SchizophreniaNCT02874560
Evaluation of the Functional Remission Occurrence and Predictive Factors in Schizophrenia
An observational study of Schizophrenia, run by Janssen-Cilag Ltd. at 1 site in France.
Trial summary
In a population of patients suffering from schizophrenia being treated for an episode of clinical destabilization and followed for a period of twelve months, the main objective is to evaluate the proportion of patients achieving functional remission and its relationship to clinical remission. Read more about this study
- Who is it for?
- Ages 18 to 37 years
- Conditions the study is for
- Schizophrenia
- How many people
- 364 participants
- Where
- 1 siteFrance
- Study dates
- 12 Aug 2014to 12 Jul 2017
- Phase
- Observational
- 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 37 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients are followed in hospital, CMP or clinics for at least 6 months and are likely to be followed by the same team within the next year.
Who may be able to join
- Patients must be male or female adult patients aged 18 to 37 years with a diagnosis of schizophrenia according to diagnostic and statistical manual of mental disorders (DSM-IV) criteria
- Treated for schizophrenia
- Having read understood and signed an informed consent (for patients under legal guardianship, the legal guardian will be informed by the physician)
- Patients must have initiated a long-acting injectable antipsychotic treatment less than 2 months after a previous treatment
- Patients must have been under monitoring by a treatment team from a hospital, a medical psychiatric centre or a clinic for at least 6 months and must be likely to be followed by the same team for the next year
Who cannot join
- Resistant schizophrenia (no response after receiving two successive antipsychotic treatments at an effective dose, each over at least a four-week period)
- Drug or alcohol dependence or abuse (other than nicotine or caffeine abuse) diagnosed according to DSM-IV in the month preceding the study inclusion process which according to the investigator could compromise the participation in the study
- History of neuroleptic malignant syndrome
- Inability to comply with the requirements of the study (e.g., intellectual deficiency, inability or unwillingness to answer questionnaires) according to the investigator's opinion
- Patients under trusteeship or patient receiving psychiatric care without his consent (except patient under care program)
- Participation in another study within 30 days prior to the study inclusion period
Trial locations and contacts
1 site in 1 country.
About this study
In a population of patients suffering from schizophrenia being treated for an episode of clinical destabilization and followed for a period of twelve months, the main objective is to evaluate the proportion of patients achieving functional remission and its relationship to clinical remission.
Read the detailed description
Prospective, national, noninterventional study. One year follow up with three evaluation dates (D0, D180 and D360). The participation of a subject in this study will in no way impact the regular care of the subject or any benefits they are otherwise entitled to. All treatment decisions will be made at the discretion of the participating physician, in accordance with his clinical practice and with approved local prescribing information. Only data available from clinical practice will be collected. Evaluation methods: patient history and clinical examination, clinical global impression (CGI): Improvement in CGI, social performance evaluation [functional remission of general schizophrenia (FROGS scale)], clinical remission evaluation: 8 items of the Positive and negative syndrome (PANSS) Scale, psychosocial remission evaluation (PSP scale), current insight evaluation: insight scale for psychosis, subjective well being under neuroleptic treatment (SWN scale), health condition [Euro quality of life - 5 Dimensions (EQ-5D)]; Judgment Criteria: functional remission is defined as an overall score of greater than or equal to (>=) 57 on the FROGS scale, functional response is defined as improvement of >= 7 points on the FROGS scale. Safety evaluation: no tolerance analysis will be performed, adverse event (AE) and serious adverse event (SAE) with J\&J products will be collected and transmitted according to J\&J timelines/process.
- Conditions
- Schizophrenia
- Keywords
- CNS, Antipsychotic, Functional remission, Observational study, FROGS, PSP, Functioning, Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia | 350 patients will be included in the study. The centers selection is planned with 100 hospital-based psychiatrists, in centers for preventive medicine (CMP) or in private settings. Each investigator should consecutively enroll patients fulfilling the selection criteria to participate in the study (mean expected number of participants per center is around 10). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Remission
Defined by the absence of a score greater than (>) 3 on the Positive and Negative Syndrome Scale (PANSS) 8 item scale at two consecutive evaluations (D0 and D180 or D180 and D360). The PANSS 8 items allows to evaluate the clinical remission, defined by a score less than or equal to (=<) 3 on each eight items during a six month minimum period. Each of the 8 PANSS items must be scored from 1 (not at all) to 7 (extremely). More the score is high, more the severity rate of the symptom is high.
