Ignite Creation Date:
2024-05-05 @ 9:25 PM
Last Modification Date:
2024-10-26 @ 10:04 AM
Study NCT ID:
NCT00884897
Status:
COMPLETED
Last Update Posted:
2019-10-02
First Post:
2009-04-20
Brief Title:
Oxytocin and Social Cognition in Schizophrenia
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Oxytocin and Social Cognition in Schizophrenia
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:
Objective Social Cognition and Emotional Intelligence have been shown to be deficient in patients with schizophrenia and these are not remediated by antipsychotic medications or psychosocial interventions Social cognition is associated with functional outcome an important step in striving for recovery in this population The hormone and neurotransmitter oxytocin which has been associated with social bonding and trust has been shown to improve measures of some aspects of social cognition in humans The study will assess the effect of acute administration of intranasal oxytocin on measures of social cognition and functioning as well as on emotional intelligence and symptoms
Study population The study population will include patients with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder who have been on a stable medication regimen for 6 weeks We will enroll a total of 30 subjects N15 placebo and N15 oxytocin groups
Experimental design and methods After a one week lead in phase participants will undergo 3 weeks of oxytocin 20 IU BID or placebo administration double blind in addition to their existing medication regimen Outcome measures will be administered during the lead in phase and at the end of the study drug administration phase under the acute effect of OT The primary outcome measure will be the Mayer-Salovey-Caruso Emotional Intelligence Test MSCEIT and the Maryland Assessment of Social Competence MASC Secondary measures include rating from the domains of social cognition emotion perception attributional style theory of mind and social perception symptom rating and measures of social anxiety and quality of life Side effects and symptoms will be measured weekly
Study population The study population will include patients with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder who have been on a stable medication regimen for 6 weeks We will enroll a total of 30 subjects N15 placebo and N15 oxytocin groups
Experimental design and methods After a one week lead in phase participants will undergo 3 weeks of oxytocin 20 IU BID or placebo administration double blind in addition to their existing medication regimen Outcome measures will be administered during the lead in phase and at the end of the study drug administration phase under the acute effect of OT The primary outcome measure will be the Mayer-Salovey-Caruso Emotional Intelligence Test MSCEIT and the Maryland Assessment of Social Competence MASC Secondary measures include rating from the domains of social cognition emotion perception attributional style theory of mind and social perception symptom rating and measures of social anxiety and quality of life Side effects and symptoms will be measured weekly
Detailed Description:
None
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 |