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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00156104
First Posted: September 12, 2005
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 Merck Sharp & Dohme Corp.:

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 ]

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. ]
  • Neurocognition and cognitive functioning [ Time Frame: Baseline and Endpoint ( Day 42) ]
  • CDSS [ Time Frame: Days 21 and 42(Endpoint). ]
  • Suicidal thinking ( ISST modified) [ Time Frame: Days 14 and 42 (Endpoint) ]
  • Quality of life and patient functionality (QLS; Q-LES-Q ;PETIT0; Physical exam; Pregnancy test [ Time Frame: Baseline and Day 42(Endpoint) ]
  • Readiness to discharge [ Time Frame: At weekly intervals during the 6-week trial ]
  • EPS ( AIMS; BARS; SARS) [ Time Frame: At weekly intervals during the 6-week triaL ]
  • Labs; Vital Signs; Weight and girth; ECG [ Time Frame: Days 14; 28 and 42 (Endpoint) ]
  • Safety and Tolerability

Enrollment: 460
Actual Study Start Date: July 1, 2005
Study Completion Date: September 16, 2006
Primary Completion Date: August 18, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Publications:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00156104     History of Changes
Other Study ID Numbers: P05926
Hera
41023
First Submitted: September 7, 2005
First Posted: September 12, 2005
Last Update Posted: August 22, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Haloperidol
Haloperidol decanoate
Asenapine
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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