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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by University of Maryland.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT01123317
First received: May 12, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Schizophrenia
Drug: Oxytocin

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Brain Blood Flow Changes Elicited by Oxytocin in Healthy and Schizophrenic Volunteers, an Assessment Using Positron Emission Tomography and 15-Oxygen Labeled Water

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Oxytocin induced rCBF changes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Oxytocin induced rCBF changes in the amygdala, ventral striatum, hypothalamus and anterior hippocampus (post-drug versus pre-drug, resting and task conditions


Estimated Enrollment: 30
Study Start Date: July 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxytocin
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
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
Other Name: Syntocinon

Detailed Description:

Schizophrenia is a severely debilitating psychiatric disorder that afflicts approximately 1% of the population (American Psychiatric Association, 1994) and is a serious public health problem. The specific mechanism of schizophrenia remains unknown. Affective responsivity and adaptive social behaviors are fundamental impairments in people with schizophrenia. These features have a detrimental impact on function in many areas of daily life. Unfortunately, the brain mechanisms that underlie these problems are still not understood. This study will use positron emission tomography (PET) and regional cerebral blood flow (rCBF) measures to ascertain the timing (1.5 hour period) of OT action on absolute regional brain activity in schizophrenia (SZ) and healthy control (HC) subjects. Particular focus will be on the amygdala, ventral striatum, anterior hippocampus and hypothalamus (neural regions involved in affliative behavior). Subjects will be studied with intranasally administered oxytocin and placebo while at rest and while making judgments about emotional faces. This approach will tell us to what extent the amygdala and limbic system's physiological response to oxytocin is predictive of a subject's behavioral sensitivity to this neuropeptide. The elucidation of this information may have a significant impact on predicting functional outcome and novel drug treatments in schizophrenia.

Functional magnetic resonance imaging (MRI) studies show that oxytocin modulates the amygdala's response during social and emotional decisions. When administered intranasally, OT may be beneficial for the treatment of negative symptoms in schizophrenia by enhancing a person's affiliative behavior and diminishing distrust. It is not, however, known to what extent intranasal oxytocin modifies regional neurotransmission and human brain metabolism. There are at present no studies in animals or humans specifically examining the time course action of OT on whole brain activity.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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
  • Patient Volunteers: No change in antipsychotic medication (type and dose) within the last 4 weeks
  • Patient volunteers: Age range: 18-55 years of age

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01123317

Contacts
Contact: Adriana M Halaby, B.S. 410-402-6017 ahalaby@mprc.umaryland.edu
Contact: Elena Spieker, B.S. ESpieker@mprc.umaryland.edu

Locations
United States, Maryland
Maryland Psychiatric Research Center Not yet recruiting
Catonsville, Maryland, United States, 21228
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Henry Holcomb, M.D. MPRC
  More Information

No publications provided

Responsible Party: Henry Holcomb, Maryland Psychiatric Research Center
ClinicalTrials.gov Identifier: NCT01123317     History of Changes
Other Study ID Numbers: HP-00041288
Study First Received: May 12, 2010
Last Updated: May 12, 2010
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of Maryland:
Schizophrenia
PET
Oxytocin

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014