Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
158 participants
INTERVENTIONAL
2014-06-30
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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F17464
Oral administration - During 6 weeks - 4 capsules daily
F17464
Placebo
Oral administration - During 6 weeks - 4 capsules daily
Placebo
Interventions
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F17464
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
64 Years
ALL
No
Sponsors
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Pierre Fabre Medicament
INDUSTRY
Responsible Party
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Principal Investigators
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Françoise TONNER, MD
Role: STUDY_DIRECTOR
Pierre Fabre Medicament
Locations
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Nîmes, , France
Sotteville-lès-Rouen, , France
Balassagyarmat, , Hungary
Budapest, , Hungary
Gyula, , Hungary
Daugavpils, , Latvia
Jelgava, , Latvia
Liepāja, , Latvia
Strenči, , Latvia
Arad, , Romania
Bucharest, , Romania
Campulum G Muscel, , Romania
Craiova, , Romania
Galati, , Romania
Iași, , Romania
Sibiu, , Romania
Târgovişte, , Romania
Târgu Mureş, , Romania
Timișoara, , Romania
Arkhangelsky District, , Russia
Engel's, , Russia
Kazan', , Russia
Moscow, , Russia
Orenburg, , Russia
Saratov, , Russia
Tomsk, , Russia
Yekaterinburg, , Russia
Countries
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Other Identifiers
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2013-005451-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
F17464 GE 2 01
Identifier Type: -
Identifier Source: org_study_id