Schizophrenia
Conditions
Brief summary
This is an extension study 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 25543 trial (NCT 00212836; P05817) to enter into this extension trial. * Have demonstrated an acceptable degree of compliance and completed the 25543 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 |
|---|---|---|
| Long-term Change in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale | Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544) | Decrease from baseline in the NSA scores indicates improvement of efficacy. Range NSA total score is 16 \[best\]-96 \[worst\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life Measured by Quality of Life Scale (QLS) | Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544) | Increase from baseline in the QLS scores indicates improvement of efficacy. Range QLS total score is 0 \[worst\]-126 \[best\]. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Asenapine 5-10 mg twice daily (bid) sublingual (SL) | 134 |
| Olanzapine 5-20 mg daily (QD) orally (PO) | 172 |
| Total | 306 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 10 | 7 |
| Overall Study | Other | 8 | 3 |
| Overall Study | Withdrawal by Subject | 3 | 9 |
Baseline characteristics
| Characteristic | Asenapine | Olanzapine | Total |
|---|---|---|---|
| Age, Continuous | 39.9 years STANDARD_DEVIATION 12.2 | 40.7 years STANDARD_DEVIATION 11.7 | 40.4 years STANDARD_DEVIATION 11.9 |
| Sex: Female, Male Female | 43 Participants | 53 Participants | 96 Participants |
| Sex: Female, Male Male | 91 Participants | 119 Participants | 210 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 19 / 134 | 21 / 172 |
| serious Total, serious adverse events | 9 / 134 | 6 / 172 |
Outcome results
Primary
Long-term Change in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale
Decrease from baseline in the NSA scores indicates improvement of efficacy. Range NSA total score is 16 \[best\]-96 \[worst\].
Time frame: Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544)
Population: Intent-to-treat population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Asenapine | Long-term Change in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale | -16.9 Units on a Scale | Standard Error 0.98 |
| Olanzapine | Long-term Change in Negative Symptoms of Schizophrenia Measured by the Negative Symptom Assessment (NSA) Scale | -15.4 Units on a Scale | Standard Error 0.85 |
Secondary
Change in Quality of Life Measured by Quality of Life Scale (QLS)
Increase from baseline in the QLS scores indicates improvement of efficacy. Range QLS total score is 0 \[worst\]-126 \[best\].
Time frame: Baseline of Protocol 25543 (NCT 00212836) to 365 days (total time for both protocols 25543 & 25544)
Population: Intent-to-treat population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Asenapine | Change in Quality of Life Measured by Quality of Life Scale (QLS) | 18.7 Units on a Scale | Standard Error 1.64 |
| Olanzapine | Change in Quality of Life Measured by Quality of Life Scale (QLS) | 16.4 Units on a Scale | Standard Error 1.4 |