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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00212784
First received: September 13, 2005
Last updated: June 18, 2014
Last verified: June 2014
  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 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: 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

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 (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
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

  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
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: NCT00212784     History of Changes
Other Study ID Numbers: P05935, ACTAMESA, 25517
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
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 November 20, 2014