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| ID | Type | Description | Link |
|---|---|---|---|
| 132325 | Registry Identifier | Japic-CTI | |
| MK-8274-042 | Other Identifier | Merck protocol number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asenapine | Experimental | Asenapine 5 mg twice daily (BID) for the first week of treatment, then either 5 mg or 10 mg BID. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asenapine | Drug | 5 mg or 10 mg fast-dissolving sublingual tablets BID for up to 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | Baseline and Week 52 |
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Inclusion Criteria:
Minimum age of 20 years
Participants who meet at least one of the following:
Participants who have a Clinical Global Impressions-Severity (CGI-S) score of at least 4 (moderately ill) at the baseline
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Asenapine | All participants receive asenapine 5 mg twice daily (BID) for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Asenapine | All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants who received at least one dose of study drug and had both a baseline and a Week 52 value of the measure. | Posted | Mean | Standard Deviation | kg | Baseline and Week 52 |
|
Up to 30 days after last dose of study drug (Up to approximately 56 weeks)
Analysis population is participants who received at least one dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Asenapine | All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C522667 | asenapine |
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| 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. |
| 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. | 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. | 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. | Baseline up to Week 52 |
| Lost to Follow-up |
|
| Other reason (not specified) |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body Mass index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Hemoglobin A1c (HbA1c) | Mean | Standard Deviation | percent |
|
| Fasting glucose | For this measure, N=156 | Mean | Standard Deviation | mmol/L |
|
| Insulin | Mean | Standard Deviation | µIU/mL |
|
| Prolactin | Mean | Standard Deviation | µg/L |
|
| Positive and Negative Syndrome Scale (PANSS) total score | The PANSS is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score (30 items) ranged from 30 to 210 with a higher score indicating greater severity of symptoms. | Mean | Standard Deviation | score on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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. | Participants who received at least one dose of study drug and had both a baseline and a Week 52 value of the measure. | Posted | Mean | Standard Deviation | kg/m^2 | Baseline and Week 52 |
|
|
|
| Primary | 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. | Participants who received at least one dose of study drug. | Posted | Number | participants | Up to 30 days after last dose of study drug (Up to approximately 56 weeks) |
|
|
|
| Primary | 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. | Participants who received at least one dose of study drug and had both a baseline and a Week 52 value of the measure. | Posted | Mean | Standard Deviation | percent | Baseline and Week 52 |
|
|
|
| Primary | 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. | Participants who received at least one dose of study drug and had both a baseline and a Week 52 value of the measure. | Posted | Mean | Standard Deviation | mmol/L | Baseline and Week 52 |
|
|
|
| Primary | 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. | Participants who received at least one dose of study drug and had both a baseline and a Week 52 value of the measure. | Posted | Mean | Standard Deviation | µIU/mL | Baseline and Week 52 |
|
|
|
| Primary | 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. | Participants who received at least one dose of study drug and had both a baseline and a Week 52 value of the measure. | Posted | Mean | Standard Deviation | µg/L | Baseline and Week 52 |
|
|
|
| Primary | 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. | Participants who received at least one dose of study drug and had both a baseline and a Week 52 PANSS measurement. | Posted | Mean | Standard Error | score on a scale | Baseline and Week 52 |
|
|
|
| Primary | 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. | Participants who received at least one dose of study drug and had a baseline and at least one post-baseline PANSS measurement. | Posted | Mean | Standard Error | score on a scale | Baseline up to Week 52 |
|
|
|
| 14 |
| 157 |
| 111 |
| 157 |
| Abdominal abscess | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
|
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.1 | Systematic Assessment |
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| Completed suicide | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
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| Schizophrenia | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
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| Postresuscitation encephalopathy | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | MedDRA 17.1 | Systematic Assessment |
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| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Ileus | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Death | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
|
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 17.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Blood prolactin increased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 17.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| Extrapyramidal disorder | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
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| Schizophrenia | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
|
Initial public presentation of the Investigator's results will occur only together with the other sites unless permission is obtained from Sponsor. Sponsor must be able to review all proposed results communications regarding study 45 days prior to submission for publication/presentation. In case of disagreement concerning appropriateness of materials, Investigator and Sponsor must meet to make a good faith effort to discuss/resolve the issues, prior to submission for publication/presentation.
| Title | Measurements |
|---|---|
|
| Dystonia |
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| Extrapyramidal disorder |
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| Parkinsonism |
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| Tremor |
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| Oculogyric crisis |
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| Gait disturbance |
|