SchizophreniaPhase 2FASTNCT02151656
F17464 in Acute Schizophrenia Trial
A Phase 2 study testing F17464 in people with Schizophrenia, run by Pierre Fabre Medicament at 27 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- F17464
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 27 sitesin 5 countries
- Study dates
- Jun 2014to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
27 sites in 5 countries.
27 sites in 5 countries
Romania10 sites
Study site
Arad
Study site
Bucharest
Study site
Campulum G Muscel
Study site
Craiova
Study site
Galati
Study site
Iași
Study site
Sibiu
Study site
Targoviste
Study site
Târgu Mureş
Study site
Timișoara
Russia8 sites
Study site
Arkhangelsky District
Study site
Engel's
Study site
Kazan'
Study site
Moscow
Study site
Orenburg
Study site
Saratov
Study site
Tomsk
Study site
Yekaterinburg
Latvia4 sites
Study site
Daugavpils
Study site
Jelgava
Study site
Liepāja
Study site
Strenči
About this study
Official title: Effects of F17464 in Acute Exacerbation of Schizophrenia
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.
- Conditions
- Schizophrenia
- Being tested
- F17464, Placebo
- Keywords
- Schizophrenia, Mental disorders, Antipsychotic Drugs
- Medical subject headings
- Schizophrenia, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F17464Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| F17464 | Experimental | Oral administration - During 6 weeks - 4 capsules daily Receives: Drug: F17464 |
| Placebo | Placebo comparator | Oral administration - During 6 weeks - 4 capsules daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the Positive and Negative Syndrome Scale (PANSS) total score
Change from baseline to Day 43 of the PANSS total score
Measured: Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Françoise TONNER, MD, Study director, Pierre Fabre Medicament
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02151656
- Sponsor's protocol ID
- F17464 GE 2 01
- Other IDs
- 2013-005451-32
- Acronym
- FAST
- Status last verified
- Jan 2016
- First submitted
- 28 May 2014
- Last updated
- 16 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of F17464 in Acute Exacerbation of Schizophrenia
- ClinicalTrials.gov ID
- NCT02151656
- Acronym / sponsor ID
- FAST / F17464 GE 2 01
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Mental disorders, Antipsychotic Drugs
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F17464 | Experimental | Drug: F17464Oral administration - During 6 weeks - 4 capsules daily |
| Placebo | Placebo comparator | Drug: PlaceboOral administration - During 6 weeks - 4 capsules daily |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (22 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F17464 | Drug | F17464 |
| Placebo | Drug | Placebo |
Primary outcome
Change of the Positive and Negative Syndrome Scale (PANSS) total score
Time frame: Day 43
Change from baseline to Day 43 of the PANSS total score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Françoise TONNER, MD study director
Pierre Fabre Medicament
27 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing F17464 in people with Schizophrenia, run by Pierre Fabre Medicament at 27 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Romania, Russia, Latvia, Hungary, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the Positive and Negative Syndrome Scale (PANSS) total score (time frame: Day 43). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2016.