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

Sponsor

Organon and Co (Industry)

Overall Status

Completed

CT.gov ID

NCT00212771

Collaborator

(none)

440

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Schizoaffective Disorder	Drug: asenapine Drug: olanzapine	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

440 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Sep 1, 2004

Actual Primary Completion Date :

Sep 1, 2006

Actual Study Completion Date :

Oct 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	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. Other Names: Org 5222 SCH 900274
Active Comparator: Arm 2	Drug: olanzapine Flexible dose, 1-2 capsules oral once per day (in the morning). Each capsule contains 10 mg olanzapine or matching placebo. Other Names: Zyprexa

Arm

Intervention/Treatment

Experimental: Arm 1

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.

Other Names:

Org 5222

SCH 900274

Active Comparator: Arm 2

Drug: olanzapine

Flexible dose, 1-2 capsules oral once per day (in the morning). Each capsule contains 10 mg olanzapine or matching placebo.

Other Names:

Zyprexa

Outcome Measures

Primary Outcome Measures

Change in total PANSS score at endpoint [Screening, Week 76, 100, and once every 24 weeks thereafter until endpoint]

Secondary Outcome Measures

Changes in PANSS subscale scores and Marder factor scores [Every 24 weeks after baseline]
Changes in CGI-S [Every 12 weeks after baseline]
Patient functionality and subjective well-being (as measured by LOF, SF-12 and SWN) [Every 48 weeks after baseline]
Severity of depressed mood (as measured by the Calgary Depression Scale for Schizophrenia) [Every 24 weeks after baseline]
Resource utilization (as measured by frequency and length of hospital stay) [During the entire study period]
Safety and tolerability: EPS (AIMS, BARS, SARS) [Every 24 weeks after baseline]
Adverse Events [Continuously and up to 7 days after endpoint]
Pregnancy Test [At endpoint]
Blood Tests [Every 12 weeks after baseline]
Weight and vital signs [Every 4 weeks after baseline]
ECGs [Every 24 weeks after baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Organon and Co

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Organon and Co

ClinicalTrials.gov Identifier:

NCT00212771

Other Study ID Numbers:

P05846
25520

First Posted:

Sep 21, 2005

Last Update Posted:

Feb 16, 2022

Last Verified:

Feb 1, 2022

Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 16, 2022