Ignite Creation Date:
2024-05-05 @ 9:04 PM
Last Modification Date:
2024-10-26 @ 9:58 AM
Study NCT ID:
NCT00802919
Status:
COMPLETED
Last Update Posted:
2017-12-02
First Post:
2008-12-04
Brief Title:
Varenicline for Cognitive Deficits and Cigarette Smoking in Schizophrenia - Efficacy and Predictors
Sponsor:
Nathan Kline Institute for Psychiatric Research
Organization:
Nathan Kline Institute for Psychiatric Research
Study Overview
Official Title:
Varenicline for Cognitive Deficits and Cigarette Smoking in Schizophrenia - Efficacy and Predictors Independent Investigator Study
Status:
COMPLETED
Status Verified Date:
2017-10
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 a 8-week double-blind placebo controlled parallel group study of the efficacy of varenicline Chantix for smoking cessation in schizophrenic patients and its effect on cognitive function in patients with schizophreniaAt some sits evaluation of smoking measures is extended to 12 weeks Correlations will be made with biological predictors of efficacy a measures of nicotinic receptors in lymphocytes b DNMT1 and GAD67 mRNA in lymphocytes Subjects will be current cigarette smokers or history of regular smokers
Detailed Description:
This was a double-blind placebo controlled study of varenicline and matched placebo in patients with a diagnosis of schizophrenia or schizoaffective psychosis who were treated with antipsychotic medication and were cigarette smokers Three sites 2 US 1 Israel were supported by the Stanley grant A similar independently supported study was conducted in Beijing China We were allowed to access these data and combine them for our analysis of results Subjects at each site participated in a protocol which was approved by their institutional IRB All subjects signed informed consent
The study evaluated multiple measures of cigarette smoking cognitive functions by MATRICS battery Measurement and Treatment Research to Improve Cognition in Schizophrenia and psychiatric symptoms by PANSS Positive and Negative Symptom Scale SANS Schedule For Assessment Of Negative Symptoms and Calgary Depression scales Lymphocytes were collected for measurement of epigenetically related mRNAs
The study evaluated multiple measures of cigarette smoking cognitive functions by MATRICS battery Measurement and Treatment Research to Improve Cognition in Schizophrenia and psychiatric symptoms by PANSS Positive and Negative Symptom Scale SANS Schedule For Assessment Of Negative Symptoms and Calgary Depression scales Lymphocytes were collected for measurement of epigenetically related mRNAs
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 |
|---|---|---|---|
| FDA IND 102411 | None | None | None |