Evaluation of the Functional Remission Occurrence and Predictive Factors in Schizophrenia

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia

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 Type: Observational
• Enrollment (Actual): 364

Contacts and Locations

Study Locations

• France
  • Paris, France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 37 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1 year Follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1 year Follow up
Predictive Clinical Characteristics	Search for clinical variables predicting an improvement in social performance.	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.	1 year Follow up

Collaborators and Investigators

• Sponsor: Janssen-Cilag Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2014
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): July 12, 2017

Study Registration Dates

• First Submitted: August 17, 2016
• First Submitted That Met QC Criteria: August 17, 2016
• First Posted (Estimate): August 22, 2016

Study Record Updates

• Last Update Posted (Actual): October 22, 2018
• Last Update Submitted That Met QC Criteria: October 19, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Schizophrenia; PSP; Observational study; CNS; Antipsychotic; Functioning; Functional remission; FROGS
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: CR103490; R092670SCH4033 (Other Identifier: Janssen-Cilag Ltd.)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No