Last reviewed · How we verify
NCT00156117
Efficacy and Safety of Asenapine With Placebo and Olanzapine (41021)(P05933)
Phase 3 trial testing asenapine in Schizophrenia in 417 participants. Completed in 30 May 2006.
28 April 2006
Quick facts
| Lead sponsor | Organon and Co |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 417 |
| Start date | 12 May 2005 |
| Primary completion | 28 April 2006 |
| Estimated completion | 30 May 2006 |
Drugs / interventions tested
- asenapine (ASENAPINE) — full drug profile →
- Placebo
- olanzapine (olanzapine) — full drug profile →
Conditions studied
- Schizophrenia — all drugs for Schizophrenia →
Sponsor
Organon and Co — full company profile →
Who can join
18 and older, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Schizophrenia is a brain disease. The primary features of schizophrenia are characterized by Positive symptoms (symptoms that should not be there, inability to think clearly, to distinguish reality from fantasy i.e., hearing voices) and Negative symptoms (a reduction or absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and relate to others). Other symptoms include reduced ability to recall and learn new information, difficulty with problem solving, or maintaining productive employment. The symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other. Asenapine is an investigational drug that may help to correct the imbalance in dopamine and serotonin. This is a 6 week study to test the efficacy and safety of asenapine and a comparator agent (olanzapine) in the treatment of patients with schizophrenia. Patients that complete this trial will have the option of continuing in an additional one year extension trial.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Role of sublingual asenapine in treatment of schizophrenia.
Citrome L. · · 2011 · cited 19× · PMID 21655346 · DOI 10.2147/ndt.s16077 -
Asenapine versus placebo for schizophrenia.
Hay A, Byers A, Sereno M, Basra MK, et al · · 2015 · cited 10× · PMID 26599405 · DOI 10.1002/14651858.cd011458.pub2
Verify or expand the search:
- PubMed search for NCT00156117
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of asenapine
Trials testing the same drug.
- NCT01244815 — Efficacy and Safety of Asenapine Treatment for Pediatric Bipolar Disorder (P06107 Has an Extension [P05898; NCT01349907] · Phase 3 · completed
- NCT01190267 — Flexible Dose, Long-term Safety Study of Asenapine for the Treatment of Schizophrenia in Adolescents (P05897) · Phase 3 · completed
- NCT00212836 — Efficacy and Safety of Asenapine Compared With Olanzapine in Patients With Persistent Negative Symptoms of Schizophrenia · Phase 3 · completed
- NCT00151424 — Efficacy and Safety of Asenapine With Placebo and Olanzapine (41022)(P05947) · Phase 3 · completed
- NCT00212784 — Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (255 · Phase 3 · completed
Other recruiting trials for Schizophrenia
Currently open trials in the same condition.
- NCT07424404 — A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Au · Phase 3 · recruiting
- NCT07467993 — Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia · Phase 2 · recruiting
- NCT07379827 — Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT) · recruiting
- NCT06758414 — CBT-CP for Veterans With SMI · NA · recruiting
- NCT07395206 — Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Dis · NA · recruiting
Other Organon and Co trials
Trials by the same sponsor.
- NCT05761444 — Effectiveness and Safety Study of Early add-on of Ezetimibe With Atorvastatin in Very High-risk Patients · Phase 4 · completed
- NCT05789576 — A Study to Investigate Efficacy and Safety of VTAMA® (Tapinarof) Cream, 1% in Plaque Psoriasis in the Head and Neck Regi · Phase 4 · completed
- NCT05680740 — A Study to Investigate Efficacy and Safety of VTAMA (Tapinarof) Cream, 1% in Intertriginous Plaque Psoriasis · Phase 4 · completed
- NCT05560646 — A Study to Investigate Efficacy and Safety of OG-6219 BID in 3 Dose Levels Compared With Placebo in Participants Aged 18 · Phase 2 · completed
- NCT05264506 — Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive · Phase 3 · terminated
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 NCT00156117 (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 Organon and Co
- Last refreshed: 15 August 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/NCT00156117.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing