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

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Asenapine (Drug); Placebo Asenapine (Drug); Olanzapine (Drug); Placebo Olanzapine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change From Baseline to Day 42 in Positive and Negative Syndrome Scale (PANSS) Total Score

Secondary outcome:

Change from Baseline to Day 42 in Clinical Global Impression - Severity of Illness (CGI-S) Score

Number of Participants with ≥30% Reduction in PANSS Total Score (Responders) at Day 42

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: December 2012
Last updated: October 7, 2014

Page last updated: August 23, 2015

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