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

NCT ID: NCT01617187

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-04
• Study Completion Date: 2014-09-09

Brief 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. The primary hypothesis is that at least one of the asenapine doses is superior to placebo in improving schizophrenia symptoms as measured by the change from Baseline in the PANSS total score at Day 42. The first key secondary hypothesis is that at least one of the asenapine doses is superior to placebo in improving schizophrenia symptoms as measured by the change from Baseline in Clinical Global Impression Scale-Severity (CGI-S) score at Day 42. The second key secondary hypothesis is that at least one of the asenapine doses is superior to placebo in improving schizophrenia symptoms as measured by the rate of PANSS responders (≥30% Reduction From Baseline in PANSS Total Score) 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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Asenapine 2.5 mg BID

Group Type: EXPERIMENTAL

Asenapine

Intervention Type: DRUG

2.5 mg or 5 mg fast dissolving active asenapine tablets administered sublingually

Placebo Olanzapine

Intervention Type: DRUG

Film-coated placebo olanzapine tablets (to match 5 and 10 mg active olanzapine tablets) administered orally

Asenapine 5 mg BID

Group Type: EXPERIMENTAL

Asenapine

Intervention Type: DRUG

2.5 mg or 5 mg fast dissolving active asenapine tablets administered sublingually

Placebo Olanzapine

Intervention Type: DRUG

Film-coated placebo olanzapine tablets (to match 5 and 10 mg active olanzapine tablets) administered orally

Olanzapine 15 mg QD

Group Type: ACTIVE_COMPARATOR

Placebo Asenapine

Intervention Type: DRUG

Fast dissolving placebo asenapine tablets (to match 2.5 mg and 5 mg active asenapine tablets) administered sublingually

Olanzapine

Intervention Type: DRUG

5 and 10 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

Placebo Olanzapine

Intervention Type: DRUG

Film-coated placebo olanzapine tablets (to match 5 and 10 mg active olanzapine tablets) administered orally

Placebo BID

Group Type: PLACEBO_COMPARATOR

Placebo Asenapine

Intervention Type: DRUG

Fast dissolving placebo asenapine tablets (to match 2.5 mg and 5 mg active asenapine tablets) administered sublingually

Placebo Olanzapine

Intervention Type: DRUG

Film-coated placebo olanzapine tablets (to match 5 and 10 mg active olanzapine tablets) administered orally

Interventions

Asenapine

2.5 mg or 5 mg fast dissolving active asenapine tablets administered sublingually

Intervention Type: DRUG

Placebo Asenapine

Fast dissolving placebo asenapine tablets (to match 2.5 mg and 5 mg active asenapine tablets) administered sublingually

Intervention Type: DRUG

Olanzapine

5 and 10 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

Intervention Type: DRUG

Placebo Olanzapine

Film-coated placebo olanzapine tablets (to match 5 and 10 mg active olanzapine tablets) administered orally

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Landbloom R, Mackle M, Wu X, Kelly L, Snow-Adami L, McIntyre RS, Mathews M, Hundt C. Asenapine for the treatment of adults with an acute exacerbation of schizophrenia: results from a randomized, double-blind, fixed-dose, placebo-controlled trial with olanzapine as an active control. CNS Spectr. 2017 Aug;22(4):333-341. doi: 10.1017/S1092852916000377. Epub 2016 Nov 8.

Reference Type: RESULT

PMID: 27821210 (View on PubMed)

Other Identifiers

2010-018407-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P05688

Identifier Type: -

Identifier Source: org_study_id