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NCT01555021 · ClinicalTrials.gov registry record
Pharmacogenomics for Antidepressant Guidance and Education
A clinical trial, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- 4
- Enrollment target
NCT01555021: Clinical Trial study, sponsored by Massachusetts General Hospital.
NCT01555021 is a clinical trial that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 4 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01555021 was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- 4 participants
- Enrollment target
Study Summary
More than one out of three individuals treated for major depressive disorder (MDD) do not experience a full reduction of symptoms even when treated with adequate antidepressant medication. These individuals may have treatment-resistant depression. This is a condition that contributes to the tremendous costs of MDD, in terms of health care costs, functional impairment (limitation of an individual's functional ability), and diminished quality of life. There is a clear need for personalized medicine, for people at high risk for treatment-resistant depression. If these individuals could be identified early in the course of their depression, they could be recommended for more intensive or specialized interventions. Doing so could improve their likelihood of having a full reduction in their symptoms. Today, there are many treatment options for MDD. Individuals can spend months or years in and out of treatment before receiving one that works for their treatment-resistant depression. The investigators want to study treatment resistant depression by examining specific genes (genotyping) that might influence how your body responds to certain antidepressant medications. This process of examining specific genes is not experimental. To look at your specific genes, the investigators will collect a blood sample. Genes contain the material passed from parent to child that determines the make-up of the body and mind. For example, some genes control the color of your hair or eyes. Genes are contained in your DNA (deoxyribonucleic acid). There are many differences in DNA, from one person to another. These differences may affect a person's chances of having a particular disease.
Primary Outcome
To determine the efficacy of assay-guided treatment (AGT) versus treatment-as-usual (TAU), in terms of depression severity as measured by change in the Quick Inventory of Depressive Symptoms (QIDS-SR 16), adjusted for baseline severity, upon discharge, and at 1, 3, and 6 months post discharge from inpatient treatment. The QUIDS-SR 16 is a self rating 16 item multiple-choice questionnaire that measure severity of depression over the past week. The range on the QIDS-SR IS 0-27, with 0-5 indicating
Interventions
- GENETIC Genotyping assays
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2011-12 |
| Est. Completion | 2012-07 |
Why NCT01555021 stopped before completion
NCT01555021 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 4 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Genotyping assays is the first listed.
NCT01555021 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01555021 about?
NCT01555021 is a clinical study titled "Pharmacogenomics for Antidepressant Guidance and Education". More than one out of three individuals treated for major depressive disorder (MDD) do not experience a full reduction of symptoms even when treated with adequate antidepressant medication. These individuals may have treatment-resistant depression. This is a condition that contributes to the tremendo...
What is the current status of trial NCT01555021?
This trial is currently terminated. The enrollment target is 4 participants. The study started on 2011-12. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01555021?
The interventions under investigation include: Genotyping assays (GENETIC).
Who is sponsoring clinical trial NCT01555021?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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