Last updated on February 2018

Pharmacogenomic Decision Support With GeneSight Psychotropic to Guide the Treatment of Schizophrenia/Schizoaffective Disorder

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Schizophrenia | Psychosis
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • 18 years of age or older;
  • Suffer from schizophrenia/schizoaffective disorder meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria;
  • Have a total baseline score on the Brief Psychiatric Rating Scale (BPRS) 45;
  • Be capable and willing to provide written informed consent to participate in this study;
  • Agree to abide by the study protocol and its restrictions and be able to complete all aspects of the study, including all visits and tests

Exclusion Criteria:

  • Patients posing a serious suicidal risk and/or violence as judged by the investigator;
  • Patients with a current Axis I diagnosis of:
  • Delirium
  • Dementia
  • Amnestic and other cognitive disorder;
  • Patients with a history of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic or euthyroid for 6 months;
  • Patients who meet DSM-IV-TR criteria for any significant current substance abuse;
  • Patients with:
  • hepatic insufficiency (three times the upper limit of normal (ULN) for aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)); liver transplant recipient; cirrhosis of the liver;
  • malignancy (except basal cell carcinoma) and/or chemotherapy within 1 year prior to screening; malignancy more than 1 year prior to screening must have been local and without metastasis and/or recurrence, and if treated with chemotherapy, without nervous system complications;
  • significant unstable medical condition or life threatening disease with anticipated survival of less than 6 months;
  • need for therapies that may obscure the results of treatment and/or of the study
  • Participation in another clinical trial within 30 days of the screening visit;
  • Anticipated inability to attend scheduled study visits;
  • Patients who in the judgment of the Investigator may be unreliable or uncooperative with the evaluation procedure outlined in this protocol;
  • Patients with a history of prior pharmacogenomic testing;
  • Any change in psychotropic medication (including change in dosage) between screening and baseline;
  • Patients who are known to be pregnant or lactating;
  • Patients with a history of gastric bypass surgery.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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