Overview

This trial is active, not recruiting.

Condition schizophrenia
Phase phase 4
Sponsor Janssen-Cilag Ltd.
Start date August 2014
End date June 2017
Trial size 362 participants
Trial identifier NCT02874560, CR103490, R092670SCH4033

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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).

Primary Outcomes

Measure
Clinical Remission
time frame: 1 year Follow up
Functional Remission
time frame: 1 year Follow up

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 37 years old.

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

Additional Information

Official title Evaluation of the Functional Remission Occurrence and Predictive Factors in Schizophrenia
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Janssen-Cilag Ltd..