F17464 in Acute Schizophrenia Trial

Phase 2

Completed

• Conditions: Schizophrenia
• Interventions: Drug: F17464; Drug: Placebo

• Registration Number: NCT02151656
• Lead Sponsor: Pierre Fabre Medicament

Brief Summary

The purpose of this study is to evaluate the potential efficacy of oral F17464 in comparison to placebo over 6 weeks in patients with acute exacerbation of schizophrenia. Study design: double-blind, randomized, placebo-controlled, parallel-groups, fixed-dose design, multicentre study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-28
• Study First Submitted QC: 2014-05-29
• Study First Posted: 2014-05-30
• Study Start: 2014-06
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-12-15
• Last Update Posted: 2016-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

Demographic and other characteristics

• Male or female, 18-64 years of age inclusive
• primary diagnosis of schizophrenia undergoing an acute exacerbation with prominent "active phase" symptoms, as described by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition - Text Revision (DSM IV-TR) using the MINI 6.0 (Mini-International Neuropsychiatric Interview) for schizophrenia and psychotic disorders related to DSM IV-TR
• Well-documented diagnosis of schizophrenia for a minimum of 1 year before the screening visit
• Since the diagnosis of schizophrenia, the average number of hospitalisations should be no higher than 2 per year (the minimum duration of hospitalization should be more than 4 days)
• During the year before Visit 1, maximum 3 acute psychotic episodes that required hospitalization or change of antipsychotic medication or other therapeutic intervention
• Adequate clinical response to well-conducted treatment courses during previous acute episodes. A well conducted treatment course is defined as an antipsychotic treatment with the usual doses for at least 4 weeks

Current acute episode

• Structured Clinical Interview for the Positive And Negative Syndrome Scale (SCI-PANSS) with a PANSS total score ≥ 70 to < 120 (at Visit 1 and 2)
• Rating of at least 4 (moderate) on at least 2 of the following 4 PANSS positive symptoms: delusions, hallucinatory behaviour, conceptual disorganization, suspiciousness/persecution
• Clinical Global Impression of Severity (CGI-S) score ≥ 4 (moderate or severe)
• Antipsychotic initiated for this acute episode and/or ongoing chronic antipsychotic treatment, with a maximum of 2 antipsychotics in total needed to be changed (due to inefficacy or safety reasons)
• Hospitalization and/ or treatment for the current psychotic episode for less than 2 weeks prior to Visit 1
• No significant improvement of PANSS total score between enrolment (Visit 1) and inclusion (Visit 2) corresponding to a score improvement < 20% on positive symptoms subscale

Exclusion Criteria

Related to the pathology

• Patients in their first acute episode of psychosis

• Current schizophrenic episode with predominant negative symptoms

• Patient " known to be refractory " defined as lack of significant improvement (no significant relief of symptoms, and no period of good function) despite adequate courses with at least 3 different antipsychotics medication cycles of an adequate duration (at least 4 weeks) and at adequate dosage during the previous 5 years;

• Schizoaffective disorder, schizophreniform disorder and other psychotic disorders;

• Bipolar I and II disorder

• Pervasive developmental disorder, mental retardation, delirium, dementia, memory impairment and other cognitive disorders that would compromise a reliable assessment according to the investigator's opinion

• Known or suspected borderline or antisocial personality disorder or other DSM IV axis II disorder of sufficient severity to interfere with participation in this study

• History of tardive dyskinesia or chronic extra-pyramidal symptoms (EPS), serotonin syndrome or neuroleptic malignant syndrome

• Major depressive disorder which requires a pharmacological treatment

• At imminent risk of injuring him/herself or others or causing significant damage to property, as judged by the investigator

• Suicidal risk based on the Columbia-Suicide Severity Rating Scale (C-SSRS)

  • Any suicidal behavior in the past year
  • Suicidal ideation of type 4 or 5 in the past month

Related to treatments

• Structured psychotherapy (e.g. cognitive behavioural therapy) started within 6 weeks before visit 1
• Electroconvulsive therapy within 3 months before Visit 1
• Previous lack of response to electroconvulsive therapy
• Treatment ongoing with a depot neuroleptic (even if less than 1 cycle in duration before Visit 1)
• Patient having previous treatment course with clozapine within the 4 months prior to Visit 1
• Requirement of concomitant treatment with any of the prohibited medications
• History of intolerance or hypersensitivity to other drugs of the same chemical class as F17464 or to rescue medications or any history of severe drug allergy or hypersensitivity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
F17464	F17464	Oral administration - During 6 weeks - 4 capsules daily
Placebo	Placebo	Oral administration - During 6 weeks - 4 capsules daily

Primary Outcome Measures

Name	Time	Method
Change of the Positive and Negative Syndrome Scale (PANSS) total score	Day 43	Change from baseline to Day 43 of the PANSS total score