Schizophrenia
Conditions
Brief summary
This is an extension study of A7501013 (P05771/NCT00145496) to further test the efficacy and safety of Asenapine compared with a marketed agent (olanzapine) in the treatment of patients with persistent negative symptoms of schizophrenia.
Interventions
DRUGasenapine
5-10 mg sublingually twice daily for 26 weeks
DRUGolanzapine
5-20 mg by mouth once daily for 26 weeks
Sponsors
Organon and Co
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Continue to meet all demographic and procedural inclusion criteria of the A7501013 trial to enter into this extension trial. * Have demonstrated an acceptable degree of compliance and completed the A7501013 trial, and would benefit from continued treatment according to the investigator.
Exclusion criteria
* Have an uncontrolled, unstable clinically significant medical condition. * Have been judged to be medically noncompliant in the management of their disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score | Baseline of A7501013 to Day 365 | The NSA Scale is a 16-item clinician-rated instrument for rating the negative symptomatology of schizophrenia. Total score ranges from 16 (best) to 96 (worst), with greater scores indicating greater severity of symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score | Baseline of A7501013 to Day 365 | The QLS is a 21-item clinician-rated scale for rating psychosocial functioning (Interpersonal Relations, Instrumental Role, Intrapsychic Foundations, and Common Objects and Activities). The score ranges from 0 (worst) to 126 (best), with greater values indicating better quality of life. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Asenapine 5-10 mg sublingually twice daily for 26 weeks | 85 |
| Olanzapine 5-20 mg by mouth once daily for 26 weeks | 110 |
| Total | 195 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 7 | 4 |
| Overall Study | Lack of Efficacy | 2 | 2 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Other (Not specified) | 16 | 10 |
| Overall Study | Withdrawal by Subject | 3 | 5 |
Baseline characteristics
| Characteristic | Asenapine | Olanzapine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 84 Participants | 108 Participants | 192 Participants |
| Sex: Female, Male Female | 18 Participants | 27 Participants | 45 Participants |
| Sex: Female, Male Male | 67 Participants | 83 Participants | 150 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 85 | 31 / 110 |
| serious Total, serious adverse events | 4 / 85 | 4 / 110 |
Outcome results
Primary
Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score
The NSA Scale is a 16-item clinician-rated instrument for rating the negative symptomatology of schizophrenia. Total score ranges from 16 (best) to 96 (worst), with greater scores indicating greater severity of symptoms.
Time frame: Baseline of A7501013 to Day 365
Population: Intent-to-treat (ITT) population. In-treatment change from baseline scores by visit and baseline scores from the ITT population are included in the Mixed Model for Repeated Measurements (MMRM) model.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Asenapine | Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score | Baseline | 61.5 Units on a Scale | Standard Error 1.37 |
| Asenapine | Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score | Change from Baseline at Day 365 | -15.8 Units on a Scale | Standard Error 1.48 |
| Olanzapine | Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score | Baseline | 60.3 Units on a Scale | Standard Error 1.2 |
| Olanzapine | Change From Baseline in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale Total Score | Change from Baseline at Day 365 | -11.0 Units on a Scale | Standard Error 1.27 |
Comparison: The null hypothesis was that there was no difference in change from Baseline in NSA Scale total score between asenapine and olanzapine at Day 365.p-value: 0.0148Mixed Model for Repeated Measurements
Secondary
Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score
The QLS is a 21-item clinician-rated scale for rating psychosocial functioning (Interpersonal Relations, Instrumental Role, Intrapsychic Foundations, and Common Objects and Activities). The score ranges from 0 (worst) to 126 (best), with greater values indicating better quality of life.
Time frame: Baseline of A7501013 to Day 365
Population: ITT population. In-treatment change from baseline scores by visit and baseline scores from the ITT population are included in the MMRM model.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Asenapine | Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score | Baseline | 45.3 Units on a Scale | Standard Error 2.27 |
| Asenapine | Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score | Change from Baseline at Day 365 | 12.4 Units on a Scale | Standard Error 2.05 |
| Olanzapine | Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score | Baseline | 42.3 Units on a Scale | Standard Error 1.99 |
| Olanzapine | Change From Baseline in Quality of Life Measured by the Quality of Life Scale (QLS) Total Score | Change from Baseline at Day 365 | 11.7 Units on a Scale | Standard Error 1.73 |
Comparison: The null hypothesis was that there was no difference in change from Baseline in QLS total score between asenapine and olanzapine at Week 52.p-value: 0.81Mixed Model for Repeated Measurements