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Investigation of the Drug Dimethoxbenzylidene Anabaseine in Treating Schizophrenia Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University of Colorado, Denver
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00255918
First received: November 16, 2005
Last updated: November 13, 2013
Last verified: November 2013

November 16, 2005
November 13, 2013
March 2004
June 2016   (final data collection date for primary outcome measure)
MATRICS-CCB-Total Scale Score [ Time Frame: Measured at Month 1 ] [ Designated as safety issue: No ]
National Institute of Mental Health (NIMH) Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery Statistically Adjusted-score (MATRICS-CCB) is a neuro-cognitive test
  • neuropsychological performance
  • P50 evoked potential inhibition
Complete list of historical versions of study NCT00255918 on ClinicalTrials.gov Archive Site
  • Brief Psychiatric Rating Scale [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Brief Psychiatric Rating Scale (BPRS) is a rating scale used to measure psychiatric symptoms
  • Scale for the Assessment of Negative Symptoms [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Scale for the Assessment of Negative Symptoms (SANS) is a rating scale to measure negative symptoms
Not Provided
Hippocampal BOLD response [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Hippocampal BOLD response in resting state Functional magnetic resonance imaging (fMRI)
Not Provided
 
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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Schizophrenia
  • Psychotic Disorders
  • Drug: Dimethoxybenzylidene anabaseine (DMXB-A)
    DMXB-A 150 mg sustained release bid
  • Drug: Placebo
    Placebo dosed to match active medication
  • Experimental: Dimethoxybenzylidene anabaseine
    Participants will take active experimental medication (Dimethoxybenzylidene anabaseine (DMXB-A) )
    Intervention: Drug: Dimethoxybenzylidene anabaseine (DMXB-A)
  • Placebo Comparator: Placebo
    Participants will take placebo.
    Interventions:
    • Drug: Dimethoxybenzylidene anabaseine (DMXB-A)
    • Drug: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
September 2016
June 2016   (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
03-0857, R01MH061412, DNBBS MC-R
Yes
University of Colorado, Denver
University of Colorado, Denver
National Institute of Mental Health (NIMH)
Principal Investigator: Robert Freedman, MD University of Colorado, Denver
University of Colorado, Denver
November 2013

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