Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00492349
Status:
COMPLETED
Last Update Posted:
2022-01-05
First Post:
2007-06-26
Brief Title:
Varenicline Adjunctive Treatment in Schizophrenia
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Varenicline Adjunctive Treatment in Schizophrenia
Status:
COMPLETED
Status Verified Date:
2017-12
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:
The principal aim of the project is to conduct an off-label adjunctive clinical trial evaluating varenicline as a treatment for core neurobiological and clinical deficits in schizophrenia in addition to evaluating for smoking cessation in schizophrenia patients
Detailed Description:
This is a double-blind placebo controlled clinical trial in schizophrenia patients Outcome measures include biomarkers and clinical symptoms and functions and smoking cessation Neurobiological and cognitive markers will be measured for short term 2 weeks and longer-term 8 weeks Current schizophrenia treatments are mostly ineffective against primary negative symptoms and the cognitive and information processing deficits associated with the disorder Previous research has identified several neurophysiological deficits in schizophrenia that are enduring frequently occurring before psychosis and mark the disease liability These schizophrenia endophenotypes provide important targets for novel treatment development as they represent the core deficits of the disorder We hypothesize that sustained nicotinic and dopaminergic modulation by varenicline may ameliorate the core neurobiological deficits seen in schizophrenia patients which would lead to subsequent clinical improvement Neurobiological and neurocognitive markers and clinical and functional measures will be obtained to determine 1 short-term effect of varenicline on biomarkers and 2 longer-term improvement in clinical symptoms smoking cessation and functions and how biomarker changes predict these improvements
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