Efficacy and Safety of Asenapine With Placebo and Haloperidol (41023)(COMPLETED) - Full Text View

Sponsored by:	Organon
Information provided by:	Organon
ClinicalTrials.gov Identifier:	NCT00156104

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 inbalance in dopamine and serotonin. This is a 6-week trial to test the efficacy and safety of asenapine, compared with placebo, using an active comparator agent (haloperidol) in the treatment of patients with an acute exacerbation of schizophrenia. Patients who complete the 6-week trial will have the option of continuing in an additional one year extension trial.

Condition	Intervention	Phase
Schizophrenia	Drug: Asenapine Drug: Haloperidol Other: Placebo arm	Phase III

MedlinePlus related topics: Schizophrenia

Drug Information available for: Haloperidol Haloperidol decanoate

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 Haloperidol Positive Control in Subjects With an Acute Exacerbation of Schizophrenia

Further study details as provided by Organon:

Primary Outcome Measures:

Improvement in schizophrenia (change in total PANSS score) from baseline to endpoint (LOCF/MMRM) [ Time Frame: Primary outcome measured weekly for 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Other dimensions of schizophrenia (positive, negative, disorganized thought, hostility/excitement, anxiety/depression, and general psychopathology) CGI-S; CGI-I [ Time Frame: At weekly intervals throughout the 6-week trial. ] [ Designated as safety issue: Yes ]
Neurocognition and cognitive functioning [ Time Frame: Baseline and Endpoint ( Day 42) ] [ Designated as safety issue: Yes ]
CDSS [ Time Frame: Days 21 and 42(Endpoint). ] [ Designated as safety issue: Yes ]
Suicidal thinking ( ISST modified) [ Time Frame: Days 14 and 42 (Endpoint) ] [ Designated as safety issue: Yes ]
Quality of life and patient functionality (QLS; Q-LES-Q ;PETIT0; Physical exam; Pregnancy test [ Time Frame: Baseline and Day 42(Endpoint) ] [ Designated as safety issue: Yes ]
Readiness to discharge [ Time Frame: At weekly intervals during the 6-week trial ] [ Designated as safety issue: Yes ]
EPS ( AIMS; BARS; SARS) [ Time Frame: At weekly intervals during the 6-week triaL ] [ Designated as safety issue: No ]
Labs; Vital Signs; Weight and girth; ECG [ Time Frame: Days 14; 28 and 42 (Endpoint) ] [ Designated as safety issue: Yes ]
Safety and Tolerability [ Designated as safety issue: Yes ]

Enrollment:	460
Study Start Date:	July 2005
Study Completion Date:	October 2006
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Asenapine 5 mg BID	Drug: Asenapine 5 mg BID
2: Experimental Asenapine 10 mg BID	Drug: Asenapine 10 mg BID
3: Active Comparator Haloperidol 4m mg BID	Drug: Haloperidol 4 mg BID
4: Placebo Comparator placebo	Other: Placebo arm

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 pyschiatric 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:	41023, Hera
Study First Received:	September 7, 2005
Last Updated:	August 18, 2008
ClinicalTrials.gov Identifier:	NCT00156104
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Haloperidol
Schizophrenia
Haloperidol decanoate
Dopamine

Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants

Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009