NCT02874560

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
364

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 12, 2014

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 22, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2017

Completed
Last Updated

October 22, 2018

Status Verified

October 1, 2018

Enrollment Period

2.9 years

First QC Date

August 17, 2016

Last Update Submit

October 19, 2018

Conditions

Schizophrenia

Keywords

CNSAntipsychoticFunctional remissionObservational studyFROGSPSPFunctioningSchizophrenia

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Functional Response

    1 year Follow up

  • Satisfactory Level of Functioning

    1 year Follow up

  • Predictive Clinical Characteristics

    1 year Follow up

  • Threshold Score

    1 year Follow up

Study Arms (1)

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).

Eligibility Criteria

Age18 Years - 37 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • Resistant schizophrenia (no response after receiving two successive antipsychotic treatments at an effective dose, each over at least a four-week period)
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Paris, France

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Janssen-Cilag Ltd. Clinical Trial

    Janssen-Cilag Ltd.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2016

First Posted

August 22, 2016

Study Start

August 12, 2014

Primary Completion

June 30, 2017

Study Completion

July 12, 2017

Last Updated

October 22, 2018

Record last verified: 2018-10

Locations

FR(1)