NCT01426516

Pharmacogenomics for Antidepressant Guidance and Education 1 (PAGE-1_AG1)

A Six-month Study of the Genecept Assay vs. Treatment as Usual to Evaluate Efficacy of Using Assay Guided Treatment in Outpatient Adults With Treatment Resistant Depression

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Genomind, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

One-third or more of individuals treated for major depressive disorder (MDD) do not experience remission of symptoms despite at least two adequate antidepressant trials. Such treatment-resistant depression (TRD) contributes disproportionately to the tremendous costs of MDD, in terms of health care costs, functional impairment, and diminished quality of life. The promise of personalized medicine for individuals at high risk for TRD is apparent. If these individuals could be recognized early in their disease course, they could be triaged to more intensive or targeted interventions to improve their likelihood of remission. With the proliferation of treatment options in MDD, at present individuals can spend months or years in and out of treatment before receiving these next-step treatments. At present, no clinical or biomarker-based tool has been shown to assist in matching patients with treatments most likely to be effective for them. The Genecept Assay offers the possibility of "Personalized Medicine" in psychiatry. Clinicians may find this additional genetic information can lead to optimized treatment plans for individual patients. Before such an assay can be widely applied clinically, it is necessary to demonstrate that this tool usefully impacts treatment outcomes. This study will examine the potential impact of the assay in terms of depression severity at 3 months, with further follow-up out to 6 months. Secondary measures will allow an estimate of its potential to change clinician behavior and improve patient quality of life. Further measures will also allow for refinement of the assay to maximize patient and clinician satisfaction, and estimate the potential savings associated with deployment of this assay in real-world clinical settings.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DEVICE	Genecept Assay	Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders

Timeline

• Start date: 2011-09-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2011-08-31
• Last updated: 2021-09-13
• Results posted: 2015-11-30

Locations

1 site across 1 country: United States