NCT02566057

Brief Summary

This study evaluates whether prospective pharmacogenetic testing is cost-effective in affecting clinical treatment outcomes in patients with early-phase psychosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

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

July 10, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

January 24, 2018

Status Verified

January 1, 2018

Enrollment Period

3.5 years

First QC Date

September 30, 2015

Last Update Submit

January 22, 2018

Conditions

SchizophreniaSchizoaffective DisorderSchizophreniform DisorderPsychotic DisordersBipolar Disorder

Outcome Measures

Primary Outcomes (1)

  • Time to Discontinuation of First Medication

    Due to lack of efficacy or intolerability

    12 months

Secondary Outcomes (1)

  • Prescribing Behavior Change Based on the Results of the Pharmacogenetic Testing

    12 months

Other Outcomes (3)

  • Treatment Efficacy

    12 months

  • Adverse Drug Response

    12 months

  • Treatment Services Utilized

    12 months

Study Arms (2)

PGx testing guided treatment (PGT)

EXPERIMENTAL

Results of the GeneceptTM Assay will be provided to their prescribers who may use the knowledge to guide medication management.

Biological: PGx testing guided treatment (PGT)

Treatment as usual condition (TAU)

NO INTERVENTION

Patients will also utilize the GeneceptTM Assay but the results will not be provided back to their prescribers, who will treat the patients without the knowledge of pharmacogenetic testing results.

Interventions

PGx testing guided treatment (PGT)BIOLOGICAL

Genecept Assay (GeneceptTM Assay) will provide information on genotypes of genetic variants that are relevant to psychiatric drug response. The provider can use the information to decide on which psychotropic drugs to use.

PGx testing guided treatment (PGT)

Eligibility Criteria

Age15 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 15-64;
  • Diagnostic and Statistical Manual Diploma in Social Medicine diagnosis of schizophrenia (DSM IV), schizoaffective disorder, schizophreniform disorder, psychotic disorder NOS, and bipolar disorder;
  • Onset of antipsychotic treatment within the past 3 years;
  • Able to provide informed consent. (assent for those under age 18)

You may not qualify if:

  • Evidence of serious medical conditions,
  • Female patients who are pregnant or breast feeding;
  • Patients who are not willing to take medications for treatment;
  • Patients who are unable to provide informed consent due to impairment in decision-making ability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zucker Hillside Hospital-North Shore Long Island Jewish Health System

Glen Oaks, New York, 11004, United States

Location

Related Publications (2)

  • Malhotra AK, Zhang JP, Lencz T. Pharmacogenetics in psychiatry: translating research into clinical practice. Mol Psychiatry. 2012 Jul;17(8):760-9. doi: 10.1038/mp.2011.146. Epub 2011 Nov 15.

    PMID: 22083729BACKGROUND

  • Zhang JP, Malhotra AK. Pharmacogenetics and antipsychotics: therapeutic efficacy and side effects prediction. Expert Opin Drug Metab Toxicol. 2011 Jan;7(1):9-37. doi: 10.1517/17425255.2011.532787.

    PMID: 21162693BACKGROUND

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersBipolar Disorder

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood Disorders

Study Officials

  • Jianping Zhang, MD, PhD

    Psychiatrist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychiatrist

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 1, 2015

Study Start

July 10, 2014

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

January 24, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)