Ignite Creation Date:
2024-05-05 @ 10:01 PM
Last Modification Date:
2024-10-26 @ 10:12 AM
Study NCT ID:
NCT01012167
Status:
COMPLETED
Last Update Posted:
2022-01-12
First Post:
2009-04-28
Brief Title:
Oxytocin or Galantamine Versus Placebo for the Treatment of Negative Symptoms and Cognitive Impairments in Schizophrenia
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Oxytocin or Galantamine vs Placebo for the Treatment of Negative Symptoms and Cognitive Impairments in Schizophrenia
Status:
COMPLETED
Status Verified Date:
2022-01
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:
CIDAR-3
Brief Summary:
The project is designed to address the following two primary aims
1 To determine whether adjunctive oxytocin is superior to placebo for the treatment of persistent negative symptoms as measured by the SANS total score in people with schizophrenia
2 To determine whether adjunctive Galantamine is superior to placebo for the treatment of cognitive impairments as measured by improvement on a composite neurocognitive score in people with schizophrenia
The investigators will also address the following secondary aims
1 To determine whether people with schizophrenia treated with adjunctive oxytocin compared to placebo will show greater improvement on markers of negative symptom liability including social affiliation facial affect recognition olfactory discrimination initiation of smooth pursuit and latency of internally-driven saccades
2 To determine whether people with schizophrenia treated with adjunctive Galantamine compared to placebo will show greater improvement on markers of cognitive impairment liability including predictive pursuit P50 sensory gating and visual-spatial working memory
The investigators will address the following exploratory aims
1 To determine whether changes in markers of negative symptom liability are correlated with changes in SANS total score
2 To determine whether changes in markers of cognitive impairment liability are correlated with changes in the composite neurocognitive score
3 To determine the response to oxytocin of all cognition domains assessed by the MATRICS battery and to determine the response to Galantamine of all cognition domains assessed by the MATRICS which are not included in the primary neurocognitive outcome score
4 To determine whether there is a differential response of oxytocin and Galantamine on the SANS total score composite neurocognitive score and with the phenotypic measures of negative symptom and cognitive impairment liability
5 To determine whether oxytocin and Galantamine are associated with
adverse effects on positive or depressive symptoms
adverse effects on motor symptoms
adverse effects on laboratory and EKG measures
increased occurrence of side effects
social interest that is independent of sexual desire
1 To determine whether adjunctive oxytocin is superior to placebo for the treatment of persistent negative symptoms as measured by the SANS total score in people with schizophrenia
2 To determine whether adjunctive Galantamine is superior to placebo for the treatment of cognitive impairments as measured by improvement on a composite neurocognitive score in people with schizophrenia
The investigators will also address the following secondary aims
1 To determine whether people with schizophrenia treated with adjunctive oxytocin compared to placebo will show greater improvement on markers of negative symptom liability including social affiliation facial affect recognition olfactory discrimination initiation of smooth pursuit and latency of internally-driven saccades
2 To determine whether people with schizophrenia treated with adjunctive Galantamine compared to placebo will show greater improvement on markers of cognitive impairment liability including predictive pursuit P50 sensory gating and visual-spatial working memory
The investigators will address the following exploratory aims
1 To determine whether changes in markers of negative symptom liability are correlated with changes in SANS total score
2 To determine whether changes in markers of cognitive impairment liability are correlated with changes in the composite neurocognitive score
3 To determine the response to oxytocin of all cognition domains assessed by the MATRICS battery and to determine the response to Galantamine of all cognition domains assessed by the MATRICS which are not included in the primary neurocognitive outcome score
4 To determine whether there is a differential response of oxytocin and Galantamine on the SANS total score composite neurocognitive score and with the phenotypic measures of negative symptom and cognitive impairment liability
5 To determine whether oxytocin and Galantamine are associated with
adverse effects on positive or depressive symptoms
adverse effects on motor symptoms
adverse effects on laboratory and EKG measures
increased occurrence of side effects
social interest that is independent of sexual desire
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 |
|---|---|---|---|
| 1P50MH082999-01 | NIH | None | httpsreporternihgovquickSearch1P50MH082999-01 |