A Study for Schizophrenia Relapse Prediction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

333 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-29

Study Completion Date

2021-12-31

Brief Summary

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The purpose of this study is to identify if there are self-reported/caregiver reported or objective measures that can predict near-term relapse (within 1 month or at another identified time point before meeting the criteria for relapse) or early symptomatic changes indicative of pre-relapse.

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Detailed Description

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Conditions

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Schizophrenia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with Schizophrenia

Participants will not receive any intervention as a part of this study. Participants with a diagnosis of schizophrenia or schizoaffective disorder receiving oral antipsychotics (OAP) for example, risperidone (1 to 6 milligram \[mg\] once daily \[OD\] to twice a day \[BID\]), olanzapine (5 to 20 mg OD), haloperidol (5 to 20 mg OD to thrice a day \[TID\]) etc, per their treating physician/clinician instruction will be observed. The primary data source for this study will be the clinical assessments by the treating physician of each participant conducted as a part of routine clinical practice.

Oral Antipsychotics (OAP)

Intervention Type DRUG

This is an observational study. Participants enrolled in this study will continue to receive routine treatment of OAPs for example, risperidone (1 to 6 mg OD to BID), olanzapine (5 to 20 mg OD), haloperidol (5 to 20 mg OD to TID) etc, as directed by their treating physician.

Interventions

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Oral Antipsychotics (OAP)

This is an observational study. Participants enrolled in this study will continue to receive routine treatment of OAPs for example, risperidone (1 to 6 mg OD to BID), olanzapine (5 to 20 mg OD), haloperidol (5 to 20 mg OD to TID) etc, as directed by their treating physician.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants and their legally acceptable representative where applicable must be able to sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is willing to participate for the duration of the study
* Have a clinical diagnosis of schizophrenia made by a clinician with understanding of the criteria for schizophrenia or schizoaffective disorder, per the Diagnostic and Statistical Manual of Mental Disorders - 5th edition (DSM-5), and had at least 1 relapse, in the opinion of the investigator, within the last 12 months prior to date of informed consent
* Must be receiving an OAP treatment regimen at the time of enrollment
* Must be able to speak, read, and understand English and/or the local Indian language as the patient reported outcome instruments will be validated in regional languages
* Caregivers/Informants should be able to sign an ICF indicating that he or she understands the purpose of and procedures required for the study and is willing to participate for the duration of the study

Exclusion Criteria

* Has treatment resistant schizophrenia (that is, currently receiving clozapine or electroconvulsive therapy \[ECT\])
* Is on long-acting injectable antipsychotic regimen at the time of screening
* Has a moderate to severe substance use disorder (other than nicotine), as determined by the investigator
* Has a significant risk of suicide or active suicidality with a plan as indicated by the Columbia-Suicide Severity Rating Scale (C-SSRS) assessment
* Has an immediate need for hospitalization (that is, the participant is already in a relapse)

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No