Efficacy and Safety of Asenapine With Placebo and Olanzapine (41022)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by:
Organon
ClinicalTrials.gov Identifier:
NCT00151424
First received: September 8, 2005
Last updated: August 25, 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 imbalance in dopamine and serotonin. This is a 6 week study to test the efficacy and safety of asenapine and a comparator agent (olanzapine) in the treatment of patients with schizophrenia. Patients that complete this trial will have the option of continuing in an additional one year extension trial.


Condition Intervention Phase
Schizophrenia
Drug: asenapine
Drug: Placebo
Drug: Olanzapine
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, Flexible-Dose, 6-Week Trial of the Efficacy and Safety of Asenapine Compared With Placebo Using Olanzapine 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:
  • Change in total PANSS score at endpoint (6-week double-blind or last assessment after baseline) from baseline [ Time Frame: Screen, baseline, days 4, 7, 14, 21, 28, 35, 42 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in PANSS subscale and Marder factor score CGI-S scores [ Time Frame: Screen, baseline, Days 4,7,14,21,28,35,42 ] [ Designated as safety issue: No ]
  • CGI-I scores [ Time Frame: Days 4,7,14,21,28,35,42 ] [ Designated as safety issue: No ]
  • Neurocognition and cognitive functioning [ Time Frame: Baseline , day 42 ] [ Designated as safety issue: No ]
  • Anxiety [ Time Frame: Baseline, day 42 ] [ Designated as safety issue: No ]
  • Suicidal thinking [ Time Frame: Baseline, day 42 ] [ Designated as safety issue: No ]
  • Quality of life and patient functionality [ Time Frame: Baseline, day 42 ] [ Designated as safety issue: No ]
  • Readiness to discharge, at scheduled assessments and endpoint from baseline [ Time Frame: Baseline up to day 14 ] [ Designated as safety issue: No ]
  • Extrapyramidal symptoms [ Time Frame: Baseline, Days 4,7,14,21,28,35,42 ] [ Designated as safety issue: Yes ]
  • Laboratory parameters [ Time Frame: Baseline, Days 14,,28,,42 ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: Baseline, Days ,14,21,28,42 ] [ Designated as safety issue: Yes ]
  • Weight [ Time Frame: Baseline, Days 14,,28,,42 ] [ Designated as safety issue: No ]
  • ECGs [ Time Frame: Baseline, Days ,14, 28, 42 ] [ Designated as safety issue: Yes ]
  • Adverse events (including serious adverse events) [ Time Frame: Screen, baseline, Days 4,7,14,21,28,35,42 and are are recorded continuously for AEs up to 7 days after endpoint ] [ Designated as safety issue: Yes ]
  • SAEs up to 30 days after endpoint [ Time Frame: Screen, baseline, Days 4,7,14,21,28,35,42 and are are recorded continuously for AEs up to 30 days after endpoint ] [ Designated as safety issue: Yes ]

Enrollment: 277
Study Start Date: February 2005
Study Completion Date: February 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
asenapine 5-10mg BID
Drug: asenapine
Asenapine 5-10mgBID
Placebo Comparator: 2
Placebo
Drug: Placebo
Matched against asenapine and olanzapine
Active Comparator: 3
olanzapine 10-20 mg QD
Drug: Olanzapine
10-20 mg QD

  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.

Exclusion Criteria:

  • Have an uncontrolled, unstable medical condition. Have any other psychiatric 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: NCT00151424     History of Changes
Other Study ID Numbers: 41022, Hera
Study First Received: September 8, 2005
Last Updated: August 25, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Asenapine
Olanzapine
Antiemetics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 21, 2014