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Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25520)(COMPLETED) (ACTAMESA)
This study has been completed.
First Received: September 13, 2005   Last Updated: August 8, 2008   History of Changes
Sponsored by: Organon
Information provided by: Organon
ClinicalTrials.gov Identifier: NCT00212771
  Purpose

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

MedlinePlus related topics: Schizophrenia
Drug Information available for: Org 5222 Olanzapine
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: 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

Further study details as provided by Organon:

Primary Outcome Measures:
  • Change in total PANSS score at endpoint [ Time Frame: Screening, Week 76, 100, and once every 24 weeks thereafter until endpoint ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in PANSS subscale scores and Marder factor scores [ Time Frame: Every 24 weeks after baseline ] [ Designated as safety issue: No ]
  • Changes in CGI-S [ Time Frame: Every 12 weeks after baseline ] [ Designated as safety issue: No ]
  • Patient functionality and subjective well-being (as measured by LOF, SF-12 and SWN) [ Time Frame: Every 48 weeks after baseline ] [ Designated as safety issue: No ]
  • Severity of depressed mood (as measured by the Calgary Depression Scale for Schizophrenia) [ Time Frame: Every 24 weeks after baseline ] [ Designated as safety issue: No ]
  • Resource utilization (as measured by frequency and length of hospital stay) [ Time Frame: During the entire study period ] [ Designated as safety issue: No ]
  • Safety and tolerability: EPS (AIMS, BARS, SARS) [ Time Frame: Every 24 weeks after baseline ] [ 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 Tests [ Time Frame: Every 12 weeks after baseline ] [ Designated as safety issue: No ]
  • Weight and vital signs [ Time Frame: Every 4 weeks after baseline ] [ Designated as safety issue: No ]
  • ECGs [ Time Frame: Every 24 weeks after baseline ] [ Designated as safety issue: No ]

Enrollment: 440
Study Start Date: September 2004
Study Completion Date: October 2006
Primary Completion Date: September 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
Flexible dose, 1-2 capsules oral once per day (in the morning). Each capsule contains 10 mg olanzapine or matching placebo.

  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. 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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers: 25520
Study First Received: September 13, 2005
Last Updated: August 8, 2008
ClinicalTrials.gov Identifier: NCT00212771     History of Changes
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;   Slovenia: Agency for Medicinal Products - Ministry of Health;   United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:
Neurotransmitter Agents
Tranquilizing Agents
Olanzapine
Psychotropic Drugs
Central Nervous System Depressants
Antiemetics
Antipsychotic Agents
Serotonin Uptake Inhibitors
Serotonin
Schizophrenia
Mental Disorders
Psychotic Disorders
Peripheral Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

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

ClinicalTrials.gov processed this record on May 07, 2009