6-week Trial of the Efficacy and Safety of Asenapine Compared to Placebo in Subjects With an Acute Exacerbation of Schizophrenia (Study P06124)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01098110
First received: April 1, 2010
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

A multicenter, randomized, parallel-group, double-blind, fixed dose, 6-week trial of the efficacy and safety of asenapine compared with placebo in subjects with an acute exacerbation of schizophrenia.


Condition Intervention Phase
Schizophrenia
Drug: Asenapine 5 mg
Drug: Asenapine 10 mg
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: 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 in Subjects With an Acute Exacerbation of Schizophrenia (Phase 3; P06124)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Efficacy of asenapine 5 mg and 10 mg BID compared to placebo based on change from Baseline in PANSS total score. [ Time Frame: Day 42 ] [ Designated as safety issue: No ]

Enrollment: 531
Study Start Date: May 2010
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Asenapine 5 mg Drug: Asenapine 5 mg
Asenapine 5 mg fast dissolving tablets sublingually without water twice daily, in the morning (around 8 am) and in the evening (around 8 pm), for 6 weeks.
Other Name: SCH 900274
Experimental: Asenapine 10 mg Drug: Asenapine 10 mg

Asenapine 10 mg fast dissolving tablets sublingually without water twice daily, in the morning (around 8 am) and in the evening (around 8 pm), for 6 weeks.

Subjects in the asenapine 10 mg arm will receive 5 mg BID on Day 1, then 10 mg BID thereafter.

Other Name: SCH 900274
Placebo Comparator: Placebo Drug: Placebo
A matching placebo of asenapine sublingual tablet not containing asenapine

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • current diagnosis of schizophrenia of paranoid, disorganized, catatonic, or undifferentiated (295.90) subtype
  • minimum PANSS total score of 60 at screening and Baseline.
  • participant had a score of at least 4 in two or more of 5 items in the positive subscale of the PANSS at Screening and Baseline.
  • participant confirmed by the investigator to be experiencing an acute exacerbation of schizophrenia as evidenced by ALL of the following:

    • at the screening test, the duration of the current episode was no more than 2 months;
    • current symptoms represented a dramatic and substantial change compared to the subject's symptomatic state prior to the emergence of the current episode;
    • participant was in need of changing medication or dosage to treat newly appeared or worsened positive symptoms.
  • participant had a Clinical Global Impressions-Severity (CGI-S) scale score of at least 4 (moderately ill) at Baseline;
  • responded positively to an antipsychotic medication in a prior episode.
  • discontinued the use of all prohibited concomitant medications, with last dose taken no later than the evening prior to the baseline visit (For depot neuroleptic, discontinuation must have occurred more than 3 months prior to randomization).
  • participants must agree to inpatient status for screening period and for up to 42 days of dosing and, for out-patient phase, had a caregiver or an identified responsible person (e.g., family member, social worker, case worker, or nurse) whom the investigator accepts and who has agreed to provide support to the subject to ensure compliance with study treatment, outpatient visits, and protocol procedures.

Exclusion Criteria:

  • not be treatment-refractory defined by the following criteria: (1) had been treated with at least two different atypical anti-psychotic agents at dosages equivalent to or greater than 600 mg/day of chlorpromazine (12 mg /day of haloperidol) for more than 4 weeks, each without clinical response, or (2) has received clozapine for 12 weeks immediately preceding the screening.
  • not have received treatment with 3 or more antipsychotic drugs, or dose-equivalents higher than 18 mg/day of haloperidol (equivalent 900 mg/day of chlorpromazine) within one month prior to randomization.
  • not have a diagnosis of schizoaffective disorder; schizophrenia of residual subtype; schizophreniform disorder, or schizophrenia with course specifiers continuous, single episode in partial remission, or single episode in full remission
  • not have a concurrent psychiatric disorder other than schizophrenia coded on Axis I; not have a primary diagnosis other than schizophrenia
  • not have had a known diagnosis of borderline personality disorder, mental retardation or organic brain disorder.
  • not have a 20% or greater decrease in PANSS total score from screening to baseline
  • not have an imminent risk of self-harm or harm to others, in the investigator's opinion.
  • not have a substance induced psychotic disorder or a behavioral disturbance thought to be due to substance abuse
  • not be currently under involuntary inpatient confinement.
  • not been previously treated with asenapine.
  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: NCT01098110     History of Changes
Other Study ID Numbers: P06124
Study First Received: April 1, 2010
Last Updated: April 25, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on October 29, 2014