Ignite Creation Date:
2024-05-05 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 9:48 AM
Study NCT ID:
NCT00663039
Status:
COMPLETED
Last Update Posted:
2019-09-09
First Post:
2008-04-17
Brief Title:
Effects of Oxytocin Nasal Spray on Social Affiliation
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Effects of Oxytocin Nasal Spray on Social Affiliation
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Schizophrenia is a complex and heritable disorder that encompasses several clinical symptom domains and functional impairments Existing treatments of schizophrenia although effective against positive symptoms fail to benefit negative symptoms the focus of the current protocol One of the strategies of novel drug development depends on identifying heritable physiological deficits that mark the disease liability and are thought to occur along the causal pathway of negative symptoms These heritable physiological deficits are often found in the biological relatives of schizophrenia proband particularly those who have schizophrenia related personality styles defined by schizophrenia spectrum personalities SSP in the diagnostic system even though they do not have the full-blown illness The current protocol will pilot a strategy of targeting biomarkers of negative symptoms using intranasal oxytocin in relatives of schizophrenia patients The drug probe studies in such non-clinical sample have several advantages including the absence of other drug treatment that may modulate the response and the lack of generalized deficits causing problems with task comprehensionengagement that may mute the therapeutic signal In addition finding of efficacy of the experimental drug on the target physiological deficit and the associated symptoms has clinical implications on its own rights This is because about 25 of subjects with schizophrenia spectrum personality disorders experience serious functional impairments
Oxytocin is an extensively used drug which is well tolerated with few serious side effects Several lines of evidence suggest its putative role in the treatment of negatives symptoms particularly a lack of social drive and related symptoms
Oxytocin is an extensively used drug which is well tolerated with few serious side effects Several lines of evidence suggest its putative role in the treatment of negatives symptoms particularly a lack of social drive and related symptoms
Detailed Description:
The current study will examine the effects of intranasal oxytocin on physiologicalcognitive markers of negative symptoms in 24 participants with schizophrenia spectrum traits Subjects will be tested in two one-day studies carried out at least a month apart Subjects will receive a 24 IU dose of intranasal oxytocin or placebo followed by a battery of cognitiveneurophysiological tests administered 50 minutes later completed over the next 155 minutes A second dose of the drug oxytocin or placebo will be administered 2 hours after the 1st in order to maintain therapeutic plasma levels and to complete all testing
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P50MH082999 | NIH | None | httpsreporternihgovquickSearchP50MH082999 |