Measured: 1 year Follow up
Functional Remission
Defined by Functional Remission of General Schizophrenia (FROGS) scale global score and its relationship with clinical remission. FROGS scale: The "Functional Remission of General Schizophrenia" (FROGS) is a 19 items scale gathered in five fields ("Daily life", "Activities", "Adaptation Quality", "relational Life", "Health and treatment") used to evaluate the functional remission in schizophrenia. The 19 items must be scored from 1(not done) to 5 (perfectly done). The total score is 19 to 95. More the score is high, better the functioning abilities are is high.
Measured: 1 year Follow up
Secondary outcomes (4)
Functional Response
Defined as improvement from baseline of greater than or equal to (>=) 7 points on the FROGS scale. FROGS scale: The "Functional Remission of General Schizophrenia" (FROGS) is a 19 items scale gathered in five fields ("Daily life", "Activities", "Adaptation Quality", "relational Life", "Health and treatment") used to evaluate the functional remission in schizophrenia. The 19 items must be scored from 1(not done) to 5 (perfectly done). The total score is 19 to 95. More the score is high, better the functioning abilities are is high.
Measured: 1 year Follow up
Satisfactory Level of Functioning
Defined by the absence of an item less than (<) 3 on the FROGS scale. FROGS scale: The "Functional Remission of General Schizophrenia" (FROGS) is a 19 items scale gathered in five fields ("Daily life", "Activities", "Adaptation Quality", "relational Life", "Health and treatment") used to evaluate the functional remission in schizophrenia. The 19 items must be scored from 1(not done) to 5 (perfectly done). The total score is 19 to 95. More the score is high, better the functioning abilities are is high.
Measured: 1 year Follow up
Predictive Clinical Characteristics
Search for clinical variables predicting an improvement in social performance.
Measured: 1 year Follow up
Threshold Score
Determine a threshold score to define functional remission, satisfactory functioning and optimal functioning on the Mini FROGS scale. Mini FROGS: 4 of the 19 items of FROGS, also scored from 1 (not done) to 5 (perfectly done), the total score is 4 to 20. More the score is high, better the functioning abilities are high.
Measured: 1 year Follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study start12 Aug 2014
- Primary completion30 Jun 2017
- Study completion12 Jul 2017
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Ltd. Clinical Trial, Study director, Janssen-Cilag Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874560
- Sponsor's protocol ID
- CR103490
- Other IDs
- R092670SCH4033
- Status last verified
- Oct 2018
- First submitted
- 17 Aug 2016
- Last updated
- 22 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Functional Remission Occurrence and Predictive Factors in Schizophrenia
- ClinicalTrials.gov ID
- NCT02874560
- Acronym / sponsor ID
- CR103490
- Conditions
- Schizophrenia
- Keywords
- CNS, Antipsychotic, Functional remission, Observational study, FROGS, PSP, Functioning, Schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Janssen-Cilag Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Aug 2014 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 12 Jul 2017 (actual)
- First posted
- 22 Aug 2016 (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.
In a population of patients suffering from schizophrenia being treated for an episode of clinical destabilization and followed for a period of twelve months, the main objective is to evaluate the proportion of patients achieving functional remission and its relationship to clinical remission.
