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

This study has been completed.
Sponsor:
Information provided by:
Organon
ClinicalTrials.gov Identifier:
NCT00156104
First received: September 7, 2005
Last updated: August 18, 2008
Last verified: August 2008
  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 3

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

Resource links provided by NLM:


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
Experimental: 1
Asenapine 5 mg BID
Drug: Asenapine
5 mg BID
Experimental: 2
Asenapine 10 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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Study Director, NV Organon, part of Schering-Plough Corporation
ClinicalTrials.gov Identifier: NCT00156104     History of Changes
Other Study ID Numbers: 41023, Hera
Study First Received: September 7, 2005
Last Updated: August 18, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Haloperidol
Haloperidol decanoate
Asenapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents

ClinicalTrials.gov processed this record on September 11, 2014