Long-term Study of Asenapine in Subjects With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (P06238)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01244828
First received: November 18, 2010
Last updated: October 1, 2014
Last verified: October 2014
  Purpose

This is a multi-site, open-label fixed-flexible dose long-term study of asenapine in subjects with schizophrenia. Participants in this study consist of schizophrenia with residual subtype or receiving high dose/multiple antipsychotic drugs, treatment refractory, or elderly participants with schizophrenia. The treatment period is up to 52 weeks.


Condition Intervention Phase
Schizophrenia
Drug: Asenapine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-term Study of Asenapine in Subjects With Residual Subtype, Receiving Multiple or/and High Dose Drugs, or Treatment Refractory Schizophrenia (Protocol P06238)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Weight gain [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    Weight gain from baseline

  • BMI [ Time Frame: Change in BMI from baseline ] [ Designated as safety issue: Yes ]
    52 weeks

  • EPS [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    Occurrences of extrapyramidal symptoms (EPS)

  • HbA1c [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    Change in HbA1c from baseline

  • Fasting glucose [ Time Frame: 52 Weeks ] [ Designated as safety issue: Yes ]
    Change in fasting glucose from baseline

  • Insulin [ Time Frame: 52 Weeks ] [ Designated as safety issue: Yes ]
    Change in insulin from baseline

  • Prolactin [ Time Frame: 52 Weeks ] [ Designated as safety issue: Yes ]
    Changes in prolactin level from baseline.


Enrollment: 157
Study Start Date: April 2011
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Asenapine
Asenapine 5 mg twice daily (bid) for the first week of treatment, then either 5 mg or 10 mg bid.
Drug: Asenapine
5 mg or 10 mg fast-dissolving tablets bid for up to 52 weeks

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Minimum age of 20 years
  • Subjects who meet at least one of the following:

    • current diagnosis of schizophrenia of residual subtype
    • received treatment with 3 or more antipsychotic drugs
    • treatment-refractory patients with schizophrenia
    • 65 years old and over with positive schizophrenia symptoms with score of 3 (mild) or more in 1 or more items in the positive subscale of the Positive and Negative Syndrome Scale (PANSS) at the baseline
  • Subjects who have a Clinical Global Impressions-Severity (CGI-S) score of at least 4 (moderately ill) at the baseline

Exclusion Criteria:

  • Uncontrolled, unstable clinically significant medical condition
  • Clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram (ECG) findings at Screening
  • Positive pregnancy test at Screening, or the intention to become pregnant during the course of the study
  • Seizure disorder beyond childhood (12 years old or younger)
  • History of neuroleptic malignant syndrome
  • Allergy or sensitivity to drugs such as psychotropics and antipsychotics
  • Known history of or currently treated for narrow angle glaucoma
  • Parkinson's disease
  • Diagnosis of schizoaffective disorder; schizophrenia form disorder
  • Concurrent psychiatric disorder than schizophrenia coded on Axis I; a primary diagnosis other than schizophrenia
  • Diagnosis of borderline personality disorder
  • Diagnosis of mental retardation or organic brain disorder
  • Current (past 6 months) substance abuse or dependence according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria (excluding nicotine)
  • Positive drug/alcohol tests at the Screening visit
  • Imminent risk of self-harm or harm to others, in the investigator's opinion
  • Substance induced psychotic disorder or a behavioral disturbance thought to be due to substance abuse
  • Currently under involuntary inpatient confinement
  • Use of a non-approved drug in Japan within 12 weeks prior to informed consent
  • Previously treated in an asenapine study
  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: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01244828     History of Changes
Other Study ID Numbers: P06238, 132325
Study First Received: November 18, 2010
Last Updated: October 1, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Asenapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on October 19, 2014