A Phase 3 interventional study of Asenapine in Schizophrenia, sponsored by Organon and Co. Completed. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-05-28.
Sponsored by Organon and Co · Phase 3, Interventional, and Treatment
This is a multi-site, open-label fixed-flexible dose long-term study of asenapine in participants with schizophrenia. Participants in this study consist of schizophrenia with residual subtype or receiving high dose/multiple antipsychotic drugs, treatment refractory, or elderly participants with schizophrenia. The treatment period is up to 52 weeks.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 157 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.
Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants who meet at least one of the following:
Exclusion Criteria:
Asenapine 5 mg twice daily (BID) for the first week of treatment, then either 5 mg or 10 mg BID.
Drug: Asenapine
5 mg or 10 mg fast-dissolving sublingual tablets BID for up to 52 weeks
Change From Baseline in Weight at Week 52
For each participant, change from baseline in weight was calculated as the Week 52 value minus the baseline value.
Time frame: Baseline and Week 52
Change From Baseline in BMI at Week 52
For each participant, change from baseline in BMI was calculated as the Week 52 value minus the baseline value.
Time frame: Baseline and Week 52
Number of Participants With Extrapyramidal Symptoms
This measure reports the overall number of participants with any of a group of adverse events that were defined to represent extrapyramidal symptoms. The number of participants with each of the individual adverse events within this definition is also presented, for terms that occurred in at least one participant. For this measure, all adverse event terms within the Medical Dictionary for Regulatory Activities (MedDRA) Standardized MedDRA Query (SMQ) for "extrapyramidal syndrome" were treated as extrapyramidal symptoms.
Time frame: Up to 30 days after last dose of study drug (Up to approximately 56 weeks)
Change From Baseline in HbA1c at Week 52
Blood samples for determination of HbA1c were obtained at baseline and during the study. For each participant, change from baseline in HbA1c at Week 52 was calculated as the Week 52 value minus the baseline value.
Time frame: Baseline and Week 52
Change From Baseline in Fasting Glucose at Week 52
Blood samples for determination of fasting glucose level were obtained at baseline and during the study. For each participant, change from baseline in fasting glucose at Week 52 was calculated as the Week 52 level minus the baseline level.
Time frame: Baseline and Week 52
Change From Baseline in Insulin at Week 52
Blood samples for determination of insulin level were obtained at baseline and during the study. For each participant, change from baseline in insulin at Week 52 was calculated as the Week 52 level minus the baseline level.
Time frame: Baseline and Week 52
Change From Baseline in Prolactin at Week 52
Blood samples for determination of prolactin level were obtained at baseline and during the study. For each participant, change from baseline in prolactin at Week 52 was calculated as the Week 52 level minus the baseline level.
Time frame: Baseline and Week 52
Change From Baseline in PANSS Total Score at Week 52
The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Week 52 (calculated for a participant as Week 52 value minus baseline value); improvement in symptoms is represented by negative values.
Time frame: Baseline and Week 52
Change From Baseline in PANSS Total Score at Final Assessment
The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at the final assessment for a participant (calculated for a participant as final assessment value minus baseline value); improvement in symptoms is represented by negative values.
Time frame: Baseline up to Week 52
| Milestone | Asenapine |
|---|---|
| Started | 157 |
| Completed | 79 |
| Not completed | 78 |
| Withdrew: Adverse event | 37 |
| Withdrew: Withdrawal by subject | 31 |
| Withdrew: Lack of efficacy | 7 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Other reason (not specified) | 1 |
For each participant, change from baseline in weight was calculated as the Week 52 value minus the baseline value.
| kg | Asenapine |
|---|---|
| Change From Baseline in Weight at Week 52 | 0.25 ± 5.23 |
For each participant, change from baseline in BMI was calculated as the Week 52 value minus the baseline value.
| kg/m^2 | Asenapine |
|---|---|
| Change From Baseline in BMI at Week 52 | 0.07 ± 1.93 |
This measure reports the overall number of participants with any of a group of adverse events that were defined to represent extrapyramidal symptoms. The number of participants with each of the individual adverse events within this definition is also presented, for terms that occurred in at least one participant. For this measure, all adverse event terms within the Medical Dictionary for Regulatory Activities (MedDRA) Standardized MedDRA Query (SMQ) for "extrapyramidal syndrome" were treated as extrapyramidal symptoms.
| participants | Asenapine |
|---|---|
| Any extrapyramidal symptom | 24 |
| Restlessness | 3 |
| Akathisia | 3 |
| Dystonia | 2 |
| Extrapyramidal disorder | 10 |
| Parkinsonism | 1 |
| Tremor | 5 |
| Oculogyric crisis | 2 |
| Gait disturbance | 1 |
Blood samples for determination of HbA1c were obtained at baseline and during the study. For each participant, change from baseline in HbA1c at Week 52 was calculated as the Week 52 value minus the baseline value.
| percent | Asenapine |
|---|---|
| Change From Baseline in HbA1c at Week 52 | 0.00 ± 0.26 |
Blood samples for determination of fasting glucose level were obtained at baseline and during the study. For each participant, change from baseline in fasting glucose at Week 52 was calculated as the Week 52 level minus the baseline level.
| mmol/L | Asenapine |
|---|---|
| Change From Baseline in Fasting Glucose at Week 52 | 0.11 ± 0.63 |
Blood samples for determination of insulin level were obtained at baseline and during the study. For each participant, change from baseline in insulin at Week 52 was calculated as the Week 52 level minus the baseline level.
| µIU/mL | Asenapine |
|---|---|
| Change From Baseline in Insulin at Week 52 | 2.31 ± 11.93 |
Blood samples for determination of prolactin level were obtained at baseline and during the study. For each participant, change from baseline in prolactin at Week 52 was calculated as the Week 52 level minus the baseline level.
| µg/L | Asenapine |
|---|---|
| Change From Baseline in Prolactin at Week 52 | 0.66 ± 24.20 |
The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Week 52 (calculated for a participant as Week 52 value minus baseline value); improvement in symptoms is represented by negative values.
| score on a scale | Asenapine |
|---|---|
| Change From Baseline in PANSS Total Score at Week 52 | -11.08 ± 1.36 |
The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at the final assessment for a participant (calculated for a participant as final assessment value minus baseline value); improvement in symptoms is represented by negative values.
| score on a scale | Asenapine |
|---|---|
| Change From Baseline in PANSS Total Score at Final Assessment | -5.48 ± 1.08 |
Collected over Up to 30 days after last dose of study drug (Up to approximately 56 weeks). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Asenapine | — | 14/157 (8.9%) | 111/157 (70.7%) |
| Event | Asenapine |
|---|---|
| SchizophreniaPsychiatric disorders | 4/157 |
| PneumoniaInfections and infestations | 2/157 |
| Pneumonia aspirationRespiratory, thoracic and mediastinal disorders | 2/157 |
| Abdominal abscessInfections and infestations | 1/157 |
| Bladder neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/157 |
| Completed suicidePsychiatric disorders | 1/157 |
| Postresuscitation encephalopathyNervous system disorders | 1/157 |
| Cardio-respiratory arrestCardiac disorders | 1/157 |
| AsphyxiaRespiratory, thoracic and mediastinal disorders | 1/157 |
| ChokingRespiratory, thoracic and mediastinal disorders | 1/157 |
| Event | Asenapine |
|---|---|
| NasopharyngitisInfections and infestations | 33/157 |
| Weight increasedInvestigations | 20/157 |
| SomnolenceNervous system disorders | 20/157 |
| Hypoaesthesia oralGastrointestinal disorders | 17/157 |
| SchizophreniaPsychiatric disorders | 17/157 |
| PyrexiaGeneral disorders | 14/157 |
| Weight decreasedInvestigations | 12/157 |
| Aspartate aminotransferase increasedInvestigations | 11/157 |
| Back painMusculoskeletal and connective tissue disorders | 11/157 |
| ConstipationGastrointestinal disorders | 10/157 |
| Age, Continuous(years) | Asenapine |
|---|---|
| Mean | 56.37 ± 14.17 |
| Sex: Female, Male(Participants) | Asenapine |
|---|---|
| Female | 76 |
| Male | 81 |
| Weight(kg) | Asenapine |
|---|---|
| Mean | 59.45 ± 13.76 |
| Body Mass index (BMI)(kg/m^2) | Asenapine |
|---|---|
| Mean | 23.04 ± 4.37 |
| Hemoglobin A1c (HbA1c)(percent) | Asenapine |
|---|---|
| Mean | 5.28 ± 0.47 |
| Fasting glucose(mmol/L) | Asenapine |
|---|---|
| Mean | 5.14 ± 0.74 |
| Insulin(µIU/mL) | Asenapine |
|---|---|
| Mean | 6.35 ± 4.73 |
| Prolactin(µg/L) | Asenapine |
|---|---|
| Mean | 43.92 ± 41.66 |
1 further baseline measures are reported on the registry.
No study locations are listed for this record.
Plan to share: No
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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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