Efficacy and Safety of Asenapine With Placebo and Olanzapine (41021)(P05933)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
asenapine
Placebo
olanzapine
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria: Currently suffering from an acute exacerbation of schizophrenia. Caregiver required. Exclusion Criteria: Have an uncontrolled, unstable medical condition. Have any other psychiatric disorder other than schizophrenia as a primary diagnosis.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
asenapine 5 mg BID and 10 mg BID
Placebo against olanzapine and asenapine
olanzapine 15 mgQD
Outcomes
Primary Outcome Measures
Change in total PANSS score at endpoint (6-week double-blind or last assessment after baseline) from baseline
Secondary Outcome Measures
Changes in PANSS subscale and Marder factor scores; CGI-S scores
CGI-I scores
Neurocognition and cognitive functioning
Anxiety
Suicidal thinking
Quality of life and patient functionality
Readiness to discharge, at scheduled assessments and endpoint from baseline
Extrapyramidal symptoms
Laboratory parameters
Vital signs
Weight
ECGs
Adverse events (including serious adverse events)
SAEs up to 30 days after endpoint
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00156117
Brief Title
Efficacy and Safety of Asenapine With Placebo and Olanzapine (41021)(P05933)
Official Title
A Multicenter, Randomized, Double-Blind, Fixed-Dose, 6-Week Trial of the Efficacy and Safety of Asenapine Compared With Placebo Using Olanzapine Positive Control in Subjects With an Acute Exacerbation of Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 12, 2005 (Actual)
Primary Completion Date
April 28, 2006 (Actual)
Study Completion Date
May 30, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Schizophrenia is a brain disease. The primary features of schizophrenia are characterized by Positive symptoms (symptoms that should not be there, inability to think clearly, to distinguish reality from fantasy i.e., hearing voices) and Negative symptoms (a reduction or absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and relate to others). Other symptoms include reduced ability to recall and learn new information, difficulty with problem solving, or maintaining productive employment. The symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other.
Asenapine is an investigational drug that may help to correct the imbalance in dopamine and serotonin. This is a 6 week study to test the efficacy and safety of asenapine and a comparator agent (olanzapine) in the treatment of patients with schizophrenia. Patients that complete this trial will have the option of continuing in an additional one year extension trial.
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
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
417 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
asenapine 5 mg BID and 10 mg BID
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo against olanzapine and asenapine
Arm Title
3
Arm Type
Active Comparator
Arm Description
olanzapine 15 mgQD
Intervention Type
Drug
Intervention Name(s)
asenapine
Intervention Description
5 mg BID or 10mg BID
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
olanzapine
Intervention Description
olanzapine 15 mg QD
Primary Outcome Measure Information:
Title
Change in total PANSS score at endpoint (6-week double-blind or last assessment after baseline) from baseline
Time Frame
Screen, baseline, Days 4,7,14,21,28,35,42
Secondary Outcome Measure Information:
Title
Changes in PANSS subscale and Marder factor scores; CGI-S scores
Time Frame
Screen, baseline, Days 4,7,14,21,28,35,42
Title
CGI-I scores
Time Frame
Days 4,7,14,21,28,35,42
Title
Neurocognition and cognitive functioning
Time Frame
Baseline , day 42
Title
Anxiety
Time Frame
Baseline, day 42
Title
Suicidal thinking
Time Frame
Baseline, day 42
Title
Quality of life and patient functionality
Time Frame
Baseline, day 42
Title
Readiness to discharge, at scheduled assessments and endpoint from baseline
Time Frame
Baseline up to day 14
Title
Extrapyramidal symptoms
Time Frame
Baseline, Days 4,7,14,21,28,35,42
Title
Laboratory parameters
Time Frame
Baseline, Days 14,,28,,42
Title
Vital signs
Time Frame
Baseline, Days ,14,21,28,42
Title
Weight
Time Frame
Baseline, Days 14,,28,,42
Title
ECGs
Time Frame
Baseline, Days ,14,,28,,42
Title
Adverse events (including serious adverse events)
Time Frame
Screen, baseline, Days 4,7,14,21,28,35,42 and are are recorded continuously for AEs up to 7 days after endpoint
Title
SAEs up to 30 days after endpoint
Time Frame
Screen, baseline, Days 4,7,14,21,28,35,42 and are are recorded continuously for AEs up to 30 days after endpoint
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Currently suffering from an acute exacerbation of schizophrenia. Caregiver required.
Exclusion Criteria:
Have an uncontrolled, unstable medical condition. Have any other psychiatric disorder other than schizophrenia as a primary diagnosis.
12. IPD Sharing Statement
Citations:
PubMed Identifier
23290326
Citation
Szegedi A, Verweij P, van Duijnhoven W, Mackle M, Cazorla P, Fennema H. Meta-analyses of the efficacy of asenapine for acute schizophrenia: comparisons with placebo and other antipsychotics. J Clin Psychiatry. 2012 Dec;73(12):1533-40. doi: 10.4088/JCP.11r07596.
Results Reference
result
PubMed Identifier
25367164
Citation
Castle DJ, Slott Jensen JK. Management of depressive symptoms in schizophrenia. Clin Schizophr Relat Psychoses. 2015 Apr;9(1):13-20. doi: 10.3371/CSRP.CAJE.103114.
Results Reference
derived
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
Efficacy and Safety of Asenapine With Placebo and Olanzapine (41021)(P05933)
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