No psychiatric illness in self; no psychotic illness in first degree relatives
• Normal Volunteers: No previous history of substance dependence in last 6 months; no substance abuse in last month
• Normal Volunteers: No contraindication for MRI scanning (i.e. cardiac pacemaker, prosthesis)
• Normal Volunteers: Not pregnant
• Normal Volunteers: No major medical illness (e.g. seizure disorder) or medication that affects brain structure (e.g. steroids)
• Normal Volunteers: Participation in Healthy Subject Recruitment protocol (HP-00042350).
• Patient Volunteers: DSM-IV diagnosis of schizophrenia
• Patient Volunteers: Voluntary and competent to sign an informed consent
• Patient Volunteers: No contraindication for MRI scanning (i.e. cardiac pacemaker, prosthesis)
• Patient Volunteers: No previous history of substance dependence in last 6 months; no substance abuse in last month
• Patient Volunteers: Not pregnant
• Patient Volunteers: No major medical illness other than schizophrenia that affects brain structure (e.g. seizure disorder); not currently taking medication other than that for schizophrenia that affects brain structure (e.g. steroids)
• Patient Volunteers: No diagnosis of Major Depressive Disorder within last 6 months
• Patient Volunteers: SANS Asociality global score 2 or greater

You may not qualify if:

• Normal Volunteers: Age outside of specified range -Normal Volunteers: Psychiatric illness in self; psychotic illness in first- degree relative
• Normal Volunteers: Previous history of substance dependence in last 6 months; substance abuse in last month
• Normal Volunteers: Contraindication for MRI scanning (i.e. cardiac pacemaker, prosthesis)
• Normal Volunteers: Pregnant
• Normal Volunteers: Major medical illness (e.g. seizure disorder) or medication that affects brain structure (e.g. steroids)
• Patient Volunteers: Age outside of specified range
• Patient Volunteers: Contraindication for MRI scanning (i.e. cardiac pacemaker, prosthesis)
• Patient Volunteers: History of substance dependence in last 6 months; substance abuse in last month
• Patient Volunteers: Pregnancy
• Patient Volunteers: Major medical illness other than schizophrenia that affects brain structure; currently taking medication other than that for schizophrenia that affects brain structure
• Patient Volunteers: Diagnosis of Major Depressive Disorder within last 6 months
• Patient Volunteers: SANS Asociality global score \< 2
• Patient Volunteers: Change in antipsychotic medication (type and dose) within the last 4 weeks

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

Maryland Psychiatric Research Center

Catonsville, Maryland, 21228, United States

Location

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

Study Officials

• Henry Holcomb, M.D.

  MPRC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Maryland Psychiatric Research Center

Study Record Dates

• First Submitted: May 12, 2010
• First Posted: May 14, 2010
• Study Start: July 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2013
• Last Updated: August 19, 2019

Record last verified: 2019-08

Locations

US (1)