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Investigation of the Drug Dimethoxbenzylidene Anabaseine in Treating Schizophrenia Patients
This study is currently recruiting participants.
Study NCT00255918   Information provided by National Institute of Mental Health (NIMH)
First Received: November 16, 2005   Last Updated: March 9, 2009   History of Changes

November 16, 2005
March 9, 2009
March 2004
June 2009   (final data collection date for primary outcome measure)
Clinical ratings [ Time Frame: Measured at Month 1 ] [ Designated as safety issue: No ]
  • P50 evoked potential inhibition
  • neuropsychological performance
Complete list of historical versions of study NCT00255918 on ClinicalTrials.gov Archive Site
 
 
 
Investigation of the Drug Dimethoxbenzylidene Anabaseine in Treating Schizophrenia Patients
Phase 1 Trial of 3-2,4 Dimethoxbenzylidene Anabaseine in Schizophrenia

This study will determine the effectiveness of a drug, dimethoxbenzylidene anabaseine, in producing beneficial effects similar to that of nicotine in individuals with schizophrenia.

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.

Phase I
Interventional
Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
  • Schizophrenia
  • Psychotic Disorders
  • Drug: Dimethoxybenzylidene anabaseine (DMXB-A)
  • Drug: Placebo
  • Experimental: Participants will take active experimental medication.
  • Placebo Comparator: Participants will take placebo.
Martin LF, Kem WR, Freedman R. Alpha-7 nicotinic receptor agonists: potential new candidates for the treatment of schizophrenia. Psychopharmacology (Berl). 2004 Jun;174(1):54-64. Epub 2004 Feb 19. Review.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
100
September 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact: Robert Freedman, MD 303-315-8403 Robert.Freedman@UCHSC.edu
United States
 
NCT00255918
Robert Freedman, University of Colorado
R01 MH061412, DNBBS MC-R
National Institute of Mental Health (NIMH)
 
Principal Investigator: Robert Freedman, MD University of Colorado at Denver and Health Sciences Center
National Institute of Mental Health (NIMH)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP