Schizophrenia Clinical Trial
Official title:
Evaluation of the Functional Remission Occurrence and Predictive Factors in Schizophrenia
Verified date | October 2018 |
Source | Janssen-Cilag Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 364 |
Est. completion date | July 12, 2017 |
Est. primary completion date | June 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 37 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Janssen-Cilag Ltd. |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | Predictive Clinical Characteristics | Search for clinical variables predicting an improvement in social performance. | 1 year Follow up | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05039489 -
A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT05111548 -
Brain Stimulation and Cognitive Training - Efficacy
|
N/A | |
Completed |
NCT05321602 -
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
|
Phase 1 | |
Completed |
NCT04503954 -
Efficacy of Chronic Disease Self-management Program in People With Schizophrenia
|
N/A | |
Completed |
NCT02831231 -
Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium
|
Phase 1 | |
Completed |
NCT05517460 -
The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
|
N/A | |
Completed |
NCT03652974 -
Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy
|
Phase 4 | |
Recruiting |
NCT04012684 -
rTMS on Mismatch Negativity of Schizophrenia
|
N/A | |
Recruiting |
NCT04481217 -
Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT00212784 -
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)
|
Phase 3 | |
Completed |
NCT04092686 -
A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
|
Phase 3 | |
Completed |
NCT01914393 -
Pediatric Open-Label Extension Study
|
Phase 3 | |
Recruiting |
NCT03790345 -
Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics
|
Phase 2/Phase 3 | |
Recruiting |
NCT05956327 -
Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
|
N/A | |
Terminated |
NCT03261817 -
A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders
|
N/A | |
Terminated |
NCT03209778 -
Involuntary Memories Investigation in Schizophrenia
|
N/A | |
Completed |
NCT02905604 -
Magnetic Stimulation of the Brain in Schizophrenia or Depression
|
N/A | |
Recruiting |
NCT05542212 -
Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia
|
N/A | |
Completed |
NCT04411979 -
Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia
|
N/A | |
Terminated |
NCT03220438 -
TMS Enhancement of Visual Plasticity in Schizophrenia
|
N/A |