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

Completed · Not applicable

Conditions studied: Depression, Mood Disorder, Bipolar

In brief

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.

Key facts

Study ID

NCT02189057

Run by

Mayo Clinic

People needed

160

Starts

2014-11-01

Expected to finish

2018-10-19

Last updated by the study team

2018-10-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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
• Significant unstable medical condition
• Hepatic insufficiency (2.5 X upper limit of normal (ULN) for Aspartate Aminotransferase (AST) or Alanine Aminotransferase (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
• Known cytochrome (CYP) \& serotonin transporter genomic testing results within 5 years
• A score of ≥15 on the Young Mania Rating Scale (YMRS)

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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