A Pharmacokinetic/Pharmacodynamic Genetic Variation Treatment Algorithm Versus Treatment As Usual for Management Of Depression
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 13-007981
NCT ID: NCT02189057
Sponsor Protocol Number: 13-007981
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.
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. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility 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)
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.