Efficacy and Safety of Asenapine With Placebo and Olanzapine - Full Text View

Purpose

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.

Asenapine is an investigational drug that may help to correct the imbalance in dopamine and serotonin. This is a 6 week study to test the efficacy and safety of asenapine and a comparator agent (olanzapine) in the treatment of patients with schizophrenia. Patients that complete this trial will have the option of continuing in an additional one year extension trial.

Condition	Intervention	Phase
Schizophrenia	Drug: asenapine Drug: Placebo Drug: olanzapine	Phase III

MedlinePlus related topics:

Schizophrenia

ChemIDplus related topics:

Olanzapine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Multicenter, Randomized, Double-Blind, Fixed-Dose, 6-Week Trial of the Efficacy and Safety of Asenapine Compared With Placebo Using Olanzapine Positive Control in Subjects With an Acute Exacerbation of Schizophrenia

Further study details as provided by Organon:

Primary Outcome Measures:

Change in total PANSS score at endpoint (6-week double-blind or last assessment after baseline) from baseline [ Time Frame: Screen, baseline, Days 4,7,14,21,28,35,42 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in PANSS subscale and Marder factor scores; CGI-S scores [ Time Frame: Screen, baseline, Days 4,7,14,21,28,35,42 ] [ Designated as safety issue: No ]
CGI-I scores [ Time Frame: Days 4,7,14,21,28,35,42 ] [ Designated as safety issue: No ]
Neurocognition and cognitive functioning [ Time Frame: Baseline , day 42 ] [ Designated as safety issue: No ]
Anxiety [ Time Frame: Baseline, day 42 ] [ Designated as safety issue: No ]
Suicidal thinking [ Time Frame: Baseline, day 42 ] [ Designated as safety issue: No ]
Quality of life and patient functionality [ Time Frame: Baseline, day 42 ] [ Designated as safety issue: No ]
Readiness to discharge, at scheduled assessments and endpoint from baseline [ Time Frame: Baseline up to day 14 ] [ Designated as safety issue: No ]
Extrapyramidal symptoms [ Time Frame: Baseline, Days 4,7,14,21,28,35,42 ] [ Designated as safety issue: Yes ]
Laboratory parameters [ Time Frame: Baseline, Days 14,,28,,42 ] [ Designated as safety issue: Yes ]
Vital signs [ Time Frame: Baseline, Days ,14,21,28,42 ] [ Designated as safety issue: Yes ]
Weight [ Time Frame: Baseline, Days 14,,28,,42 ] [ Designated as safety issue: No ]
ECGs [ Time Frame: Baseline, Days ,14,,28,,42 ] [ Designated as safety issue: Yes ]
Adverse events (including serious adverse events) [ Time Frame: Screen, baseline, Days 4,7,14,21,28,35,42 and are are recorded continuously for AEs up to 7 days after endpoint ] [ Designated as safety issue: Yes ]
SAEs up to 30 days after endpoint [ Time Frame: Screen, baseline, Days 4,7,14,21,28,35,42 and are are recorded continuously for AEs up to 30 days after endpoint ] [ Designated as safety issue: Yes ]

Enrollment:	417
Study Start Date:	May 2005
Study Completion Date:	May 2006
Primary Completion Date:	April 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental asenapine 5 mg BID and 10 mg BID	Drug: asenapine 5 mg BID or 10mg BID
2: Placebo Comparator Placebo against olanzapine and asenapine	Drug: Placebo Placebo
3: Active Comparator olanzapine 15 mgQD	Drug: olanzapine olanzapine 15 mg QD

Eligibility

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

Criteria

Inclusion Criteria:

Currently suffering from an acute exacerbation of schizophrenia. Caregiver required.

Exclusion Criteria:

Have an uncontrolled, unstable medical condition. Have any other psychiatric disorder other than schizophrenia as a primary diagnosis.

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	NV Organon, part of Schering-Plough Corporation ( Study Director )
Study ID Numbers:	41021, Hera
First Received:	September 8, 2005
Last Updated:	August 25, 2008
ClinicalTrials.gov Identifier:	NCT00156117
Health Authority:	United States: Food and Drug Administration

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

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

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Organon
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00156117