Efficacy and Safety of Asenapine With Placebo and Haloperidol (41023)(COMPLETED)

Condition(s) targeted: Schizophrenia

Intervention: Asenapine (Drug); Asenapine (Drug); Haloperidol (Drug); Placebo arm (Other)

Phase: Phase 3

Status: Completed

Sponsored by: Organon

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Improvement in schizophrenia (change in total PANSS score) from baseline to endpoint (LOCF/MMRM)

Secondary outcome:

Other dimensions of schizophrenia (positive, negative, disorganized thought, hostility/excitement, anxiety/depression, and general psychopathology) CGI-S; CGI-I

Neurocognition and cognitive functioning

CDSS

Suicidal thinking ( ISST modified)

Quality of life and patient functionality (QLS; Q-LES-Q ;PETIT0; Physical exam; Pregnancy test

Readiness to discharge

EPS ( AIMS; BARS; SARS)

Labs; Vital Signs; Weight and girth; ECG

Safety and Tolerability

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Starting date: July 2005
Last updated: August 18, 2008