Clinical trial NCT00212771: Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25520)(P05846)
Official title: Long-Term Efficacy and Safety Evaluation of Asenapine (10-20 mg/Day) in With Schizophrenia or Schizoaffective Disorder, in a Multicenter Trial Using (10-20 mg/Day) as a Control
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: 440
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 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 maintaining productive employment.

Asenapine is an investigational drug that may help to correct the above schizophrenia by altering the inbalance of brain hormones such as dopamine serotonin. This is a long-term extension trial to further test the efficacy and safety asenapine and a comparator agent (olanzapine) in the treatment of patients with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Subject with schizophrenia or schizoaffective disorder. Must have completed 12 months treatment under protocol 25517. Subject must sign a written informed consent.

Exclusion Criteria:

* Have an uncontrolled, unstable, clinically significant medical condition.

Primary outcomes:
measure: Change in total PANSS score at endpoint
timeFrame: Screening, Week 76, 100, and once every 24 weeks thereafter until endpoint
Secondary outcomes:
measure: Changes in PANSS subscale scores and Marder factor scores
timeFrame: Every 24 weeks after baseline
measure: Changes in CGI-S
timeFrame: Every 12 weeks after baseline
measure: Patient functionality and subjective well-being (as measured by LOF, SF-12 and SWN)
timeFrame: Every 48 weeks after baseline
measure: Severity of depressed mood (as measured by the Calgary Depression Scale for Schizophrenia)
timeFrame: Every 24 weeks after baseline
measure: Resource utilization (as measured by frequency and length of hospital stay)
timeFrame: During the entire study period
measure: Safety and tolerability: EPS (AIMS, BARS, SARS)
timeFrame: Every 24 weeks after baseline
measure: Adverse Events
timeFrame: Continuously and up to 7 days after endpoint
measure: Pregnancy Test
timeFrame: At endpoint
measure: Blood Tests
timeFrame: Every 12 weeks after baseline
measure: Weight and vital signs
timeFrame: Every 4 weeks after baseline
measure: ECGs
timeFrame: Every 24 weeks after baseline
Other outcomes:
Locations:
Study officials:
References:
citation: Schoemaker J, Stet L, Vrijland P, Naber D, Panagides J, Emsley R. Long-term efficacy and safety of asenapine or olanzapine in patients with schizophrenia or schizoaffective disorder: an extension study. Pharmacopsychiatry. 2012 Jul;45(5):196-203. doi: 10.1055/s-0031-1301310. Epub 2012 Mar 27.