Clinical Utility of Pharmacogenomics of Psychotropic Medications

Withdrawn before enrolling · Phase 4

Conditions studied: Psychiatric Disorders, Pain

In brief

While the scientific understanding of pharmacogenomics is quickly accelerating, its translation to clinical decision-making (especially in psychiatric practice) has progressed more slowly. In an effort to begin to bridge this translational gap, genetic testing has been developed for various and commonly existing psychiatric disorders, such as major depression, schizophrenia, bipolar disorder, and pain syndromes to improve the safety of prescribing psychotropic medications for these disorders. This genetic testing incudes several pharmacodynamics and pharmacokinetic genetic factors, such as the cytochrome P450 1A2 gene (CYP1A2); the cytochrome P450 2B6 (CYP2B6) gene; P450 2D6 gene (CYP2D6); the cytochrome P450 2C9 gene (CYP2C9); the cytochrome P450 2C19 gene (CYP2C19); uridine-glucoronyl-transferase 2B15 (UGT2B15) gene; the serotonin transporter gene (Solute Carrier Family 6 Member; SLC6A4); p-glycoprotein ( ATP-binding cassette sub-family B member 1; ABCB1) transporter gene; the serotonin 2A receptor gene (HTR2A); the serotonin 2C receptor (HTR2C) gene; serotonin 1a receptor (5HT1a) gene; dopamine 1 receptor (DRD1) gene; dopamine 2 receptor (DRD2) gene; adrenergic alpha-2A receptor (alpha-2A) gene; opioid mu (opioid receptor mu 1; OPRM1) receptor gene; dopamine synthesis gene (ankyrin repeat and kinase domain containing 1; ANKK1); dopamine metabolizing enzyme \[Catechol-o-methyltransferase (COMT\]) gene; kainite receptor gene (glutamate ionotropic receptor kainate type subunit 4; GRIK4); folate (methylenetetrahydrofolate reductase; MTHFR) gene; sodium channels (sodium voltage-gated channel alpha subunit 2; SCN2A) gene. The interpretive report is based on copies of these multiple informative genes. The investigators are proposing to utilize comprehensive genetic testing to select more genetically-informed psychotropic medications to enhance their effectiveness in real-world patients with psychiatric illnesses such as schizophrenia, major depression, bipolar affective disorder as well as pain in a state hospital setting. The investigators plan to use genetic testing offered by Admera® for major classes of psychotropic medications. The investigators hypothesize that genetic testing will demonstrate clinical benefits by improving state hospital patients' response and decreasing their adverse effects. The proposed study will be conducted in a total sample of 60 subjects diagnosed with schizophrenia, major depression, bipolar affective disorder as well as pain at the Oregon State Hospital, Salem Oregon over a total period of 24 months

Key facts

Study ID

NCT03907124

Run by

Oregon Health and Science University

People needed

0

Starts

2019-06-03

Expected to finish

2021-07-09

Last updated by the study team

2023-09-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is between the ages of 18 and 80
• Schizophrenia or schizoaffective disorder, major depressive disorder, bipolar affective disorder as ascertained by a qualified physician or mental health professional licensed to diagnose based on DSM-V criteria.
• Patients using antidepressants, anxiolytics, mood stabilizers, and sedative/hypnotics will be allowed
• Patients on clozapine treatment will be allowed.
• Study subjects with a score of at least 12 on the scale to assess capacity to consent i.e., UBACC.

You may not qualify if…

• Patients who are court-committed for involuntary medications
• Uncontrolled and/or serious medical illness (as ascertained at admission screening process)
• Pregnant patients
• Patients who cannot communicate in English.

Where it is running

• Mujeeb Uddin Shad — Salem, Oregon, United States

Full record on ClinicalTrials.gov

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