Nicotinic Receptors and Schizophrenia

Withdrawn before enrolling · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT02538081

Run by

VA Office of Research and Development

People needed

0

Starts

2015-08-01

Expected to finish

2016-08-01

Last updated by the study team

2017-05-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• VA Eastern Colorado Health Care System, Denver, CO — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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