Investigation of the Drug Dimethoxbenzylidene Anabaseine in Treating Schizophrenia Patients
Recruitment status was Recruiting
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Purpose
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 |
|---|---|---|
|
Schizophrenia Psychotic Disorders |
Drug: Dimethoxybenzylidene anabaseine (DMXB-A) Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase 1 Trial of 3-2,4 Dimethoxbenzylidene Anabaseine in Schizophrenia |
- Clinical ratings [ Time Frame: Measured at Month 1 ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Experimental: 1
Participants will take active experimental medication.
|
Drug: Dimethoxybenzylidene anabaseine (DMXB-A)
DMXB-A 150 mg sustained release bid
|
|
Placebo Comparator: 2
Participants will take placebo.
|
Drug: Dimethoxybenzylidene anabaseine (DMXB-A)
DMXB-A 150 mg sustained release bid
Drug: Placebo
Placebo dosed to match active medication
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| 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, Denver |
More Information
Publications:
| Responsible Party: | Robert Freedman, University of Colorado |
| ClinicalTrials.gov Identifier: | NCT00255918 History of Changes |
| Other Study ID Numbers: | R01 MH061412, DNBBS MC-R |
| Study First Received: | November 16, 2005 |
| Last Updated: | March 9, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Institute of Mental Health (NIMH):
|
Evoked Potentials 3-(2,4-dimethoxybenzylidene)anabaseine DMXB-A Receptors, Nicotinic |
Additional relevant MeSH terms:
|
Psychotic Disorders Mental Disorders Schizophrenia Schizophrenia and Disorders with Psychotic Features 3-(2,4-dimethoxybenzylidene)anabaseine Nicotinic Agonists |
Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013