Fixed-dose Safety and Efficacy Study of Asenapine for the Treatment of Schizophrenia (P05688 AM1)

• Conditions: Schizophrenia; MedDRA version: 17.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2010-018407-28-BG
• Lead Sponsor: Schering-Plough Research Institute, a Division of Schering

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-29
• Last Update Posted: 2 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 355

Inclusion Criteria

• Each subject must be at least 18 years of age and of legal minimum age for signing the consent form.
• Each subject must have a current diagnosis of schizophrenia of paranoid (295.30), disorganized (295.10), or undifferentiated (295.90) subtype.
• Each subject must have a minimum PANSS total score of 70 at Screening and Baseline.
• Each subject must have a score of at least 4 (moderate) in two or more of the five items in the positive subscale of the PANSS (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/persecution) at Screeningand Baseline.
• Each subject must be confirmed (documented in the psychiatric intake evaluation form by the investigator, and reviewed by the sponsor designated medical expert [SDME] prior to randomization) to be experiencing an acute exacerbation of schizophrenia, as evidenced by ALL of the following:
- duration of the current episode is no more than 8 weeks,
- the subject’s current symptoms represent a marked and substantial change compared with the subject’s symptomatic state prior to the emergence of the current episode.
- the subject is in need of increased medical attention to treat worsening positive symptoms
• Each subject must taper off all prohibited psychotropic medications (including antipsychotics, antidepressants, and mood stabilizers) with last dose taken no later than the evening prior to Baseline (the dosing cycle of depot neuroleptics must end no later than the day prior to Baseline). For subjects who skip the tapering period, tapering off must be done, with last dose taken no later than the day of Screening (the dosing cycle of depot neuroleptics must end no later than the day of Screening).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 290
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 64

Exclusion Criteria

A subject must not have a past or current diagnosis of schizoaffective disorder (295.70), schizophrenia of residual subtype (295.60) or schizophrenia of catatonic subtype (295.20) as determined by the investigator and must not have a current diagnosis of schizophrenia with course specifiers
continuous, single episode in partial remission, or single episode in full remission.
• A subject must not have a primary Axis I diagnosis other than schizophrenia and must not have a
comorbid Axis I diagnosis that is primarily responsible for current symptoms and functional impairment.
• A subject must not have a known diagnosis of borderline personality disorder.
• A subject must not currently (within the past 6 months) meet the DSM-IV-TRTM criteria for substance
abuse or dependence (excluding nicotine).
• A subject must not be at imminent risk of self-harm or harm to others, in the investigator’s opinion based
on clinical interview and responses provided on the Columbia Suicide Severity Rating Scale (C-SSRS).
Note that subjects must be excluded at Screening if they report suicidal ideation of Type 4 or 5 (ie, suicidal ideation with intent, with or without a plan) in the past 2 months or suicidal behavior in the past 6 months as measured by the C-SSRS; subjects must be excluded at Baseline if they report suicidal ideation of Type 4 or 5 or suicidal behavior, as measured by the C-SSRS between Screening and Baseline.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified