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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  1. Age 18-65, male or female, any race/ethnicity
  2. Mayo Clinic Depression Center inpatient or outpatient
  3. Ability to provide informed consent
  4. SCID confirmed major depressive episode associated with Major Depressive Disorder, Bipolar I/II disorder, or Schizoaffective Bipolar Disorder
  5. Current index episode of major depression < 2 years duration
  6. Moderate symptom severity defined by HAMD-17 rating scale score ≥ 17 [8]
  7. Current index episode inadequately responsive to treatment (IRT). IRT defined as intolerability, adverse event, or inadequate efficacy of current psychotropic medications (at least 4 weeks duration)
  8. 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
  9. Negative serum or urine pregnancy test (or history of hysterectomy)
  10. Negative urine toxicology test (will only be completed at the request of the treating clinician).

Exclusion Criteria:

  1. Inability to speak English
  2. Inability or lack of willingness to provide informed consent
  3. Axis I or II disorder other than depression (i.e., by clinical assessment) that is the primary reason for treatment
  4. Psychotropic medication change (including dosage) between screening & baseline visit with exception of no more than 8mg of Ativan within a 24-hour period.
  5. 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
  6. Current clinical diagnosis delirium, dementia, other cognitive disorders, or non-mood psychotic disorder (i.e., schizophrenia, delusional disorder)
  7. Index episode symptoms of hallucinations or delusions
  8. Serious suicidal risk and/or in need of immediate hospitalization as judged by the investigator
  9. History of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic for 6 months
  10. Significant unstable medical condition
  11. Hepatic insufficiency (2.5 X ULN for AST or ALT), past liver transplant recipient, and/or clinical diagnosis of cirrhosis of the liver
  12. 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
  13. Participation in another clinical trial within 30 days of the screening visit
  14. Anticipated inability to attend scheduled study visits
  15. Patients who in the judgment of the Investigator may be unreliable or uncooperative with the evaluation procedure outlined in this protocol
  16. Known cytochrome (CYP) & serotonin transporter genomic testing results within 5 years
  17. A score of ≥15 on the YMRS

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mark Frye, M.D.

Closed for enrollment

Contact information:

Jose Rico CCRP

(507)293-5268

Rico.Jose@mayo.edu

Austin, Minn.

Mayo Clinic principal investigator

Mark Frye, M.D.

Closed for enrollment

Contact information:

Jose Rico CCRP

(507)293-5268

Rico.Jose@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20117960

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