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NCT03817528 · ClinicalTrials.gov registry record · Phase 2
ITI-007 (Lumateperone Tosylate) for Schizophrenia
A Phase 2 study, sponsored by New York State Psychiatric Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT03817528: Clinical Trial Phase 2 study, sponsored by New York State Psychiatric Institute.
NCT03817528 is a Phase 2 study that was terminated before completion, run by New York State Psychiatric Institute. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03817528, a Phase 2 study, was terminated before completion, sponsored by New York State Psychiatric Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study Summary
The purpose of this study is to offer open label ITI-007 treatment to patients who poorly respond or poorly tolerate approved medications.
Primary Outcome
schizophrenia symptoms will be measures using the Positive and Negative Symptom Scale (PANSS) Total PANSS score (range: 30-210). Individual items scored from 1(absent) to 7 (extremely severe). Total PANSS score is sum of the 30 individual items with lowest score (30) indicating all symptoms absent and the maximum score (210) indicating all symptoms rated as extremely severe.
Interventions
- DRUG ITI-007
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2019-03-01 |
| Est. Completion | 2020-09-23 |
| Phase | Phase 2 |
Why NCT03817528 stopped before completion
NCT03817528 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which ITI-007 is the first listed.
NCT03817528 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03817528 about?
NCT03817528 is a clinical study titled "ITI-007 (Lumateperone Tosylate) for Schizophrenia". The purpose of this study is to offer open label ITI-007 treatment to patients who poorly respond or poorly tolerate approved medications.
What is the current status of trial NCT03817528?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2019-03-01. Estimated completion is 2020-09-23.
What interventions are being tested in trial NCT03817528?
The interventions under investigation include: ITI-007 (DRUG).
Who is sponsoring clinical trial NCT03817528?
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 NCT03817528's enrollment target sits among peer trials
4 2001st of 2000 the lowest 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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