Ignite Creation Date:
2024-05-05 @ 10:31 PM
Last Modification Date:
2024-10-26 @ 10:19 AM
Study NCT ID:
NCT01123317
Status:
WITHDRAWN
Last Update Posted:
2019-08-19
First Post:
2010-05-12
Brief Title:
Brain Blood Flow Changes Elicited by Oxytocin in Volunteers With and Without Schizophrenia
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Never started
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 oxytocins 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 15 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 systems physiological response to oxytocin is predictive of a subjects 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 amygdalas response during social and emotional decisions When administered intranasally OT may be beneficial for the treatment of negative symptoms in schizophrenia by enhancing a persons 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
Functional magnetic resonance imaging MRI studies show that oxytocin modulates the amygdalas response during social and emotional decisions When administered intranasally OT may be beneficial for the treatment of negative symptoms in schizophrenia by enhancing a persons 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None