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NCT01426516 · ClinicalTrials.gov registry record · NA
Pharmacogenomics for Antidepressant Guidance and Education 1 (PAGE-1_AG1)
A NA study, sponsored by Genomind.
- Terminated
- Registry status
- NA
- Development phase
- 29
- Enrollment target
NCT01426516 is a NA study that was terminated before completion, run by Genomind. The registered enrollment target is 29 participants.
The verdict
NCT01426516, a NA study, was terminated before completion, sponsored by Genomind.
- TERMINATED
- Registry status
- NA
- Development phase
- 29 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Genecept Assay
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2011-09 |
| Est. Completion | 2014-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01426516
The ClinicalTrials.gov registry entry for NCT01426516 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genomind, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Genecept Assay is the first listed.
NCT01426516 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01426516 about?
NCT01426516 is a clinical study titled "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 c...
What is the current status of trial NCT01426516?
This trial is currently terminated. It is a NA study. The enrollment target is 29 participants. The study started on 2011-09. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01426516?
The interventions under investigation include: Genecept Assay (DEVICE).
Who is sponsoring clinical trial NCT01426516?
This trial is sponsored by Genomind, which has 3 total clinical trials registered on ClinicalTrials.gov.
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