Prospective Cytochrome P450 Genotyping and Clinical Outcomes in Patients With Psychosis
Completed · Not applicable
Conditions studied: Schizophrenia, Schizoaffective Disorder, Psychotic Disorder Not Otherwise Specified, Severe Bipolar Disorder With Psychotic Features
In brief
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.
Key facts
- Study ID
- NCT01878513
- Run by
- Northwell Health
- People needed
- 88
- Starts
- 2009-09-23
- Expected to finish
- 2018-07-31
- Last updated by the study team
- 2018-08-27
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18-60;
- 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
- Having moderate to severe psychotic symptoms resulting in inpatient admission
- Able to provide informed consent
You may not qualify if…
- Evidence of serious medical conditions,
- Evidence of liver disease, as shown in elevated liver function test
- Female patients who are pregnant or breast feeding;
- History of allergic reactions to risperidone or Invega;
- History of risperidone or Invega treatment failure.
- 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.
- History of treatment with clozapine.
- 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.
- Patients who are not able to provide informed consent due to impairment in decision-making capacity.
Where it is running
- Zucker Hillside Hospital — Glen Oaks, New York, United States
Full record on ClinicalTrials.gov
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