Clinical trial NCT00156117: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 417
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in total PANSS score at endpoint (6-week double-blind or last assessment after baseline) from baseline
timeFrame: Screen, baseline, Days 4,7,14,21,28,35,42
Secondary outcomes:
measure: Changes in PANSS subscale and Marder factor scores; CGI-S scores
timeFrame: Screen, baseline, Days 4,7,14,21,28,35,42
measure: CGI-I scores
timeFrame: Days 4,7,14,21,28,35,42
measure: Neurocognition and cognitive functioning
timeFrame: Baseline , day 42
measure: Anxiety
timeFrame: Baseline, day 42
measure: Suicidal thinking
timeFrame: Baseline, day 42
measure: Quality of life and patient functionality
timeFrame: Baseline, day 42
measure: Readiness to discharge, at scheduled assessments and endpoint from baseline
timeFrame: Baseline up to day 14
measure: Extrapyramidal symptoms
timeFrame: Baseline, Days 4,7,14,21,28,35,42
measure: Laboratory parameters
timeFrame: Baseline, Days 14,,28,,42
measure: Vital signs
timeFrame: Baseline, Days ,14,21,28,42
measure: Weight
timeFrame: Baseline, Days 14,,28,,42
measure: ECGs
timeFrame: Baseline, Days ,14,,28,,42
measure: Adverse events (including serious adverse events)
timeFrame: Screen, baseline, Days 4,7,14,21,28,35,42 and are are recorded continuously for AEs up to 7 days after endpoint
measure: SAEs up to 30 days after endpoint
timeFrame: Screen, baseline, Days 4,7,14,21,28,35,42 and are are recorded continuously for AEs up to 30 days after endpoint
Other outcomes:
Locations:
Study officials:
References:
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.
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.