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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00255918 |
This study will determine the effectiveness of a drug, dimethoxbenzylidene anabaseine, in producing beneficial effects similar to that of nicotine in individuals with schizophrenia.
Condition | Intervention | Phase |
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Schizophrenia Psychotic Disorders |
Drug: Dimethoxybenzylidene anabaseine (DMXB-A) Drug: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 1 Trial of 3-2,4 Dimethoxbenzylidene Anabaseine in Schizophrenia |
Estimated Enrollment: | 100 |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will take active experimental medication.
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Drug: Dimethoxybenzylidene anabaseine (DMXB-A)
DMXB-A 150 mg sustained release bid
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2: Placebo Comparator
Participants will take placebo.
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Drug: Dimethoxybenzylidene anabaseine (DMXB-A)
DMXB-A 150 mg sustained release bid
Drug: Placebo
Placebo dosed to match active medication
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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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Robert Freedman, MD | 303-315-8403 | Robert.Freedman@UCHSC.edu |
United States, Colorado | |
University of Colorado General Clinical Research Center | Recruiting |
Denver, Colorado, United States, 80262 | |
Contact: Robert Freedman, MD 303-315-8403 Robert.Freedman@UCHSC.edu | |
Principal Investigator: Robert Freedman, MD | |
Sub-Investigator: Ann Olincy, MD |
Principal Investigator: | Robert Freedman, MD | University of Colorado at Denver and Health Sciences Center |
Responsible Party: | University of Colorado ( Robert Freedman ) |
Study ID Numbers: | R01 MH61412, DNBBS MC-R |
Study First Received: | November 16, 2005 |
Last Updated: | September 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00255918 |
Health Authority: | United States: Food and Drug Administration |
Evoked Potentials 3-(2,4-dimethoxybenzylidene)anabaseine DMXB-A Receptors, Nicotinic |
Schizophrenia 3-(2,4-dimethoxybenzylidene)anabaseine Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Agonists Nicotinic Agonists |
Physiological Effects of Drugs Cholinergic Agents Pharmacologic Actions |