Phase 3
N=360
A Study of the Efficacy and Safety of Asenapine in Participants With an Acute Exacerbation of Schizophrenia (P05688)
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01617187 ↗Enrolled (actual)
360
Serious AEs
5.3%
Results posted
Aug 2015
Primary outcome: Primary: Change From Baseline in PANSS Total Score at Day 42 — -17.4; -21.7; -21.6; -16.2 score on a scale — p=0.6043
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Asenapine (Drug); Placebo Asenapine (Drug); Olanzapine (Drug); Placebo Olanzapine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in PANSS Total Score at Day 42 |
-17.4; -21.7; -21.6; -16.2 | 0.6043 |
| SECONDARY Change From Baseline in CGI-S Score at Day 42 |
-0.9; -1.2; -1.1; -1.0 | 0.9083 |
| SECONDARY Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Day 42 |
14.6; 25.2; 26.7; 19.2 | 0.3700 |
| SECONDARY Change From Baseline in Body Weight at Day 42 |
1.3; 1.3; 2.4; 0.3 | 0.0491 sig |
| SECONDARY Change From Baseline in PANSS Total Score at Days 4, 7, 14, 21, 28 and 35 |
-4.0; -4.9; -5.5; -4.8; -7.2; -9.1 | 0.4849 |
| SECONDARY Percentage of Participants Who Are PANSS Responders (≥30% Reduction From Baseline in PANSS Total Score) at Days 4, 7, 14, 21, 28 and 35 |
0.0; 0.0; 0.0; 2.1; 2.1; 5.4 | 0.1736 |
| SECONDARY Change From Baseline in CGI-S Score at Days 4, 7, 14, 21, 28 and 35 |
-0.1; -0.2; -0.2; -0.2; -0.3; -0.3 | 0.4255 |
| SECONDARY Percentage of Participants Who Are Clinical Global Impression Scale-Improvement (CGI-I) Responders at Days 4, 7, 14, 21, 28, 35 and 42 |
34.7; 33.3; 43.2; 37.8; 51.0; 46.8 | 0.6205 |
| SECONDARY Change From Baseline in PANSS Negative Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42 |
-0.7; -0.5; -0.9; -0.8; -1.2; -1.3 | 0.8829 |
| SECONDARY Change From Baseline in PANSS Positive Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42 |
-1.2; -1.6; -2.3; -1.7; -2.3; -2.8 | 0.2160 |
| SECONDARY Change From Baseline in PANSS General Psychopathology Subscale Score at Days 4, 7, 14, 21, 28, 35 and 42 |
-2.2; -2.7; -2.5; -2.4; -3.8; -4.9 | 0.7819 |
| SECONDARY Change From Baseline in PANSS Marder Factor Positive Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42 |
-1.3; -1.8; -2.0; -2.0; -2.5; -2.9 | 0.0584 |
| SECONDARY Change From Baseline in PANSS Marder Factor Negative Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42 |
-1.2; -0.8; -0.8; -0.7; -1.7; -1.9 | 0.2754 |
| SECONDARY Change From Baseline in PANSS Marder Factor Disorganized Thought Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42 |
-0.3; -0.7; -1.1; -0.7; -1.0; -1.4 | 0.2116 |
| SECONDARY Change From Baseline in PANSS Marder Factor Hostility/Excitement Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42 |
-0.4; -0.3; -0.7; -0.5; -0.5; -0.5 | 0.7847 |
| SECONDARY Change From Baseline in PANSS Marder Factor Anxiety/Depression Symptom Score at Days 4, 7, 14, 21, 28, 35 and 42 |
-0.9; -1.2; -1.0; -0.9; -1.5; -2.2 | 0.9851 |
Summary
The purpose of this trial is to assess the effect of asenapine 2.5 and 5 mg sublingually twice daily (BID) compared with placebo in the treatment of schizophrenia (overall symptoms) as measured by the Positive and Negative Syndrome Scale (PANSS). Olanzapine administered 15 mg orally once daily (QD) was used as an active control. The primary hypothesis is that at least one of the asenapine doses is superior to placebo in improving schizophrenia symptoms as measured by the change from Baseline in the PANSS total score at Day 42. The first key secondary hypothesis is that at least one of the asenapine doses is superior to placebo in improving schizophrenia symptoms as measured by the change from Baseline in Clinical Global Impression Scale-Severity (CGI-S) score at Day 42. The second key secondary hypothesis is that at least one of the asenapine doses is superior to placebo in improving schizophrenia symptoms as measured by the rate of PANSS responders (≥30% Reduction From Baseline in PANSS Total Score) at Day 42.
Eligibility Criteria
Inclusion Criteria
- Current diagnosis of schizophrenia of paranoid, disorganized, or undifferentiated subtype
- Minimum PANSS total score of 70 at Screening and Baseline
- Score of at least 4 (moderate) in two or more of the five items in the positive subscale of the PANSS
- Confirmed to be experiencing an acute exacerbation of schizophrenia
- CGI-S scale score of at least 4 (moderately ill) at Baseline
- Has responded positively to an antipsychotic medication other than clozapine (Clozaril®) in a prior episode
Exclusion Criteria
- Body mass index (BMI) 40.0 kg/m^2
- Laboratory and/or clinical evidence of clinically significant hepatic conditions
- Known history of, or undergoing treatment for, narrow angle glaucoma
- Diagnosed with epilepsy or has had any seizure disorder beyond childhood febrile seizures
- Known serological evidence of human immunodeficiency virus (HIV) antibody
- History of neuroleptic malignant syndrome or tardive dyskinesias
- Past or current diagnosis of schizoaffective disorder, schizophrenia of residual subtype, schizophrenia of catatonic subtype, current diagnosis of schizophrenia with course specifiers continuous, single episode in partial remission, or single episode in full remission, or borderline personality disorder
Data sourced from ClinicalTrials.gov (NCT01617187). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.