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Trial record 17 of 3313 for:    schizophrenia

A Study for Schizophrenia Relapse Prediction

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ClinicalTrials.gov Identifier: NCT03629951
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
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.

Condition or disease Intervention/treatment
Schizophrenia Drug: Oral Antipsychotics (OAP)

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Study Type : Observational
Estimated Enrollment : 333 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study for Schizophrenia Relapse Prediction
Actual Study Start Date : November 29, 2018
Estimated Primary Completion Date : November 14, 2021
Estimated Study Completion Date : November 14, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Group/Cohort Intervention/treatment
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.
Drug: 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.




Primary Outcome Measures :
  1. Number of Participants with Relapse [ Time Frame: Up to Approximately 3 years ]
    Relapse is defined as achieving any of the following: clinically meaningful worsening of symptoms as determined by the treating physician's judgment; involuntary or voluntary admission to a psychiatric hospital for decompensation of the participant's schizophrenic symptoms (psychiatric hospitalization); deliberate self‐injury and/or violent behavior resulting in clinically significant injury to the participant or another person or property damage; suicidal or homicidal ideation and aggressive behavior considered as clinically significant (in frequency and severity) in the treating physician's judgment; an increase of at least 2 points from the lowest reported Clinical Global Impression-Severity (CGI-S) score (ranging from 1 [not ill] to 7 [extremely severe]) captured either at baseline or post baseline. Number of participants with relapse will be determined.


Secondary Outcome Measures :
  1. Number of Participants in each Clinical State of Schizophrenia [ Time Frame: Up to approximately 3 years ]
    Number of participants in each clinical state (Acute, Stable, and Remission) of schizophrenia will be assessed. The clinical states are defined as: 'Acute' - Clinical Global Impression-Severity (CGI‐S) score (ranging from 1 [not ill] to 7 [extremely severe]) greater than or equal to (>=)5 anytime during the study; 'Stable' (Tier I) - control of acute symptoms, defined as having a CGI‐S score of less than or equal to (<=)3 for a minimum of 3 months and/or (Tier II) - stable dosage of oral antipsychotic (OAPs) for a minimum of 3 months and control of acute symptoms, defined as having a CGI‐S score of <=4 for a minimum of 3 months; and 'Remission' - a continuous CGI-S scale score of <=2 for 6 months.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with clinical diagnosis of schizophrenia receiving an oral antipsychotic (OAP) treatment regimen directed by their treating clinician will be observed.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03629951


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
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India
Panchshil Hospital Recruiting
Ahmedabad, India, 380005
Ratandeep Multispeciality Hospital Recruiting
Ahmedabad, India, 380008
M S Ramaiah Medical College and Hospital Withdrawn
Bangalore, India, 560054
Asha hospital Recruiting
Hyderabad, India, 500034
Mahendru Psychiatric Centre Recruiting
Kanpur, India, 208005
Ahana Hospitals Not yet recruiting
Madurai, India, 625020
Kasturba Medical College Hospital Recruiting
Manipal, India, 576104
Meera Hospital Recruiting
Mumbai, India, 421301
Meditrina Institute of Medical Sciences Recruiting
Nagpur, India, 440010
GMERS Medical College and Hospital Recruiting
Vadodara, India, 390021
Deva Institute of Health Care and Research Pvt Ltd Recruiting
Varanasi, India, 221005
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Additional Information:
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03629951     History of Changes
Other Study ID Numbers: CR108481
NOPRODSCH4001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs