Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)

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: NCT00212784
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : August 22, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: asenapine Drug: olanzapine Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 4, 2003
Primary Completion Date : March 15, 2006
Study Completion Date : March 15, 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
Oral capsules (5 mg or placebo); 1 to 2 tablets twice daily

Primary Outcome Measures :
  1. Change in total PANSS score at endpoint (52-week double-blind or last assessment after baseline) from baseline [ Time Frame: Screening, Baseline, Week 2, 4, 6, 8, 12, 20, 28, 36, 44, 52 (endpoint) ]

Secondary Outcome Measures :
  1. Changes in PANSS subscale scores and Marder factor scores [ Time Frame: At weeks 2, 4, 6, 8, 12, 20, 28, 36, 44 and endpoint ]
  2. Changes in CGI-S [ Time Frame: At each assessment time point from baseline ]
  3. Patient functionality and subjective well-being (as measured by LOF, SF-12 and SWN) [ Time Frame: At weeks 8, 20, 28, 36, 44 and endpoint ]
  4. Severity of depressed mood (as measured by the Calgary Depression Scale for Schizophrenia) [ Time Frame: At weeks 6, 28 and endpoint ]
  5. Resource utilization (as measured by frequency and length of hospital stay) [ Time Frame: During the study period ]
  6. Satisfaction with treatment in comparison with previous treatment as assessed by the investigator and patient) [ Time Frame: At endpoint ]
  7. Population kinetics [ Time Frame: Plasma samples at weeks 2 and 6 in comparison with baseline ]
  8. 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) [ Time Frame: During the study period ]
  9. Safety and tolerability: EPS (AIMS, BARS, SARS) [ Time Frame: At weeks 1, 3, 6, 16, 24, 32, 40 and endpoint ]
  10. Adverse Events [ Time Frame: continuously and up to 7 days after endpoint ]
  11. Pregnancy Test [ Time Frame: At endpoint ]
  12. Blood Test [ Time Frame: At weeks 1, 3, 6, 16, 24, 32, 40 and endpoint ]
  13. Weight and vital signs [ Time Frame: at all assessment time points from baseline ]
  14. ECGs [ Time Frame: Weeks 3, 6, 24, and endpoint ]

Information from the National Library of Medicine

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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. 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.

Study Data/Documents: CSR Synopsis  This link exits the site

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00212784     History of Changes
Other Study ID Numbers: P05935
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017

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