43 completed, 2 terminated, 2 unknown, 1 active not recruiting. 33 Phase 3, 8 Phase 4, 3 Phase 2, 2 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 33 | Completed 31, Suspended 1, Unknown 1 |
| Phase 4 | 8 | Completed 6, Active not recruiting 1, Unknown 1 |
| Phase 2 | 3 | Completed 2, Terminated 1 |
| Phase 1 | 2 | Completed 2 |
Follow asenapine: new trials by email Literature Review of asenapine trials Research Report on asenapine
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Τhe Combination of Pharmacotherapy With RECOVERYTRSGR and RECOVERYTRSBDGR. Group A: (Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol,anxiolytics: clonazepam, stedon, tavor antidepressants: seropram),, Group B (Pharmacotherapy and TAU) (Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, antidepressants,, Group C (Pharmacotherapy and Psychotherapy) Clozapine, quietiapine, olanzapine, aripiprazole, zyprasidone, risperidone, asenapine, paliperidone, clopixol, clonazepam, stedon, tavor, lithium, depakine - Treatment Resistant Schizophrenia, Treatment Resistant Bipolar Disorder | Phase 4 | Active not recruiting | Dr. Stavroula Rakitzi | 84 | 2025-06-04 | 2026-05-01 |
| Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies Lithium Carbonate, Lamotrigine, Valproic Acid - Bipolar Disorder | Terminated | University of New Mexico | 1037352 | 2016-09-01 | 2024-03-12 | |
| Family Intervention in Recent Onset Schizophrenia Treatment (FIRST) Caregiver psycho-education and skills training, Caregiver support available at the study site, Paliperidone palmitate - Schizophrenia | Completed | Janssen Scientific Affairs, LLC | 296 | 2015-07-24 | 2019-01-23 | |
| Investigator Initiated Study - Asenapine Early Psychosis Asenapine - Schizophrenia and Disorders With Psychotic Features, Disorders | Phase 4 | Unknown | Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec | 12 | 2013-10-01 | 2014-01-09 |
| Asenapine for Bipolar Depression Asenapine, Placebo - Bipolar Depression | Phase 2 | Terminated | University of Cincinnati | 51 | 2013-09-01 | 2017-07-24 |
| Bio-equivalence Study Between SAPHRIS and Asenapine SAPHRIS, Asenapine - Schizophrenia, Bipolar Disorder | Phase 1 | Completed | Sun Pharmaceutical Industries Limited | 65 | 2013-07-01 | 2021-04-30 |
| An Observational Drug Utilization Study of Asenapine in the United Kingdom (P08308) Asenapine, Aripiprazole, Quetiapine - Bipolar Disorder | Completed | Organon and Co | 42 | 2013-04-01 | 2022-02-04 | |
| A Study of the Efficacy and Safety of Asenapine in Participants With an Acute Exacerbation of Schizophrenia (P05688) Asenapine, Placebo Asenapine, Olanzapine - Schizophrenia | Phase 3 | Completed | Organon and Co | 360 | 2012-12-04 | 2024-06-18 |
| Long-Term Safety Extension Trial of Asenapine in Schizophrenia Participants Who Completed Protocol P05688 (P05689) Asenapine, Placebo Asenapine, Olanzapine - Schizophrenia | Phase 3 | Completed | Forest Laboratories | 105 | 2012-12-01 | 2015-05-27 |
| Clinical Trial to Evaluate the Efficacy of Treatment vs Discontinuation in a First Episode of Non-affective Psychosis Discontinuation antipsychotic treatment, Antipsychotic treatment - Psychosis Nos/Other | Phase 3 | Unknown | Fundación Pública Andaluza Progreso y Salud | 104 | 2012-11-01 | 2014-12-05 |
| Antidepressant Plus Asenapine Versus Antidepressant Plus Placebo for Depression Asenapine 5-20 mg daily, Placebo 1-4 tablets daily - Major Depressive Disorder Without Psychotic Features | Phase 4 | Completed | Duke University | 46 | 2012-10-01 | 2015-10-01 |
| A Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Tolerability of Asenapine With Flexible Dosing From 5mg to 20mg in Adults With Developmental Stuttering Asenapine - Stuttering | Phase 3 | Suspended | University of California, Irvine | 32 | 2012-09-01 | 2014-05-20 |
