A Pharmacokinetic/Pharmacodynamic Genetic Variation Treatment Algorithm Versus Treatment As Usual for Management of Depression
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depression
- Sponsor
- Mayo Clinic
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Change in depression as measured by the Quick Inventory of Depressive Symptoms (QIDS-C16)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The overall goal of this investigator-initiated trial is to evaluate the treatment outcome of depression utilizing platform algorithm products that can allow rapid identification of pharmacokinetic (PK) and/or pharmacodynamic (PD) genomic variation. This new technology may have the potential to optimize treatment selection by improving response, minimizing unfavorable adverse events / side effects and increasing treatment adherence.
Detailed Description
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.
Investigators
Mark Frye
Chair-Psychiatry/Psychology
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •Age 18-65, male or female, any race/ethnicity
- •Mayo Clinic Depression Center inpatient or outpatient, or an outpatient of Mayo Clinic Rochester and satellite clinics, and outpatients from Mayo Clinic Health System clinics
- •Ability to provide informed consent
- •Structured Clinical Interview (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 \[8\]
- •Current index episode having not been treated with psychotropic medications or inadequately responsive to treatment (IRT). IRT defined as intolerability, adverse event, or inadequate efficacy of current psychotropic medication (at least 4 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 serum or urine pregnancy test (or history of hysterectomy)
- •Negative urine toxicology test (will only be completed at the request of the treating clinician).
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 \& baseline visit with exception of no more than 8mg of Ativan within a 24-hour period.
- •Patients who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria for any significant current substance use disorder other than nicotine or caffeine. Must have at least early, partial or full, remission X 3 months
- •Clinically diagnosed cannabis use disorder, or SCID confirmed cannabis abuse or dependence.
- •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
Outcomes
Primary Outcomes
Change in depression as measured by the Quick Inventory of Depressive Symptoms (QIDS-C16)
Time Frame: baseline, 8 weeks
The QIDS-C16 is a 16-item scale that is clinician-rated; it is designed to assess the severity of depressive symptoms. The QIDS-C16 total score ranges from 0-27. Scores ranging from 0 to 10 correspond with no to mild depression, while scores \>/= 11 correspond to moderate to severe depression. A negative change indicates improvement in the subject's depression, and a positive change indicates a worsening of the subject's depression.
Secondary Outcomes
- Number of subjects with improvement of depressive symptoms as shown by a score <6 on QIDS-C16(8 weeks)
- Number of subjects with improvement of depressive symptoms as shown by 50% reduction in QIDS-C16 score(8 weeks)
- Improvement of depressive symptoms as shown by the Hamilton Rating Scale for Depression (HAMD-17)(8 weeks)
- Improvement of depressive symptoms(8 weeks)
- Number of subjects with improvement of depressive symptoms as shown by score of "much" or "very much improved" on Clinical Global Impression - Improvement Scale(8 weeks)