Back to resultsLong-term Study of Asenapine in Participants With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (P06238)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Asenapine
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Minimum age of 20 years
Participants who meet at least one of the following:
- current diagnosis of schizophrenia of residual subtype
- received treatment with 3 or more antipsychotic drugs
- treatment-refractory participants with schizophrenia
- 65 years old and over with positive schizophrenia symptoms with score of 3 (mild) or more in 1 or more items in the positive subscale of the Positive and Negative Syndrome Scale (PANSS) at the baseline
- Participants who have a Clinical Global Impressions-Severity (CGI-S) score of at least 4 (moderately ill) at the baseline
Exclusion Criteria:
- Uncontrolled, unstable clinically significant medical condition
- Clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram (ECG) findings at Screening
- Positive pregnancy test at Screening, or the intention to become pregnant during the course of the study
- Seizure disorder beyond childhood (12 years old or younger)
- History of neuroleptic malignant syndrome
- Allergy or sensitivity to drugs such as psychotropics and antipsychotics
- Known history of or currently treated for narrow angle glaucoma
- Parkinson's disease
- Diagnosis of schizoaffective disorder; schizophreniform disorder
- Concurrent psychiatric disorder other than schizophrenia coded on Axis I; a primary diagnosis other than schizophrenia
- Diagnosis of borderline personality disorder
- Diagnosis of mental retardation or organic brain disorder
- Current (past 6 months) substance abuse or dependence according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria (excluding nicotine)
- Positive drug/alcohol tests at the Screening visit
- Imminent risk of self-harm or harm to others, in the Investigator's opinion
- Substance induced psychotic disorder or a behavioral disturbance thought to be due to substance abuse
- Currently under involuntary inpatient confinement
- Use of a non-approved drug in Japan within 12 weeks prior to informed consent
- Previously treated in an asenapine study
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Asenapine
Arm Description
Asenapine 5 mg twice daily (BID) for the first week of treatment, then either 5 mg or 10 mg BID.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01244828
Brief Title
Long-term Study of Asenapine in Participants With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (P06238)
Official Title
Long-term Study of Asenapine in Subjects With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (Protocol P06238)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 5, 2011 (Actual)
Primary Completion Date
August 21, 2014 (Actual)
Study Completion Date
August 21, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
157 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Asenapine
Arm Type
Experimental
Arm Description
Asenapine 5 mg twice daily (BID) for the first week of treatment, then either 5 mg or 10 mg BID.
Intervention Type
Drug
Intervention Name(s)
Asenapine
Intervention Description
5 mg or 10 mg fast-dissolving sublingual tablets BID for up to 52 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Weight at Week 52
Description
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
Title
Change From Baseline in BMI at Week 52
Description
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
Title
Number of Participants With Extrapyramidal Symptoms
Description
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)
Title
Change From Baseline in HbA1c at Week 52
Description
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
Title
Change From Baseline in Fasting Glucose at Week 52
Description
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
Title
Change From Baseline in Insulin at Week 52
Description
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
Title
Change From Baseline in Prolactin at Week 52
Description
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
Title
Change From Baseline in PANSS Total Score at Week 52
Description
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
Title
Change From Baseline in PANSS Total Score at Final Assessment
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Minimum age of 20 years
Participants who meet at least one of the following:
current diagnosis of schizophrenia of residual subtype
received treatment with 3 or more antipsychotic drugs
treatment-refractory participants with schizophrenia
65 years old and over with positive schizophrenia symptoms with score of 3 (mild) or more in 1 or more items in the positive subscale of the Positive and Negative Syndrome Scale (PANSS) at the baseline
Participants who have a Clinical Global Impressions-Severity (CGI-S) score of at least 4 (moderately ill) at the baseline
Exclusion Criteria:
Uncontrolled, unstable clinically significant medical condition
Clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram (ECG) findings at Screening
Positive pregnancy test at Screening, or the intention to become pregnant during the course of the study
Seizure disorder beyond childhood (12 years old or younger)
History of neuroleptic malignant syndrome
Allergy or sensitivity to drugs such as psychotropics and antipsychotics
Known history of or currently treated for narrow angle glaucoma
Parkinson's disease
Diagnosis of schizoaffective disorder; schizophreniform disorder
Concurrent psychiatric disorder other than schizophrenia coded on Axis I; a primary diagnosis other than schizophrenia
Diagnosis of borderline personality disorder
Diagnosis of mental retardation or organic brain disorder
Current (past 6 months) substance abuse or dependence according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria (excluding nicotine)
Positive drug/alcohol tests at the Screening visit
Imminent risk of self-harm or harm to others, in the Investigator's opinion
Substance induced psychotic disorder or a behavioral disturbance thought to be due to substance abuse
Currently under involuntary inpatient confinement
Use of a non-approved drug in Japan within 12 weeks prior to informed consent
Previously treated in an asenapine study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Learn more about this trial
Long-term Study of Asenapine in Participants With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (P06238)
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