Clinical trial NCT00212784: Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)
Official title: A Phase III, Double-Blind, Randomized, Active-Controlled, Two-Armed, Multicenter, Efficacy and Safety Assessment (ACTAMESA) of Org 5222 and Olanzapine in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 1225
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: The primary features of schizophrenia and schizoaffective disorder are characterized by positive (inability to think clearly and distinguish reality from fantasy) and negative symptoms (reduction or absence of normal behavior or emotions). Other symptoms include reduced ability to recall and learn information, difficulty in problem solving or maintaining productive employment. Asenapine is an investigational drug that may help to correct the above characteristics of schizophrenia by altering the inbalance of brain hormones such as dopamine and serotonin. This is a 12-month trial that will test the efficacy and safety of asenapine using an active comparator (olanzapine) in the treatment of patients with schizophrenia. Patients who complete the 12-month trial will have the option of continuing on drug until the treatment code for the 12-month trial is unblinded.


Eligibility criteria: Inclusion Criteria:

* Subject with schizophrenia or schizoaffective disorder. Subject must sign a written informed consent.

Exclusion Criteria:

* Have an uncontrolled, unstable, clinically significant medical condition. Have any other psychiatric disorder other than schizophrenia as a primary diagnosis including depression.

Primary outcomes:
measure: Change in total PANSS score at endpoint (52-week double-blind or last assessment after baseline) from baseline
timeFrame: Screening, Baseline, Week 2, 4, 6, 8, 12, 20, 28, 36, 44, 52 (endpoint)
Secondary outcomes:
measure: Changes in PANSS subscale scores and Marder factor scores
timeFrame: At weeks 2, 4, 6, 8, 12, 20, 28, 36, 44 and endpoint
measure: Changes in CGI-S
timeFrame: At each assessment time point from baseline
measure: Patient functionality and subjective well-being (as measured by LOF, SF-12 and SWN)
timeFrame: At weeks 8, 20, 28, 36, 44 and endpoint
measure: Severity of depressed mood (as measured by the Calgary Depression Scale for Schizophrenia)
timeFrame: At weeks 6, 28 and endpoint
measure: Resource utilization (as measured by frequency and length of hospital stay)
timeFrame: During the study period
measure: Satisfaction with treatment in comparison with previous treatment as assessed by the investigator and patient)
timeFrame: At endpoint
measure: Population kinetics
timeFrame: Plasma samples at weeks 2 and 6 in comparison with baseline
measure: Pharmacogenetics (as part of a global effort to investigate possible associations between genetic polymorphisms in relation to response to asenapine and related drugs and in relation to characteristics of schizophrenia and related conditions)
timeFrame: During the study period
measure: Safety and tolerability: EPS (AIMS, BARS, SARS)
timeFrame: At weeks 1, 3, 6, 16, 24, 32, 40 and endpoint
measure: Adverse Events
timeFrame: continuously and up to 7 days after endpoint
measure: Pregnancy Test
timeFrame: At endpoint
measure: Blood Test
timeFrame: At weeks 1, 3, 6, 16, 24, 32, 40 and endpoint
measure: Weight and vital signs
timeFrame: at all assessment time points from baseline
measure: ECGs
timeFrame: Weeks 3, 6, 24, and endpoint
Other outcomes:
Locations:
Study officials:
References:
citation: Schoemaker J, Naber D, Vrijland P, Panagides J, Emsley R. Long-term assessment of Asenapine vs. Olanzapine in patients with schizophrenia or schizoaffective disorder. Pharmacopsychiatry. 2010 Jun;43(4):138-46. doi: 10.1055/s-0030-1248313. Epub 2010 Mar 4.