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NCT01527305: PREVAIL
A Study to Evaluate the Effectiveness and Safety of Paliperidone Palmitate in Subjects With Acute Schizophrenia
Phase 4 trial testing Paliperidone palmitate in Schizophrenia in 212 participants. Completed in 31 December 2013.
31 December 2013
Quick facts
| Lead sponsor | Janssen Research & Development, LLC |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 212 |
| Start date | 22 June 2012 |
| Primary completion | 31 December 2013 |
| Estimated completion | 31 December 2013 |
| Sites | 21 locations across China, Taiwan, Malaysia, South Korea |
Drugs / interventions tested
- Paliperidone palmitate (PALIPERIDONE PALMITATE) — full drug profile →
Conditions studied
- Schizophrenia — all drugs for Schizophrenia →
Sponsor
Janssen Research & Development, LLC — full company profile →
Who can join
Adults 18 to 65, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate the effectiveness and safety of paliperidone palmitate in schizophrenic inpatients who have experienced recent exacerbation of acute schizophrenia (that is within past 4 weeks).
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Efficacy and safety of once-monthly injection of paliperidone palmitate in hospitalized Asian patients with acute exacerbated schizophrenia: an open-label, prospective, noncomparative study.
Li H, Turkoz I, Zhang F. · · 2016 · cited 21× · PMID 26730193 · DOI 10.2147/ndt.s83651 -
Once-monthly injection of paliperidone palmitate in patients with recently diagnosed and chronic schizophrenia: a post-hoc comparison of efficacy and safety.
Si T, Zhuo J, Turkoz I, Mathews M, et al · · 2017 · cited 9× · PMID 29141463 · DOI 10.1080/14656566.2017.1401608 -
Paliperidone Palmitate Improves and Maintains Functioning in Asia-Pacific Patients with Schizophrenia.
Zhang H, Turkoz I, Zhuo J, Mathews M, et al · · 2017 · cited 9× · PMID 29101715 · DOI 10.1007/s12325-017-0638-0 -
Characteristics of patients with schizophrenia switching from oral antipsychotics to once-monthly paliperidone palmitate (PP1M): a systematic review.
Li Q, Li X, Ye C, Jia M, et al · · 2024 · cited 2× · PMID 38243208 · DOI 10.1186/s12888-024-05508-6 -
Efficacy and Safety of Once-Monthly Paliperidone Palmitate Long-Acting Injections in Chinese Patients with Early-, Mid-, and Late-Phase Schizophrenia: A Post-Hoc Analysis of Three Phase 4 Studies.
Li Q, Li Y, Yang Y, Zhuo J, et al · · 2025 · cited 1× · PMID 40517352 · DOI 10.1007/s40263-025-01194-4
Verify or expand the search:
- PubMed search for NCT01527305
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Paliperidone palmitate
Trials testing the same drug.
- NCT02600741 — Family Intervention in Recent Onset Schizophrenia Treatment (FIRST) · completed
- NCT01051531 — A Safety, Tolerability, and Treatment Response Study of Paliperidone Palmitate Administered to Patients With Schizophren · Phase 3 · completed
Other recruiting trials for Schizophrenia
Currently open trials in the same condition.
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- NCT07379827 — Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT) · recruiting
- NCT06758414 — CBT-CP for Veterans With SMI · NA · recruiting
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Other Janssen Research & Development, LLC trials
Trials by the same sponsor.
- NCT07518186 — A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma · Phase 3 · not yet recruiting
- NCT07309445 — A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC · recruiting
- NCT07499232 — A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease · Phase 3 · not yet recruiting
- NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · Phase 3 · recruiting
- NCT07227025 — A Study of Amivantamab and Olomorasib Combination Therapy in Participants With Metastatic Non-Small Cell Lung Cancer · Phase 1, PHASE2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01527305 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Janssen Research & Development, LLC
- Last refreshed: 28 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01527305.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing