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Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(COMPLETED)
This study has been completed.
Sponsored by: Organon
Information provided by: Organon
ClinicalTrials.gov Identifier: NCT00212784
  Purpose

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 Intervention Phase
Schizophrenia
Schizoaffective Disorder
 Drug: asenapine
Drug: olanzapine
 Phase III

MedlinePlus related topics: Schizophrenia
Drug Information available for: Olanzapine Org 5222
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Organon:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in PANSS subscale scores and Marder factor scores [ Time Frame: At weeks 2, 4, 6, 8, 12, 20, 28, 36, 44 and endpoint ] [ Designated as safety issue: No ]
  • Changes in CGI-S [ Time Frame: At each assessment time point from baseline ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Severity of depressed mood (as measured by the Calgary Depression Scale for Schizophrenia) [ Time Frame: At weeks 6, 28 and endpoint ] [ Designated as safety issue: No ]
  • Resource utilization (as measured by frequency and length of hospital stay) [ Time Frame: During the study period ] [ Designated as safety issue: No ]
  • Satisfaction with treatment in comparison with previous treatment as assessed by the investigator and patient) [ Time Frame: At endpoint ] [ Designated as safety issue: No ]
  • Population kinetics [ Time Frame: Plasma samples at weeks 2 and 6 in comparison with baseline ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Safety and tolerability: EPS (AIMS, BARS, SARS) [ Time Frame: At weeks 1, 3, 6, 16, 24, 32, 40 and endpoint ] [ Designated as safety issue: Yes ]
  • Adverse Events [ Time Frame: continuously and up to 7 days after endpoint ] [ Designated as safety issue: Yes ]
  • Pregnancy Test [ Time Frame: At endpoint ] [ Designated as safety issue: No ]
  • Blood Test [ Time Frame: At weeks 1, 3, 6, 16, 24, 32, 40 and endpoint ] [ Designated as safety issue: No ]
  • Weight and vital signs [ Time Frame: at all assessment time points from baseline ] [ Designated as safety issue: No ]
  • ECGs [ Time Frame: Weeks 3, 6, 24, and endpoint ] [ Designated as safety issue: No ]

Enrollment: 1225
Study Start Date: September 2003
Study Completion Date: March 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1: Experimental 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.
Arm 2: Active Comparator Drug: olanzapine
Oral capsules (5 mg or placebo); 1 to 2 tablets twice daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers: 25517, ACTAMESA
Study First Received: September 13, 2005
Last Updated: August 7, 2008
ClinicalTrials.gov Identifier: NCT00212784  
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration;   Belgium: Directorate general for the protection of Public health: Medicines;   Czech Republic: State Institute for Drug Control;   France: Afssaps - French Health Products Safety Agency;   Germany: Federal Institute for Drugs and Medical Devices;   Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products;   Russia: Ministry of Health and Social Development of the Russian Federation;   South Africa: Medicines Control Council;   United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:
Schizophrenia
Mental Disorders
Olanzapine
 Psychotic Disorders
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
 Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009



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