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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00212771
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : December 23, 2014
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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 Type : Interventional  (Clinical Trial)
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 : September 2004
Primary Completion Date : September 2006
Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

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 Name: Zyprexa

Primary Outcome Measures :
  1. Change in total PANSS score at endpoint [ Time Frame: Screening, Week 76, 100, and once every 24 weeks thereafter until endpoint ]

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00212771     History of Changes
Other Study ID Numbers: P05846
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents