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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00212771
First received: September 13, 2005
Last updated: June 18, 2014
Last verified: June 2014
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00212771     History of Changes
Other Study ID Numbers: P05846, 25520
Study First Received: September 13, 2005
Last Updated: June 18, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health 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

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

ClinicalTrials.gov processed this record on October 23, 2014