Nicotinic Receptors and Schizophrenia

• Status: Withdrawn
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study proposes to conduct a clinical trial comparison of olanzapine and the combination of a nicotinic cholinergic agonist, 3-[2,4-Dimethoxybenzylidene]anabaseine (DMXB-A) with a dopamine D2 receptor antagonist, the mechanism common to all antipsychotic drugs, to test the hypothesis that 7-nicotinic receptor agonism may be an additional necessary factor that enhances the efficacy of olanzapine that allows its slight superiority to risperidone. This trial would enroll patients taking olanzapine and record baseline measurements of clinical symptoms, cognition, metabolic parameters, and extrapyramidal side effects. The subjects would then be randomized to receive either risperidone or risperidone plus DMXB-A for 6 weeks and then would again have measurements of clinical symptoms, cognition, metabolic parameters and extrapyramidal side effects.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development
• Collaborator: University of Colorado, Denver
• Treatments: 3-(2,4-dimethoxybenzylidene)anabaseine; Olanzapine; Risperidone

Criteria

Inclusion Criteria:

• BMI > 25

• Diagnosis of schizophrenia or schizoaffective disorder

• 18-75 years of age

• Taking olanzapine at least 10 mg

• If female, willing to use acceptable birth control during the study

• fluent in english

Exclusion Criteria:

• No emergent serious medical issues:

• cardiovascular disease

• neurological illnesses including -

• severe head injury

• HIV infection

• liver disease

• blood diseases

• kidney disease

• No drugs of abuse

• Not pregnant

• Not able to fast

• History of severe head injury