Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 12:48 AM
Study NCT ID:
NCT02874560
Status:
COMPLETED
Last Update Posted:
2018-10-22
First Post:
2016-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Functional Remission Occurrence and Predictive Factors in Schizophrenia
Sponsor:
Janssen-Cilag Ltd.
Organization:
Study Overview
Official Title:
Evaluation of the Functional Remission Occurrence and Predictive Factors in Schizophrenia
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 \[Euro quality of life - 5 Dimensions (EQ-5D)\]Íž 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R092670SCH4033 | OTHER | Janssen-Cilag Ltd. | View |