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Investigation of the Drug Dimethoxbenzylidene Anabaseine in Treating Schizophrenia Patients

This study is currently recruiting participants.
Study NCT00255918.   Last updated on September 19, 2008.   Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Investigation of the Drug Dimethoxbenzylidene Anabaseine in Treating Schizophrenia Patients
Official Title  Phase 1 Trial of 3-2,4 Dimethoxbenzylidene Anabaseine in Schizophrenia
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 brain's 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 Phase Phase I
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  Clinical ratings [ Time Frame: Measured at Month 1 ] [ Designated as safety issue: No ]
Secondary Outcome Measure 
Condition  Schizophrenia
Psychotic Disorders
Intervention  Drug: Dimethoxybenzylidene anabaseine (DMXB-A)
Drug: Placebo
MEDLINE PMIDs 15205879
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  100
Start Date  March 2004
Completion Date September 2009
Eligibility Criteria 

Inclusion Criteria:

  • Diagnosis of schizophrenia

Exclusion Criteria:

  • History of cardiovascular illness or neurological illness other than schizophrenia
  • Current substance abuse, including nicotine
  • History of clozapine use
Gender Both
Ages 18 Years to 60 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Robert Freedman, MD     303-315-8403     Robert.Freedman@UCHSC.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00255918
Organization ID R01 MH61412
Secondary IDs †† DNBBS MC-R
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Robert Freedman, MD     University of Colorado at Denver and Health Sciences Center    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date September 2008
First Received Date  November 16, 2005
Last Updated Date September 19, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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