Back to results

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

Primary Purpose

Schizophrenia

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Oxytocin

About this trial

This is an interventional basic science trial for Schizophrenia focused on measuring Schizophrenia, PET, Oxytocin

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Maryland Psychiatric Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oxytocin

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01123317

First Posted

May 12, 2010

Last Updated

August 15, 2019

Sponsor

University of Maryland, Baltimore

1. Study Identification

Unique Protocol Identification Number

NCT01123317

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Withdrawn

Why Stopped

Never started

Study Start Date

July 2010 (undefined)

Primary Completion Date

January 2011 (Anticipated)

Study Completion Date

January 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Maryland, Baltimore

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

Keywords

Schizophrenia, PET, Oxytocin

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Single

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oxytocin

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Oxytocin

Other Intervention Name(s)

Syntocinon

Intervention Description

Primary Outcome Measure Information:

Title

Oxytocin induced rCBF changes

Description

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

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Henry Holcomb, M.D.

Organizational Affiliation

MPRC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Maryland Psychiatric Research Center

City

Catonsville

State/Province

Maryland

ZIP/Postal Code

21228

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs