Investigation of the Drug Dimethoxbenzylidene Anabaseine in Treating Schizophrenia Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Schizophrenia, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 7/11/2015 |
| Start Date: | March 2004 |
| End Date: | September 2016 |
| Contact: | Robert Freedman, MD |
| Email: | Robert.Freedman@UCHSC.edu |
| Phone: | 303-315-8403 |
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.
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.
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.
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
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