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Nicotinic Receptors and Schizophrenia

NCT02538081 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2017-05-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Risperidone plus Placebo

Standard of care including Risperidone plus Placebo

DRUG

Risperidone plus DMXB-A

Standard of care including Risperidone plus DMXB-A

Sponsors & Collaborators

  • University of Colorado, Denver

    collaborator OTHER

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Robert Freedman, MD · VA Eastern Colorado Health Care System, Denver, CO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02538081 on ClinicalTrials.gov