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NCT03751280 · ClinicalTrials.gov registry record · Phase 2
Study of Efficacy of PEAR-004 in Schizophrenia
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 112
- Enrollment target
NCT03751280: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT03751280 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 112 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03751280, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 112 participants
- Enrollment target
Study Summary
The purpose of the study was to determine in patients currently being administered antipsychotic pharmacotherapy whether PEAR-004 could further reduce symptoms of schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS). The overall rationale for the study was to assess the first prescription digital therapeutic (PDT) in schizophrenia using a form of proven psychosocial intervention, cognitive behavioral therapy (CBT), to supplement standard of care with antipsychotic medications.
Primary Outcome
The Positive and Negative Syndrome Scale (PANSS) is a well validated, standardized method of evaluating and monitoring psychotic symptoms. The PANSS assesses: positive (hallucinations, delusions, thought disorder), negative (blunted affect, abstract thinking and general symptomatology. The positive and negative subscale each consist of 7 items rated from 1(absent) - 7(extreme) with a minimum score = 7, maximum score = 49. The general subscale consists of 16 items with a minimum score = 16, maxim
Interventions
- DEVICE Sham
- DEVICE PEAR-004
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2018-12-10 |
| Est. Completion | 2019-09-26 |
| Phase | Phase 2 |
What the finished NCT03751280 record still lists
NCT03751280 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (16% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham is the first listed.
NCT03751280 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03751280 about?
NCT03751280 is a clinical study titled "Study of Efficacy of PEAR-004 in Schizophrenia". The purpose of the study was to determine in patients currently being administered antipsychotic pharmacotherapy whether PEAR-004 could further reduce symptoms of schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS). The overall rationale for the study was to assess the fir...
What is the current status of trial NCT03751280?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 112 participants. The study started on 2018-12-10. Estimated completion is 2019-09-26.
What interventions are being tested in trial NCT03751280?
The interventions under investigation include: Sham (DEVICE), PEAR-004 (DEVICE).
Who is sponsoring clinical trial NCT03751280?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03751280's enrollment target sits among peer trials
112 631st of 2000 higher than 1,369 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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