Efficacy and Safety of Asenapine With Placebo and Haloperidol (41023)(P05926)(COMPLETED)

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Asenapine; Drug: Asenapine; Drug: Haloperidol; Other: Placebo arm

• Study Type: Interventional
• Enrollment (Actual): 460
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Asenapine 5 mg BID	Drug: Asenapine; 5 mg BID; Drug: Asenapine; 10 mg BID
Experimental: 2; Asenapine 10 mg BID	Drug: Asenapine; 5 mg BID; Drug: Asenapine; 10 mg BID
Active Comparator: 3; Haloperidol 4m mg BID	Drug: Haloperidol; 4 mg BID
Placebo Comparator: 4; placebo	Other: Placebo arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement in schizophrenia (change in total PANSS score) from baseline to endpoint (LOCF/MMRM)	Primary outcome measured weekly for 6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Other dimensions of schizophrenia (positive, negative, disorganized thought, hostility/excitement, anxiety/depression, and general psychopathology) CGI-S; CGI-I	At weekly intervals throughout the 6-week trial.
Neurocognition and cognitive functioning	Baseline and Endpoint ( Day 42)
CDSS	Days 21 and 42(Endpoint).
Suicidal thinking ( ISST modified)	Days 14 and 42 (Endpoint)
Quality of life and patient functionality (QLS; Q-LES-Q ;PETIT0; Physical exam; Pregnancy test	Baseline and Day 42(Endpoint)
Readiness to discharge	At weekly intervals during the 6-week trial
EPS ( AIMS; BARS; SARS)	At weekly intervals during the 6-week triaL
Labs; Vital Signs; Weight and girth; ECG	Days 14; 28 and 42 (Endpoint)
Safety and Tolerability

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General Publications

• Kane JM, Cohen M, Zhao J, Alphs L, Panagides J. Efficacy and safety of asenapine in a placebo- and haloperidol-controlled trial in patients with acute exacerbation of schizophrenia. J Clin Psychopharmacol. 2010 Apr;30(2):106-15. doi: 10.1097/JCP.0b013e3181d35d6b.
• Castle DJ, Slott Jensen JK. Management of depressive symptoms in schizophrenia. Clin Schizophr Relat Psychoses. 2015 Apr;9(1):13-20. doi: 10.3371/CSRP.CAJE.103114.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2005
• Primary Completion (Actual): August 18, 2006
• Study Completion (Actual): September 16, 2006

Study Registration Dates

• First Submitted: September 7, 2005
• First Submitted That Met QC Criteria: September 9, 2005
• First Posted (Estimate): September 12, 2005

Study Record Updates

• Last Update Posted (Actual): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Dopamine Agents; Dopamine Antagonists; Anti-Dyskinesia Agents; Asenapine; Haloperidol; Haloperidol decanoate
• Other Study ID Numbers: P05926; HerA; 41023

Plan for Individual participant data (IPD)

Study Data/Documents

1. CSR Synopsis