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NCT01031810 · ClinicalTrials.gov registry record · Phase 4
PET Biomarkers in Treatment Resistant Depression
A Phase 4 study, sponsored by New York State Psychiatric Institute.
- Terminated
- Registry status
- Phase 4
- Development phase
- 13
- Enrollment target
NCT01031810: Clinical Trial Phase 4 study, sponsored by New York State Psychiatric Institute.
NCT01031810 is a Phase 4 study that was terminated before completion, run by New York State Psychiatric Institute. The registered enrollment target is 13 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01031810, a Phase 4 study, was terminated before completion, sponsored by New York State Psychiatric Institute.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 13 participants
- Enrollment target
Study Summary
The primary objectives of the study are to test whether brain Mono Amine Oxidase-A (MAO-A) levels are elevated in patients with treatment-resistant major depression, and to explore whether MAO-A brain levels predict treatment outcome with Mono Amine Oxidase Inhibitor (MAOI) medication in this population.
Primary Outcome
HAM-D is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. Each item on the questionnaire is scored on a 3 or 5 point scale, depending on the item, and the total score is compared to the corresponding descriptor. Scale range (0-52): A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial.
Interventions
- DRUG tranylcypromine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2009-11 |
| Est. Completion | 2013-03 |
| Phase | Phase 4 |
Why NCT01031810 stopped before completion
NCT01031810 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which tranylcypromine is the first listed.
NCT01031810 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01031810 about?
NCT01031810 is a clinical study titled "PET Biomarkers in Treatment Resistant Depression". The primary objectives of the study are to test whether brain Mono Amine Oxidase-A (MAO-A) levels are elevated in patients with treatment-resistant major depression, and to explore whether MAO-A brain levels predict treatment outcome with Mono Amine Oxidase Inhibitor (MAOI) medication in this popula...
What is the current status of trial NCT01031810?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 13 participants. The study started on 2009-11. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01031810?
The interventions under investigation include: tranylcypromine (DRUG).
Who is sponsoring clinical trial NCT01031810?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01031810's enrollment target sits among peer trials
13 1910th of 2000 higher than 88 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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