NCT02538081

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 2, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

August 10, 2015

Last Update Submit

May 25, 2017

Conditions

Schizophrenia

Keywords

schizophreniaolanzapinerisperidonealpha 7 nicotinic receptorscognition

Outcome Measures

Primary Outcomes (2)

  • Change in Attention due to DMXB-A

    the difference in the attention index from the RBANS measured at 6 weeks between risperidone plus DMXB-A and risperidone plus placebo

    measured at 6 weeks

  • Change in Executive Function due to DMXB-A

    the difference in the executive function index from the RBANS measured at 6 weeks between risperidone plus DMXB-A and risperidone plus placebo

    measured at 6 weeks

Secondary Outcomes (25)

  • Change in LDL

    measured at 6 weeks

  • Change in HDL

    measured at 6 weeks

  • Change in glucose

    measured at 6 weeks

  • Change in Hemoglobin A1C

    measured at 6 weeks

  • Change in insulin levels

    measured at 6 weeks

  • +20 more secondary outcomes

Study Arms (2)

Risperidone plus placebo

ACTIVE COMPARATOR

Risperidone titrated to a dose equivalency of the patients' prior dose of olanzapine plus placebo

Drug: Risperidone plus Placebo

Risperidone plus DMXB-A

ACTIVE COMPARATOR

Risperidone titrated to a dose equivalency of the patients' prior dose of olanzapine plus DMXB-A

Drug: Risperidone plus DMXB-A

Interventions

Risperidone plus PlaceboDRUG

Standard of care including Risperidone plus Placebo

Also known as: Risperdal
Risperidone plus placebo
Risperidone plus DMXB-ADRUG

Standard of care including Risperidone plus DMXB-A

Also known as: Risperdal
Risperidone plus DMXB-A

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \> 25
  • Diagnosis of schizophrenia or schizoaffective disorder
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Eastern Colorado Health Care System, Denver, CO

Denver, Colorado, 80220, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Risperidone3-(2,4-dimethoxybenzylidene)anabaseine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Robert Freedman, MD

    VA Eastern Colorado Health Care System, Denver, CO

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2015

First Posted

September 2, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

May 30, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)