Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00255918
Status:
COMPLETED
Last Update Posted:
2015-07-01
First Post:
2005-11-16
Brief Title:
Investigation of the Drug Dimethoxbenzylidene Anabaseine in Treating Schizophrenia Patients
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Phase 1 Trial of 3-24 Dimethoxbenzylidene Anabaseine in Schizophrenia
Status:
COMPLETED
Status Verified Date:
2015-06
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 study will determine the effectiveness of a drug dimethoxbenzylidene anabaseine in producing beneficial effects similar to that of nicotine in individuals with schizophrenia
Detailed Description:
Schizophrenia is a chronic and severe brain disorder that can significantly impact quality of life It is characterized by delusions paranoia and disordered thinking The cause of schizophrenia has not yet been determined However there are many treatments including drug therapy and cognitive behavioral therapy that may help to alleviate symptoms of the condition Nicotinic receptors are involved in a number of biological processes they are numerous throughout the central and peripheral nervous systems and are diverse in structure and expression Genetic and neurobiological research has identified decreased expression of the a7 nicotinic receptor as an element in schizophrenia that is related to poor psychosocial outcome Data indicate that drug therapy may reduce this deficit in receptor expression Nicotine has been found to stimulate the a7 nicotinic receptor however the physiological dependence associated with nicotine makes it an undesirable option Dimethoxbenzylidene anabaseine DMXB-A can stimulate the a7 nicotinic receptor its advantages include easy oral administration and the lack of dependence-causing effects This study will determine whether DMXB-A can safely and effectively stimulate the a7 nicotinic receptor in schizophrenia patients and reduce their neurobiological symptoms
This study will last 6 weeks Participants will have study visits each week for the duration of the study During each visit participants will be randomly assigned to receive either DMXB-A or placebo An electrocardiogram EKG will measure the heart function of participants and participants blood pressure will be measured After the first dose of either DMXB-A or placebo participants will receive a second dose 2 hours later An evoked potential test which measures the brains response to stimuli will be performed after both doses Neuropsychological tests such as verbal reasoning and visual retention will be performed following the second dose of either DMXB-A or placebo
This study will last 6 weeks Participants will have study visits each week for the duration of the study During each visit participants will be randomly assigned to receive either DMXB-A or placebo An electrocardiogram EKG will measure the heart function of participants and participants blood pressure will be measured After the first dose of either DMXB-A or placebo participants will receive a second dose 2 hours later An evoked potential test which measures the brains response to stimuli will be performed after both doses Neuropsychological tests such as verbal reasoning and visual retention will be performed following the second dose of either DMXB-A or placebo
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 |
|---|---|---|---|
| DNBBS MC-R | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH061412 |
| R01MH061412 | NIH | None | None |