Investigation of the Drug Dimethoxbenzylidene Anabaseine in Treating Schizophrenia Patients - Full Text View

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 I

MedlinePlus related topics:

Psychotic Disorders Schizophrenia

U.S. FDA Resources

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

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

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
1: Experimental Participants will take active experimental medication.	Drug: Dimethoxybenzylidene anabaseine (DMXB-A) DMXB-A 150 mg sustained release bid
2: Placebo Comparator 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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255918

Contacts


Contact: Robert Freedman, MD	303-315-8403	Robert.Freedman@UCHSC.edu

Locations


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

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators


Principal Investigator:	Robert Freedman, MD	University of Colorado at Denver and Health Sciences Center

More Information

Publications:

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.

Responsible Party:	University of Colorado ( Robert Freedman )
Study ID Numbers:	R01 MH61412, DNBBS MC-R
First Received:	November 16, 2005
Last Updated:	September 19, 2008
ClinicalTrials.gov Identifier:	NCT00255918
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

Study placed in the following topic categories:

Schizophrenia

3-(2,4-dimethoxybenzylidene)anabaseine

Mental Disorders

Psychotic Disorders

Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Cholinergic Agonists

Nicotinic Agonists

Physiological Effects of Drugs

Cholinergic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 06, 2008

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00255918