A Study of the Efficacy and Safety of Asenapine in Participants With an Acute Exacerbation of Schizophrenia (P05688 AM2)

This study is currently recruiting participants.
Verified April 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01617187
First received: June 8, 2012
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

The purpose of this trial is to assess the effect of asenapine 2.5 and 5 mg sublingually twice daily (BID) compared with placebo in the treatment of schizophrenia (overall symptoms) as measured by the Positive and Negative Syndrome Scale (PANSS). Olanzapine administered 15 mg orally once daily (QD) was used as an active control.


Condition Intervention Phase
Schizophrenia
Drug: Asenapine
Drug: Placebo Asenapine
Drug: Olanzapine
Drug: Placebo Olanzapine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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 Olanzapine as an Active 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:
  • Change From Baseline to Day 42 in Positive and Negative Syndrome Scale (PANSS) Total Score [ Time Frame: Baseline, Day 42 ] [ Designated as safety issue: No ]
    PANSS is a 30-item instrument for assessing symptoms of schizophrenia composed of 3 subscales: Positive (7 items), Negative (7 items), and General Psychopathology (16 items). Symptoms rated 1-7 points (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate-severe, 6=severe, and 7=extreme) representing increasing levels of psychopathology. Minimum scores for Positive, Negative, and General subscales= 7, 7, and 16 points respectively; minimum total score=30 points. Maximum scores for Positive, Negative, and General subscales=49, 49 and 112 respectively; maximum total score=210 points


Secondary Outcome Measures:
  • Change from Baseline to Day 42 in Clinical Global Impression - Severity of Illness (CGI-S) Score [ Time Frame: Baseline, Day 42 ] [ Designated as safety issue: No ]
    The CGI-S scale is a clinical instrument which rates the overall severity of any mental disorder and refers to the global impression of the patient. It is rated according to the clinical judgement of the physician in routine professional practice on a scale for the overall current severity of symptoms from 1 (healthy, not ill) to 7 (among the most severely ill).

  • Number of Participants with ≥30% Reduction in PANSS Total Score (Responders) at Day 42 [ Time Frame: Baseline to Day 42 ] [ Designated as safety issue: No ]
    PANSS is a 30-item instrument for assessing symptoms of schizophrenia composed of 3 subscales: Positive (7 items), Negative (7 items), and General Psychopathology (16 items). Symptoms rated 1-7 points (1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate-severe, 6=severe, and 7=extreme) representing increasing levels of psychopathology. Minimum scores for Positive, Negative, and General subscales= 7, 7, and 16 points respectively; minimum total score=30 points. Maximum scores for Positive, Negative, and General subscales=49, 49 and 112 respectively; maximum total score=210 points


Estimated Enrollment: 354
Study Start Date: December 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Asenapine 2.5 mg BID Drug: Asenapine
2.5 mg or 5 mg fast dissolving active asenapine tablets administered sublingually, same number of tablets are taken in the morning and the evening
Drug: Placebo Olanzapine
15 mg film-coated placebo olanzapine tablets administered orally QD. The time of the active olanzapine dose (either morning or evening) is not disclosed in order to preserve blinding.
Experimental: Asenapine 5 mg BID Drug: Asenapine
2.5 mg or 5 mg fast dissolving active asenapine tablets administered sublingually, same number of tablets are taken in the morning and the evening
Drug: Placebo Olanzapine
15 mg film-coated placebo olanzapine tablets administered orally QD. The time of the active olanzapine dose (either morning or evening) is not disclosed in order to preserve blinding.
Active Comparator: Olanzapine 15 mg QD Drug: Placebo Asenapine
2.5 mg or 5 mg fast dissolving placebo asenapine tablets administered sublingually, same number of tablets are taken in the morning and the evening
Drug: Olanzapine
15 mg film-coated active olanzapine tablets administered orally QD. The time of the active olanzapine dose (either morning or evening) is not disclosed in order to preserve blinding.
Drug: Placebo Olanzapine
15 mg film-coated placebo olanzapine tablets administered orally QD. The time of the active olanzapine dose (either morning or evening) is not disclosed in order to preserve blinding.
Placebo Comparator: Placebo Drug: Placebo Asenapine
2.5 mg or 5 mg fast dissolving placebo asenapine tablets administered sublingually, same number of tablets are taken in the morning and the evening
Drug: Placebo Olanzapine
15 mg film-coated placebo olanzapine tablets administered orally QD. The time of the active olanzapine dose (either morning or evening) is not disclosed in order to preserve blinding.

Detailed Description:

The trial consists of a screening/tapering period, treatment period, and follow-up period. The 6-week active treatment period includes an inpatient phase and outpatient phase. Participants who complete the trial may continue treatment under a long-term extension protocol (P05689). Participants who do not continue in the treatment continuation trial (whether they complete the 6-week trial or discontinue prematurely) will have a follow-up visit 7 days after their last dose of trial medication.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current diagnosis of schizophrenia of paranoid, disorganized, or undifferentiated subtype
  • Minimum PANSS total score of 70 at Screening and Baseline
  • Score of at least 4 (moderate) in two or more of the five items in the positive subscale of the PANSS
  • Confirmed to be experiencing an acute exacerbation of schizophrenia
  • CGI-S scale score of at least 4 (moderately ill) at Baseline
  • Has responded positively to an antipsychotic medication other than clozapine (Clozaril®) in a prior episode

Exclusion Criteria:

  • Body mass index (BMI) <18.5 or >40.0 kg/m^2
  • Laboratory and/or clinical evidence of clinically significant hepatic conditions
  • Known history of, or undergoing treatment for, narrow angle glaucoma
  • Diagnosed with epilepsy or has had any seizure disorder beyond childhood febrile seizures
  • Known serological evidence of human immunodeficiency virus (HIV) antibody
  • History of neuroleptic malignant syndrome or tardive dyskinesias
  • Past or current diagnosis of schizoaffective disorder, schizophrenia of residual subtype, schizophrenia of catatonic subtype, current diagnosis of schizophrenia with course specifiers continuous, single episode in partial remission, or single episode in full remission, or borderline personality disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01617187

Contacts
Contact: Toll Free Number 1-888-577-8839

  Show 25 Study Locations
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01617187     History of Changes
Other Study ID Numbers: P05688, 2010-018407-28
Study First Received: June 8, 2012
Last Updated: April 22, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 22, 2014