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NCT01407094 · ClinicalTrials.gov registry record · Phase 2
Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care for Depression
A Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 296
- Enrollment target
NCT01407094: Completed Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
NCT01407094 is a Phase 2 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 296 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (123% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01407094, a Phase 2 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 296 participants
- Enrollment target
Study Summary
This study will examine multiple carefully selected clinical and biological markers, using both existing state-of-the-art technologies as well as pioneering, innovative approaches. The study is designed to identify moderators and mediators of treatment response for depression in order to specify a biosignature of treatment response for depression. Evaluation of the usefulness of these markers in a carefully conducted clinical trial comparing an antidepressant to placebo will assist in developing a Depression Treatment Response Index (DTRI) to help clinicians match treatments to patients with MDD, resulting in timely selection of treatments best suited for individual patients and thus approaching personalized treatment. The resulting index provides a truly novel means of synthesizing the contribution of key clinical and biological parameters in an easy to use tool for clinical care.
Primary Outcome
The Hamilton Rating Scale for depression is a measure of depressive severity (HAM-D17; HDRS) * Scores range from 0-52 * Lower scores indicate less depressive symptomatology, and so are the more desirable.
Interventions
- DRUG Placebo
- DRUG Sertraline
- DRUG BupropionXL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 296 participants |
| Start Date | 2011-07-29 |
| Est. Completion | 2016-04 |
| Phase | Phase 2 |
What the finished NCT01407094 record still lists
NCT01407094 is an interventional study that assigns participants to a tested intervention. The registered 296 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (123% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01407094 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01407094 about?
NCT01407094 is a clinical study titled "Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care for Depression". This study will examine multiple carefully selected clinical and biological markers, using both existing state-of-the-art technologies as well as pioneering, innovative approaches. The study is designed to identify moderators and mediators of treatment response for depression in order to specify a b...
What is the current status of trial NCT01407094?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 296 participants. The study started on 2011-07-29. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01407094?
The interventions under investigation include: Placebo (DRUG), Sertraline (DRUG), BupropionXL (DRUG).
Who is sponsoring clinical trial NCT01407094?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01407094's enrollment target sits among peer trials
296 189th of 2000 higher than 1,812 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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