Ignite Creation Date:
2024-05-06 @ 2:19 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02011750
Status:
COMPLETED
Last Update Posted:
2018-02-14
First Post:
2013-06-21
Brief Title:
Pilot Trial of Valproate as Adjunctive Treatment for Toxoplasma Gondii Infection in Early Course Schizophrenia
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Pilot Trial of Valproate as Adjunctive Treatment for Toxoplasma Gondii
Status:
COMPLETED
Status Verified Date:
2018-02
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:
This is an exploratory study in Egypt that will combine a treatment trial among early course schizophrenia ECSZ patients with key analyses suggested by rodent studies Specifically the study will test the provocative results from animal studies indicating an impact of Toxoplasma Gondii TOX exposure on novelty seeking The study will also test whether exposure to TOX is associated with other cognitive and behavioral changes as well as changes in overall social function We will also explore the relative efficacy of Sodium Valproate Depakote DEP in improving clinical and overall social function among TOX exposed and unexposed patients
Hypotheses
1 At baseline TOX exposure is associated with increased novelty seeking clinical severity and impaired cognitive and overall social function in patients with SZ
2 Adjunctive DEP treatment improves clinical symptoms cognitive and social function in SZ particularly among TOX exposed SZ patients
3 Exploratory hypothesis adjunctive DEP reduces serological indices of TOX infection VIP and TH levels
Hypotheses
1 At baseline TOX exposure is associated with increased novelty seeking clinical severity and impaired cognitive and overall social function in patients with SZ
2 Adjunctive DEP treatment improves clinical symptoms cognitive and social function in SZ particularly among TOX exposed SZ patients
3 Exploratory hypothesis adjunctive DEP reduces serological indices of TOX infection VIP and TH levels
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