Investigation of the Drug Dimethoxbenzylidene Anabaseine in Treating Schizophrenia Patients

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00255918
First received: November 16, 2005
Last updated: June 30, 2015
Last verified: June 2015

November 16, 2005
June 30, 2015
March 2004
October 2005   (final data collection date for primary outcome measure)
Total Scale Score for the Repeatable Battery for the Assessment of Neuropsychological Status [ Time Frame: Measured at 2 hours after drug or placebo ] [ Designated as safety issue: No ]
ten subtests which give five scores, one for each of the five domains tested (immediate memory, visuospatial/constructional, language, attention, delayed memory).
  • 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: Measured 4 hours after drug or placebo administration ] [ Designated as safety issue: No ]
    Brief Psychiatric Rating Scale (BPRS) is a rating scale used to measure psychiatric symptoms
  • P50 auditory evoked potential test amplitude/conditioning amplitude ratio [ Time Frame: Measured 2.5 hours after drug or placebo administration ] [ Designated as safety issue: No ]
    The evoked response amplitude measured in mV to the initial auditory stimulus which is compared to the evoked response amplitude which is measured in mV to a second auditory stimulus that occurs 500 ms later.
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Not Provided
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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: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Schizophrenia
  • Psychotic Disorders
  • Drug: Dimethoxybenzylidene anabaseine (DMXB-A)
    DMXB-A 150 mg immediate release followed by DMXB-A 75 mg 2 hours after the intiial dose
  • Drug: Placebo
    Placebo dosed to match active medication
  • Drug: Dimethoxybenzylidene anabaseine (DMXB-A)
    DMXB-A 75 mg immediate release followed by DMXB-A 37.5 mg 2 hours after the intiial dose
  • Experimental: Dimethoxybenzylidene anabaseine 75 mg
    Participants will take active experimental medication (Dimethoxybenzylidene anabaseine (DMXB-A) 75 mg)
    Interventions:
    • Drug: Dimethoxybenzylidene anabaseine (DMXB-A)
    • Drug: Placebo
    • Drug: Dimethoxybenzylidene anabaseine (DMXB-A)
  • Placebo Comparator: Placebo
    Participants will take placebo.
    Interventions:
    • Drug: Dimethoxybenzylidene anabaseine (DMXB-A)
    • Drug: Placebo
    • Drug: Dimethoxybenzylidene anabaseine (DMXB-A)
  • Experimental: Dimethoxybenzylidene anabaseine 150 mg
    Participants will take active experimental medication (Dimethoxybenzylidene anabaseine (DMXB-A) 150 mg)
    Interventions:
    • Drug: Dimethoxybenzylidene anabaseine (DMXB-A)
    • Drug: Placebo
    • Drug: Dimethoxybenzylidene anabaseine (DMXB-A)
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.
 
Completed
12
October 2005
October 2005   (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 information is only displayed when the study is recruiting subjects
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
June 2015

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