Long-Term Efficacy and Safety of Asenapine Using Olanzapine as a Positive Control (41512)(COMPLETED)(P05784)

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: NCT00156091
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : August 11, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:

Schizophrenia is a brain disease. The primary features of schizophrenia are characterized by Positive symptoms (symptoms that should not be there, inability to think clearly, to distinguish reality from fantasy i.e., hearing voices) and Negative symptoms (a reduction or absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and relate to others). Other symptoms include reduced ability to recall and learn new information, difficulty with problem solving, or maintaining productive employment. The symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other.

The clinical development of asenapine, as described in the 2007 IDB appears to have antipsychotic activity with superior symptomatic control compared to placebo and an improved safety profile compared to currently available neuroleptics. Its fast dissolving formulation may further add to treatment compliance. While various titration schedules have been used in previous studies, dose increases at 5 mg BID up to 10 mg BID have been well tolerated. Therefore, further exploration in a larger group of subjects with acute exacerbation of schizophrenia using an asenapine flexible dosing design ( 5 or 10 mg BID) will mimic actual clinical practice in a long-term 52-week extension trial.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Olanzapine Drug: Asenapine Other: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Flexible-Dose, Long-Term Extension Trial of the Safety and Maintenance of Effect of Asenapine Using Olanzapine Positive Control in Subjects Who Complete Protocols 041021 or 041022.
Study Start Date : April 2005
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Olanzapine 20 mg QD
Drug: Olanzapine
5- 20 mg QD
Experimental: 2
Asenapine 5 or 10 mg BID
Drug: Asenapine
5 or 10 mg BID
Double-Blind subjects randomized to only placebo medication for 6 weeks in the short-term 041021 or 041022 asenapine trials, were randomized (double-blind) Into the long-term 041512 asenapine extension trial and received asenapine 5 mg BID for Week 1. After Week 1, subjects received asenapine (either 5 mg BID or 10 mg BID) for the remainder of the 52 week trial.
Other: Placebo

Primary Outcome Measures :
  1. To assess long-term safety including overall symptoms (AEs; SAEs); Vital signs; ISST; EPS; and maintenance of effect; for asenapine with haloperidol control. [ Time Frame: Weeks 1;2; 4; 8; 12; 16; 24; 32; 40; 52 (Endpoint) ]
  2. Quality of Life and Patient Functionality (QLS; Q-LES-Q and PETIT) [ Time Frame: Weeks 16; 32; 52(Endpoint) ]

Secondary Outcome Measures :
  1. Pregnancy tests; Lab tests [ Time Frame: Weeks 8; 16; 32; 52 (Endpoint) ]
  2. Physical exams [ Time Frame: Week 12; 24; 52 (Endpoint) ]
  3. Neurocognition and cognitive functioning [ Time Frame: Weeks 24 and 52 (Endpoint) ]
  4. Weight and abdominal girth [ Time Frame: Weeks 4;8;12; 16; 24; 32;40;52(Endpoint) ]
  5. ECGs [ Time Frame: Weeks 2;4;8;24;52(Endpoint) ]
  6. Depression (CDSS) [ Time Frame: Weeks 12; 24; 52 (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:

  • Completed the short-term trial ( 041021 or 021022)
  • Continued to meet all demographic and procedural inclusion criteria of the short-term trial upon entry into this long-term extension trial
  • Sign a written informed consent for the 041512 trial.
  • Demonstrated an acceptable degree of compliance with trial medication in the short-term trials in the opinion of the investigator

Exclusion Criteria:

  • CGI-S score of greater or equal to 6 ( severely psychotic)
  • Occurrence(s) of AE or other clinically significant findings that would prohibit their continuation
  • Met any of exclusion criteria regarding medical/psychiatric status listed in the short-term trials ( 041021 or 041022)
  • Met exclusion criteria for medication status in short-term trials except for antidepressants and mood stabilizers.

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00156091     History of Changes
Other Study ID Numbers: P05784
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: August 11, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
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