Detailed description
Prospective, national, noninterventional study. One year follow up with three evaluation dates (D0, D180 and D360). The participation of a subject in this study will in no way impact the regular care of the subject or any benefits they are otherwise entitled to. All treatment decisions will be made at the discretion of the participating physician, in accordance with his clinical practice and with approved local prescribing information. Only data available from clinical practice will be collected. Evaluation methods: patient history and clinical examination, clinical global impression (CGI): Improvement in CGI, social performance evaluation [functional remission of general schizophrenia (FROGS scale)], clinical remission evaluation: 8 items of the Positive and negative syndrome (PANSS) Scale, psychosocial remission evaluation (PSP scale), current insight evaluation: insight scale for psychosis, subjective well being under neuroleptic treatment (SWN scale), health condition [Euro quality of life - 5 Dimensions (EQ-5D)]; Judgment Criteria: functional remission is defined as an overall score of greater than or equal to (>=) 57 on the FROGS scale, functional response is defined as improvement of >= 7 points on the FROGS scale. Safety evaluation: no tolerance analysis will be performed, adverse event (AE) and serious adverse event (SAE) with J\&J products will be collected and transmitted according to J\&J timelines/process.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia | – | –350 patients will be included in the study. The centers selection is planned with 100 hospital-based psychiatrists, in centers for preventive medicine (CMP) or in private settings. Each investigator should consecutively enroll patients fulfilling the selection criteria to participate in the study (mean expected number of participants per center is around 10). |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients are followed in hospital, CMP or clinics for at least 6 months and are likely to be followed by the same team within the next year.
Key inclusion criteria (5 listed)
- Patients must be male or female adult patients aged 18 to 37 years with a diagnosis of schizophrenia according to diagnostic and statistical manual of mental disorders (DSM-IV) criteria
- Treated for schizophrenia
- Having read understood and signed an informed consent (for patients under legal guardianship, the legal guardian will be informed by the physician)
- Patients must have initiated a long-acting injectable antipsychotic treatment less than 2 months after a previous treatment
- Patients must have been under monitoring by a treatment team from a hospital, a medical psychiatric centre or a clinic for at least 6 months and must be likely to be followed by the same team for the next year
Key exclusion criteria (6 listed)
- Resistant schizophrenia (no response after receiving two successive antipsychotic treatments at an effective dose, each over at least a four-week period)
- Drug or alcohol dependence or abuse (other than nicotine or caffeine abuse) diagnosed according to DSM-IV in the month preceding the study inclusion process which according to the investigator could compromise the participation in the study
- History of neuroleptic malignant syndrome
- Inability to comply with the requirements of the study (e.g., intellectual deficiency, inability or unwillingness to answer questionnaires) according to the investigator's opinion
- Patients under trusteeship or patient receiving psychiatric care without his consent (except patient under care program)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Remission
Time frame: 1 year Follow up
Defined by the absence of a score greater than (>) 3 on the Positive and Negative Syndrome Scale (PANSS) 8 item scale at two consecutive evaluations (D0 and D180 or D180 and D360). The PANSS 8 items allows to evaluate the clinical remission, defined by a score less than or equal to (=<) 3 on each eight items during a six month minimum period. Each of the 8 PANSS items must be scored from 1 (not at all) to 7 (extremely). More the score is high, more the severity rate of the symptom is high.
Functional Remission
Time frame: 1 year Follow up
Defined by Functional Remission of General Schizophrenia (FROGS) scale global score and its relationship with clinical remission. FROGS scale: The "Functional Remission of General Schizophrenia" (FROGS) is a 19 items scale gathered in five fields ("Daily life", "Activities", "Adaptation Quality", "relational Life", "Health and treatment") used to evaluate the functional remission in schizophrenia. The 19 items must be scored from 1(not done) to 5 (perfectly done). The total score is 19 to 95. More the score is high, better the functioning abilities are is high.
4 secondary outcomes
Functional Response
Time frame: 1 year Follow up
Satisfactory Level of Functioning
Time frame: 1 year Follow up
Predictive Clinical Characteristics
Time frame: 1 year Follow up
Threshold Score
Time frame: 1 year Follow up
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 22 Oct 2018.
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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.
Janssen-Cilag Ltd. Clinical Trial study director
Janssen-Cilag Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Janssen-Cilag Ltd. at 1 site in France.
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 5 inclusion and 6 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 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Clinical Remission (time frame: 1 year Follow up). The study lists 2 primary outcomes in all. 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 22 Oct 2018.