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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 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 112 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03751280
The ClinicalTrials.gov registry entry for NCT03751280 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sham is the first listed.
NCT03751280 reports 0 study locations.
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.
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