Investigation of the Drug Dimethoxbenzylidene Anabaseine in Treating Schizophrenia Patients

NCT ID: NCT00255918

Last Updated: 2015-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2005-10-31

Brief 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.

Conditions

Schizophrenia; Psychotic Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dimethoxybenzylidene anabaseine 75 mg

Participants will take active experimental medication (Dimethoxybenzylidene anabaseine (DMXB-A) 75 mg)

Group Type: EXPERIMENTAL

Dimethoxybenzylidene anabaseine (DMXB-A)

Intervention Type: DRUG

DMXB-A 150 mg immediate release followed by DMXB-A 75 mg 2 hours after the intiial dose

Placebo

Intervention Type: DRUG

Placebo dosed to match active medication

Dimethoxybenzylidene anabaseine (DMXB-A)

Intervention Type: DRUG

DMXB-A 75 mg immediate release followed by DMXB-A 37.5 mg 2 hours after the intiial dose

Placebo

Participants will take placebo.

Group Type: PLACEBO_COMPARATOR

Dimethoxybenzylidene anabaseine (DMXB-A)

Intervention Type: DRUG

DMXB-A 150 mg immediate release followed by DMXB-A 75 mg 2 hours after the intiial dose

Placebo

Intervention Type: DRUG

Placebo dosed to match active medication

Dimethoxybenzylidene anabaseine (DMXB-A)

Intervention Type: DRUG

DMXB-A 75 mg immediate release followed by DMXB-A 37.5 mg 2 hours after the intiial dose

Dimethoxybenzylidene anabaseine 150 mg

Participants will take active experimental medication (Dimethoxybenzylidene anabaseine (DMXB-A) 150 mg)

Group Type: EXPERIMENTAL

Dimethoxybenzylidene anabaseine (DMXB-A)

Intervention Type: DRUG

DMXB-A 150 mg immediate release followed by DMXB-A 75 mg 2 hours after the intiial dose

Placebo

Intervention Type: DRUG

Placebo dosed to match active medication

Dimethoxybenzylidene anabaseine (DMXB-A)

Intervention Type: DRUG

DMXB-A 75 mg immediate release followed by DMXB-A 37.5 mg 2 hours after the intiial dose

Interventions

Dimethoxybenzylidene anabaseine (DMXB-A)

DMXB-A 150 mg immediate release followed by DMXB-A 75 mg 2 hours after the intiial dose

Intervention Type: DRUG

Placebo

Placebo dosed to match active medication

Intervention Type: DRUG

Dimethoxybenzylidene anabaseine (DMXB-A)

DMXB-A 75 mg immediate release followed by DMXB-A 37.5 mg 2 hours after the intiial dose

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Freedman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado General Clinical Research Center

Denver, Colorado, United States

Countries

United States

References

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. doi: 10.1007/s00213-003-1750-1. Epub 2004 Feb 19.

Reference Type: BACKGROUND

PMID: 15205879 (View on PubMed)

Other Identifiers

R01MH061412

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DNBBS MC-R

Identifier Type: -

Identifier Source: secondary_id

03-0857

Identifier Type: -

Identifier Source: org_study_id