Originally published May 15.
At the American Psychiatric Association annual meeting last week, personalized medicine-focused firm Genomind outlined plans for using online informed consent forms and surveys to efficiently conduct studies involving its Genecept Assay.
Genomind is planning to conduct open-label studies to gauge whether its test can inform treatment decisions and improve outcomes for patients with depression, anxiety, biopolar disorder, and schizophrenia.
The Genecept Assay analyzes genetic markers in patients' saliva and gauges which treatments they are likely to respond to. Genomind claims the test can be used "for a range of psychiatric conditions," including depression, bipolar disorder, schizophrenia, anxiety disorders, obsessive compulsive disorder, and attention deficit hyperactivity disorder."
According to the company's website, the test gauges a number of gene markers that are implicated in the serotonin transporter, the gated calcium channel, the dopamine receptor, the catechol methyl transferase, as well as the MTHFR, CYP2D6, and CYP2C19 enzymes.
In order to recruit patients, Genomind plans to direct potential participants to complete web-based informed consent documents. The company will send e-mail or texts reminding potential subjects to complete online surveys.
"This study design offers a novel paradigm to quickly operationalize a clinical trial through electronic informed consent and survey collection, and it will serve as a model for additional disease specific trials," Genomind researchers and collaborators said in a poster presented at the APA conference. Genomind is hoping that the study will show that its test inspires changes in physicians' prescribing patterns, inspires patient compliance with medications, improves patient outcomes, and incurs cost savings to the healthcare system.
Clinicians will complete an online questionnaire to catalog their patients' symptoms and any changes in their condition three months after the baseline evaluation and after receiving treatment based on Genecept test results.
Patient participants, meanwhile, will complete online questionnaires regarding their symptoms and quality of life at baseline, and at one-month and three-month intervals post-treatment. Through these online surveys, "patients will also be able to report any side effects experienced, as well as their level of overall satisfaction with treatment," Genomind said in a statement.
The studies will aim to assess the effectiveness of treatments when they are guided by Genecept. The efficacy of the test will be measured by the Clinical Global Impressions scale and by the Quick Inventory of Depressive Symtomatology Self Report.
The researchers will try to characterize for which patients the tested genes are informative; investigate whether the gene variants being tested are associated with response to treatments or classes of treatments; and assesses whether the test-guided clinical strategies reduce adverse events in patients.
"Genetic testing has been employed in fields such as oncology and anticoagulation, but less commonly in psychiatry," Stephen Stahl, a psychiatry professor at the University of California, San Diego, and a member of Genomind's scientific advisory board, said in a statement. "The study is a simple, nonintrusive methodology that will enable us to collect and share the first-hand experiences that our clinicians and their patients have had with the Genecept Assay."
The company plans to recruit 100 patients in the depression study by the third quarter of this year, and reach a cohort size of more than 1,300 patients by the end of 2013. By the end of next year, Genomind is hoping to involve 150 patients in the anxiety study, 60 patients in the bipolar disorder study, and 30 patients in the schizophrenia study.
Separate from these trials, the Massachusetts General Hospital launched an inpatient study in February comparing treatment-as-usual against Genecept-guided treatment in adults with treatment-resistant depression. Additionally, Genomind and community-based behavioral healthcare provider Centerstone are collaborating on an outpatient pilot trial looking at how useful genetic biomarker data is in helping doctors select the right treatment for patients with major depressive disorder.