NCT02151656

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P50-P75 for phase_2 schizophrenia

Timeline
Completed

Started Jun 2014

Geographic Reach
5 countries

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2014

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 16, 2016

Status Verified

January 1, 2016

Enrollment Period

1.5 years

First QC Date

May 28, 2014

Last Update Submit

December 15, 2016

Conditions

Schizophrenia

Keywords

SchizophreniaMental disordersAntipsychotic Drugs

Outcome Measures

Primary Outcomes (1)

  • Change of the Positive and Negative Syndrome Scale (PANSS) total score

    Change from baseline to Day 43 of the PANSS total score

    Day 43

Study Arms (2)

F17464

EXPERIMENTAL

Oral administration - During 6 weeks - 4 capsules daily

Drug: F17464

Placebo

PLACEBO COMPARATOR

Oral administration - During 6 weeks - 4 capsules daily

Drug: Placebo

Interventions

F17464DRUG
F17464
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Unknown Facility

Nîmes, France

Location

Unknown Facility

Sotteville-lès-Rouen, France

Location

Unknown Facility

Balassagyarmat, Hungary

Location

Unknown Facility

Budapest, Hungary

Location

Unknown Facility

Gyula, Hungary

Location

Unknown Facility

Daugavpils, Latvia

Location

Unknown Facility

Jelgava, Latvia

Location

Unknown Facility

Liepāja, Latvia

Location

Unknown Facility

Strenči, Latvia

Location

Unknown Facility

Arad, Romania

Location

Unknown Facility

Bucharest, Romania

Location

Unknown Facility

Campulum G Muscel, Romania

Location

Unknown Facility

Craiova, Romania

Location

Unknown Facility

Galati, Romania

Location

Unknown Facility

Iași, Romania

Location

Unknown Facility

Sibiu, Romania

Location

Unknown Facility

Târgovişte, Romania

Location

Unknown Facility

Târgu Mureş, Romania

Location

Unknown Facility

Timișoara, Romania

Location

Unknown Facility

Arkhangelsky District, Russia

Location

Unknown Facility

Engel's, Russia

Location

Unknown Facility

Kazan', Russia

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Orenburg, Russia

Location

Unknown Facility

Saratov, Russia

Location

Unknown Facility

Tomsk, Russia

Location

Unknown Facility

Yekaterinburg, Russia

Location

MeSH Terms

Conditions

SchizophreniaMental Disorders

Interventions

dopamine D3 receptor antagonist F17464

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

  • Françoise TONNER, MD

    Pierre Fabre Medicament

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2014

First Posted

May 30, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 16, 2016

Record last verified: 2016-01

Locations

LA(4)RO(10)RU(8)FR(2)HU(3)