Clinical trial NCT02874560: Evaluation of the Functional Remission Occurrence and Predictive Factors in Schizophrenia
Official title: Evaluation of the Functional Remission Occurrence and Predictive Factors in Schizophrenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: CNS
Antipsychotic
Functional remission
Observational study
FROGS
PSP
Functioning
Schizophrenia
Lead sponsor: Janssen-Cilag Ltd.
Sponsor class: INDUSTRY
First posted: 2016-08-22
Enrollment: 364
Sex: ALL
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Clinical Remission
timeFrame: 1 year Follow up
measure: Functional Remission
timeFrame: 1 year Follow up
Secondary outcomes:
measure: Functional Response
timeFrame: 1 year Follow up
measure: Satisfactory Level of Functioning
timeFrame: 1 year Follow up
measure: Predictive Clinical Characteristics
timeFrame: 1 year Follow up
measure: Threshold Score
timeFrame: 1 year Follow up
Other outcomes:
Locations:
city: Paris
country: France
Study officials:
affiliation: Janssen-Cilag Ltd.
name: Janssen-Cilag Ltd. Clinical Trial
role: STUDY_DIRECTOR
References: