Ignite Creation Date:
2024-05-05 @ 11:50 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01426516
Status:
TERMINATED
Last Update Posted:
2021-09-13
First Post:
2011-08-29
Brief Title:
Pharmacogenomics for Antidepressant Guidance and Education 1 PAGE-1_AG1
Sponsor:
Genomind LLC
Organization:
Genomind LLC
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Invalid data collection
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAGE-1_AG1
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None