Investigation of the Drug Dimethoxbenzylidene Anabaseine in Treating Schizophrenia Patients
Condition: Schizophrenia; Psychotic Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine the effectiveness of a drug, dimethoxbenzylidene anabaseine, in
      producing beneficial effects similar to that of nicotine in individuals with schizophrenia.
    

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.
    

Intervention name(s): Dimethoxybenzylidene anabaseine (DMXB-A); Placebo; Dimethoxybenzylidene anabaseine (DMXB-A)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): DMXB-A 150 mg immediate release followed by DMXB-A 75 mg 2 hours after the intiial dose; Placebo dosed to match active medication; DMXB-A 75 mg immediate release followed by DMXB-A 37.5 mg 2 hours after the intiial dose
Intervention MeSH terms: 3-(2,4-dimethoxybenzylidene)anabaseine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Evoked Potentials; 3-(2,4-dimethoxybenzylidene)anabaseine; DMXB-A; Receptors, Nicotinic