| An Open Label Pilot Study of Adjunctive Asenapine for the Treatment of Posttraumatic Stress Disorder Adjunctive asenapine - Posttraumatic Stress Disorder | Phase 4 | Completed | Lori Davis, MD | 18 | 2012-06-01 | 2019-06-11 |
| Fixed-dose Safety and Efficacy Study of Asenapine for the Treatment of Acute Manic or Mixed Episode in Bipolar 1 Disorder (P05691) Asenapine, Placebo - Bipolar 1 Disorder | Phase 3 | Completed | Organon and Co | 367 | 2012-04-06 | 2024-06-18 |
| Treating Acutely Agitated Patients With Asenapine Sublingual Tablets Asenapine, Placebo - Agitation | Phase 4 | Completed | Unity Health Toronto | 120 | 2012-04-01 | 2016-05-16 |
| Once-Daily Asenapine for Schizophrenia Asenapine 10 mg daily in the evening, Asenapine 5 mg twice daily - Schizophrenia | Phase 4 | Completed | Duke University | 30 | 2012-04-01 | 2014-05-26 |
| Long-Term Safety Extension Trial of Asenapine in Bipolar 1 Disorder Participants Who Completed Protocol P05691 (P05692) asenapine - Bipolar I Disorder | Phase 3 | Completed | Forest Laboratories | 165 | 2012-04-01 | 2015-05-27 |
| Efficacy and Safety of Asenapine in the Prevention of Recurrence of Mood Episodes in Participants With Bipolar 1 Disorder (P06384) asenapine, placebo - Bipolar 1 Disorder | Phase 3 | Completed | Forest Laboratories | 561 | 2011-12-01 | 2015-12-04 |
| Asenapine in the Treatment of Older Adults With Bipolar Disorder Asenapine - Bipolar Disorder | Phase 4 | Completed | University Hospitals Cleveland Medical Center | 15 | 2011-10-01 | 2014-12-30 |
| Efficacy and Safety of Asenapine Treatment for Pediatric Bipolar Disorder (P06107 Has an Extension [P05898; NCT01349907])(P06107) asenapine, Placebo to match asenapine, Rescue medication - Bipolar Disorder, Pediatric | Phase 3 | Completed | Organon and Co | 404 | 2011-06-16 | 2024-06-20 |
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Schizophrenia (25) · Bipolar Disorder (13) · Psychotic Disorders (7) · Depression (2) · Disorders of Sex Development (2) · Schizophrenia, Disorganized (2) · Schizophrenia, Paranoid (2) · Disease (1) · Obesity (1) · Psychomotor Agitation (1) · Schizophrenia Spectrum and Other Psychotic Disorders (1) · Schizophrenia, Treatment-Resistant (1) · Stress Disorders, Post-Traumatic (1) · Stuttering (1) · Tooth, Impacted (1)
Organon and Co (32) · Forest Laboratories (3) · Duke University (2) · Centre de Recherche de l'Institut Universitaire en Santé Mentale de Québec (1) · Dr. Stavroula Rakitzi (1) · Fundación Pública Andaluza Progreso y Salud (1) · Janssen Scientific Affairs, LLC (1) · Johns Hopkins University (1) · Lori Davis, MD (1) · Sun Pharmaceutical Industries Limited (1) · Unity Health Toronto (1) · University Hospitals Cleveland Medical Center (1) · University of California, Irvine (1) · University of Cincinnati (1) · University of New Mexico (1)
United States (14) · Bulgaria (1) · Canada (1) · Croatia (1) · Greece (1) · India (1) · Philippines (1) · Romania (1) · Russia (1) · Serbia (1) · Spain (1) · Turkey (Türkiye) (1) · Ukraine (1)
John Beyer, MD (2) · Caleb M Adler, MD (1) · Christoph Correll, MD (1) · Christophe G Lambert, PhD (1) · David Frey, MD (1) · David Walling, MD (1) · Dr. Polyxeni Georgila, M. D. (1) · Dr. Stavroula Rakitzi, PhD (1) · Evagelos Coskinas, MD (1) · Gerald Maguire, M.D. (1) · Gilbert R. Weiner, DO (1) · Gloria Reeves, MD (1) · James S. McDonough, MD (1)
PMID 22198451, PMID 22198448, PMID 23290326, PMID 23473546, PMID 24329543, PMID 25367164, PMID 26091193, PMID 26598478, PMID 29105003, PMID 19832806, PMID 20096936, PMID 20205074, PMID 20520283, PMID 20537396, PMID 21367356, PMID 21755540, PMID 22454251, PMID 24606117, PMID 26496015, PMID 27271087, PMID 27461426, PMID 27738377, PMID 27821210, PMID 28901625, PMID 28946761, PMID 29920885, PMID 30986735, PMID 31237566, PMID 31651956, PMID 31744781, PMID 33688834, PMID 35436231, PMID 37232002
2009 (2), 2004 (1), R01MH080270 (1)