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Trial record 17 of 3335 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 : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date July 25, 2018
First Posted Date August 14, 2018
Last Update Posted Date October 18, 2019
Actual Study Start Date November 29, 2018
Estimated Primary Completion Date November 14, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 13, 2018)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03629951 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 13, 2018)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study for Schizophrenia Relapse Prediction
Official Title An Observational Study for Schizophrenia Relapse Prediction
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Schizophrenia
Intervention 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.
Study Groups/Cohorts 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.
Intervention: Drug: Oral Antipsychotics (OAP)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 13, 2018)
333
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 14, 2021
Estimated Primary Completion Date November 14, 2021   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com
Listed Location Countries India
Removed Location Countries  
 
Administrative Information
NCT Number NCT03629951
Other Study ID Numbers CR108481
NOPRODSCH4001 ( Other Identifier: Janssen Research & Development, LLC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Janssen Research & Development, LLC
Study Sponsor Janssen Research & Development, LLC
Collaborators Not Provided
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date October 2019