Investigation of the Drug Dimethoxbenzylidene Anabaseine in Treating Schizophrenia Patients

June 30, 2015 updated by: University of Colorado, Denver

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80262
        • University of Colorado General Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dimethoxybenzylidene anabaseine 75 mg
Participants will take active experimental medication (Dimethoxybenzylidene anabaseine (DMXB-A) 75 mg)
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
Placebo Comparator: Placebo
Participants will take placebo.
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 150 mg
Participants will take active experimental medication (Dimethoxybenzylidene anabaseine (DMXB-A) 150 mg)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Scale Score for the Repeatable Battery for the Assessment of Neuropsychological Status
Time Frame: Measured at 2 hours after drug or placebo
ten subtests which give five scores, one for each of the five domains tested (immediate memory, visuospatial/constructional, language, attention, delayed memory).
Measured at 2 hours after drug or placebo

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Psychiatric Rating Scale
Time Frame: Measured 4 hours after drug or placebo administration
Brief Psychiatric Rating Scale (BPRS) is a rating scale used to measure psychiatric symptoms
Measured 4 hours after drug or placebo administration
P50 auditory evoked potential test amplitude/conditioning amplitude ratio
Time Frame: Measured 2.5 hours after drug or placebo administration
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.
Measured 2.5 hours after drug or placebo administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Robert Freedman, MD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

November 16, 2005

First Submitted That Met QC Criteria

November 16, 2005

First Posted (Estimate)

November 21, 2005

Study Record Updates

Last Update Posted (Estimate)

July 1, 2015

Last Update Submitted That Met QC Criteria

June 30, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-0857
  • R01MH061412 (U.S. NIH Grant/Contract)
  • DNBBS MC-R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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