Schizophrenia Clinical Trial
Official title:
Prospective Cytochrome P450 Genotyping and Clinical Outcomes in Patients With Psychosis
Verified date | August 2018 |
Source | Northwell Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 88 |
Est. completion date | July 31, 2018 |
Est. primary completion date | July 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. Age 18-60; 2. DSM-IV(Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychotic disorder NOS (Not otherwise specified), bipolar disorder with psychotic features 3. Having moderate to severe psychotic symptoms resulting in inpatient admission 4. Able to provide informed consent Exclusion Criteria: 1. Evidence of serious medical conditions, 2. Evidence of liver disease, as shown in elevated liver function test 3. Female patients who are pregnant or breast feeding; 4. History of allergic reactions to risperidone or Invega; 5. History of risperidone or Invega treatment failure. 6. History of receiving any long-acting injectable form of antipsychotic medications such as haloperidol decanoate, fluphenazine decanoate, Risperdal Consta, Invega Sustenna, and Zyprexa IntraMuscular in the past two months. 7. History of treatment with clozapine. 8. Medications that potentially interfere with the CYP450 2D9 enzyme family, including bupropion, fluoxetine, paroxetine, duloxetine, sertraline, cinacalcet, quinidine, terbinafine, amiodarone, and cimetidine, and as per clinical review by study physicians. 9. Patients who are not able to provide informed consent due to impairment in decision-making capacity. |
Country | Name | City | State |
---|---|---|---|
United States | Zucker Hillside Hospital | Glen Oaks | New York |
Lead Sponsor | Collaborator |
---|---|
Northwell Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of days before discontinuation | 6 weeks, discontinuation or discharge up to 6 weeks | ||
Other | Days of Inpatient Stay | 6 weeks, discontinuation or discharge up to 6 weeks | ||
Primary | Efficacy | Scores on: Schedule for Assessment of Negative Symptoms (SANS) Brief Psychiatric Rating Scale (BPRS) Global Impression - Improvement scale (CGI-I) |
6 weeks or discharge up to 6 weeks | |
Secondary | Adverse Drug Effects | As measured by: Hillside Hospital Adverse Events Rating Scale Abnormal Involuntary Movement Scale (AIMS) Barnes Rating Scale for Drug-Induced Akathisia Simpson-Angus Rating Scale for Extrapyramidal symptoms |
6 weeks, discharge or discontinuation up to 6 weeks |
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