NCT02712463

Brief Summary

The primary purpose of the study is to compare the rate of hospitalization associated with psychotic relapse in participants with schizophrenia treated one year before with oral antipsychotics and one year after with long acting injectable atypical antipsychotics.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
310

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Shorter than P25 for all trials

Geographic Reach
2 countries

11 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2016

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 24, 2016

Status Verified

May 1, 2016

Enrollment Period

9 months

First QC Date

March 15, 2016

Last Update Submit

May 23, 2016

Conditions

Schizophrenia

Keywords

SchizophreniaOral antipsychoticsLong acting Injectable antipsychotics

Outcome Measures

Primary Outcomes (2)

  • Percentage of Participants with Hospitalizations in 12 Months Before Initial Long Acting Injectable anti-psychotics (LAI) use

    Percentage of participants with hospitalizations due to Psychotic relapse of schizophrenia will be reported.

    12 months before initial LAI use

  • Percentage of Participants with Hospitalizations in 12 Months After Initial Long Acting Injectable anti-psychotics (LAI) use

    12 months after initial LAI use

Secondary Outcomes (2)

  • Number of hospitalizations due to Psychotic Relapse of Schizophrenia

    approximately 2 years

  • Number of Days of Hospitalization due to Psychotic Relapse of Schizophrenia

    approximately 2 years

Study Arms (1)

Participants with Schizophrenia

This is an observational study. Data will be collected from the medical records of participants diagnosed with schizophrenia and who had been on oral antipsychotics for at least one year and thereafter have been switched to Long Acting Injectable atypical antipsychotics for at least one year.

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Participants (both gender and 18 to 55 years of age) with schizophrenia treated with oral anti-psychotics then switched to long acting Injectable anti-psychotics.

You may qualify if:

  • Out-Patients with the main diagnosis of schizophrenia with Diagnostic and Statistical Manual of Mental Disorders (DSM-4 criteria)
  • Only clinical records with complete information during the 2 years period selected for data analysis will be included
  • Participants treated with oral antipsychotics then switched to Long Acting Injectable (LAI) due to poor adherence, lack of efficacy (no significant symptom reduction, judged by physician, at maximum recommended dose of an antipsychotic for 6 weeks), or participants choice, (Excluding for the Brazil population, when the switch has not been clearly justified or the switch has not been done during hospitalization)
  • Being regularly treated with LAI atypical antipsychotics for at least 1 year after the initial use of LAI atypical antipsychotics

You may not qualify if:

  • Participants with refractory schizophrenia (RS)
  • Participants that started LAI treatment as in-patients and patients that switched to LAI during hospitalization (only for Mexican population).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Aracaju, Brazil

Location

Unknown Facility

Brasília, Brazil

Location

Unknown Facility

Rio de Janeiro, Brazil

Location

Unknown Facility

São José, Brazil

Location

Unknown Facility

São Paulo, Brazil

Location

Unknown Facility

Durango, Mexico

Location

Unknown Facility

Hermosillo, Mexico

Location

Unknown Facility

Ixtapaluca, Mexico

Location

Unknown Facility

México, Mexico

Location

Unknown Facility

Monterrey, Mexico

Location

Unknown Facility

San Pedro Garza García, Mexico

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
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2016

First Posted

March 18, 2016

Study Start

July 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

May 24, 2016

Record last verified: 2016-05

Locations

BR(5)ME(6)