Pharmacogenomics for Antidepressant Guidance and Education 1 (PAGE-1_AG1)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
|Official Title:||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|
- Efficacy measured by change in Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), adjusted for baseline severity, at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
To determine the efficacy of assay-guided treatment (AGT) versus treatment-as-usual (TAU), in terms of depression severity as measured by change in Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), adjusted for baseline severity, at 6 months
- highest score on any 1 of the 4 sleep items (items 1 to 4)
- highest score on any 1 of the 4 weight items (items 6 to 9)
- highest score on either of the 2 psychomotor items (15 and 16)
- scores for each of the 6 MDD symptom domains
Total scores range from 0-27
- Clinician Behavior as measured by change in recorded treatment choice before and after the assay results are made available. [ Time Frame: one week ] [ Designated as safety issue: No ]Clinicians will rank first and alternative treatment choice and dosage prior to assay and first and two alternative treatment choices after receiving assay results (for AGT group). Clinician choices will be compared.
- Quality of Life as measured by self reported assessment of Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ) [ Time Frame: baseline, 3, 6 months ] [ Designated as safety issue: No ]To determine the efficacy of assay-guided treatment (AGT) versus treatment-as-usual (TAU) in outpatient treatment of nonpsychotic major depressive disorder, in terms of patient quality of life (Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)) The minimum raw score on the QLESQ is 14, and the maximum score is 70.
- Cost [ Time Frame: 6 months ] [ Designated as safety issue: No ]To compare costs of AGT versus TAU in outpatient treatment of nonpsychotic major depressive disorder as measured by claims data.
- Acceptability of the use of AGT for Subjects and Clinicians as measured by satisfaction survey [ Time Frame: 6 months ] [ Designated as safety issue: No ]To determine the acceptability to patients and clinicians of assay-guided treatment (AGT) versus treatment-as-usual (TAU) in outpatient treatment of nonpsychotic major depressive disorder
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
No Intervention: Treatment as usual (TAU)
Subjects will give DNA sample for genetic testing but will not receive genetic results and will therefore receive treatment as usual.
Experimental: Genecept Assay
Subjects donate DNA sample for genetic testing and treatment decisions take genetic results into account.
Device: Genecept Assay
Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders
Other Name: Genetic Test
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426516
|Contact: Rachel Dicker, PharmD||215-396-5594||Rachel.Dicker@genomind.com|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37228|
|Contact: Vivian Park, MS|
|Principal Investigator: Karen Rhea, MD, FAPA, FAAP|
|Study Director:||Rachel Dicker, PharmD||Genomind, LLC|