A Pharmacokinetic/Pharmacodynamic Genetic Variation Treatment Algorithm Versus Treatment As Usual for Management of Depression


Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

Treatment seeking depressed patients (SCID confirmed major depressive disorder or bipolar I/II disorder) to the Mayo Clinic Depression Center will be invited to participate in this study evaluating the Assurex GeneSight® platform; this new technology can rapidly assess PK and PD genetic variation that can potentially impact antidepressant, antipsychotic, and stimulant associated treatment outcomes for depression. This study will recruit treatment seeking patients with major depression with an index episode of moderate symptom severity that has been unresponsive or poorly tolerated to at least one prior antidepressant treatment. This will be an 8-week, double-blind trial where depressed patients are randomized to testing results of GeneSight® (tricolored clinical report) prior to treatment selection (n=138) vs. treatment as usual (tricolored dummy report) (n=138). All testing results will be made available after the 8-week trial.

Who is eligible to participate?

Inclusion Criteria: - Age 18-65, male or female, any race/ethnicity - Mayo Clinic Depression Center inpatient or outpatient - Ability to provide informed consent - SCID confirmed major depressive episode associated with Major Depressive Disorder, Bipolar I/II disorder, or Schizoaffective Bipolar Disorder - Current index episode of major depression < 2 years duration - Moderate symptom severity defined by HAMD-17 rating scale score ≥ 17 - Current index episode inadequately responsive to treatment (IRT). IRT defined as discontinuation of one or more psychotropic treatments due to intolerability, adverse event, or inadequate efficacy (at least 6 weeks duration) - 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 - Negative urine toxicology screen - Negative serum or urine pregnancy test (or history of hysterectomy) Exclusion Criteria: - Inability to speak English - Inability or lack of willingness to provide informed consent - Axis I or II disorder other than depression (i.e., by clinical assessment) that is the primary reason for treatment - Psychotropic medication change (including dosage) between screening & randomization - Patients who meet DSM-IV-TR criteria for any significant current substance use disorder other than nicotine, caffeine, or cannabis. Must have at least early, partial or full, remission X 3 months - Current clinical diagnosis delirium, dementia, other cognitive disorders, or non-mood psychotic disorder (i.e., schizophrenia, delusional disorder) - Index episode symptoms of hallucinations or delusions - Serious suicidal risk and/or in need of immediate hospitalization as judged by the investigator - History of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic for 6 months - Significant unstable medical condition - Hepatic insufficiency (2.5 X ULN for AST or ALT), past liver transplant recipient, and/or clinical diagnosis of 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 - 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 - Cytochrome (CYP) & serotonin transporter genomic testing within 5 years

Last updated:




IRB Number: