MedTrace Logo

Prospective Cytochrome P450 Genotyping and Clinical Outcomes in Patients With Psychosis

NCT01878513 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2018-08-27

No results posted yet for this study

Summary

The aim of the study is to examine whether determining treatment strategies based upon Cytochrome P450 2D6 (CYP2D6) genotype will improve drug response rates and clinical outcome in patients with psychosis.

The investigators predict that prospectively testing CYP2D6 genotype and using this information to treat psychotic patients with risperidone will improve clinical outcomes. Specifically, CYP2D6 poor metabolizers who are treated with low dose and slow titration of risperidone will do better than those who are treated with usual dose and titration approach in terms of rates of side effects and clinical improvement.

Conditions

  • Schizophrenia
  • Schizoaffective Disorder
  • Psychotic Disorder Not Otherwise Specified
  • Severe Bipolar Disorder With Psychotic Features

Interventions

DRUG

risperidone

3 levels of dosing dependent on which condition a patient is assigned to.

Sponsors & Collaborators

  • Northwell Health

    lead OTHER

Principal Investigators

  • Jianping Zhang, MD, PhD · Zucker Hillside Hospital, Division of Psychiatry Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-09-23
Primary Completion
2018-07-31
Completion
2018-07-31

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 NCT01878513 on ClinicalTrials.gov