Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25520)(P05846)

Schizophrenia Clinical Trial

— ACTAMESA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00212771
• Other study ID #: P05846
• Secondary ID: 25520
• Status: Completed
• Phase: Phase 3
• Start date: September 2004
• Est. completion date: October 2006

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: October 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• asenapine
Flexible dose, 1-2 tablets sublingual two times per day (1 or 2 tablets in the morning and 1 or 2 tablets in the evening). Each tablet contains either 5 mg asenapine or matching placebo.
• olanzapine
Flexible dose, 1-2 capsules oral once per day (in the morning). Each capsule contains 10 mg olanzapine or matching placebo.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in total PANSS score at endpoint		Screening, Week 76, 100, and once every 24 weeks thereafter until endpoint
Secondary	Changes in PANSS subscale scores and Marder factor scores		Every 24 weeks after baseline
Secondary	Changes in CGI-S		Every 12 weeks after baseline
Secondary	Patient functionality and subjective well-being (as measured by LOF, SF-12 and SWN)		Every 48 weeks after baseline
Secondary	Severity of depressed mood (as measured by the Calgary Depression Scale for Schizophrenia)		Every 24 weeks after baseline
Secondary	Resource utilization (as measured by frequency and length of hospital stay)		During the entire study period
Secondary	Safety and tolerability: EPS (AIMS, BARS, SARS)		Every 24 weeks after baseline
Secondary	Adverse Events		Continuously and up to 7 days after endpoint
Secondary	Pregnancy Test		At endpoint
Secondary	Blood Tests		Every 12 weeks after baseline
Secondary	Weight and vital signs		Every 4 weeks after baseline
Secondary	ECGs		Every 24 weeks after baseline