SchizophreniaNCT03629951
A Study for Schizophrenia Relapse Prediction
An observational study of Schizophrenia, run by Janssen Research & Development, LLC at 10 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Oral Antipsychotics (OAP)
- Type of treatment
- Pill or oral medicine
- How many people
- 333 participants
- Where
- 10 sitesIndia
- Study dates
- 29 Nov 2018to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Participants with clinical diagnosis of schizophrenia receiving an oral antipsychotic (OAP) treatment regimen directed by their treating clinician will be observed.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
India10 sites
Panchshil Hospital
Ahmedabad, 380005
Ratandeep Multispeciality Hospital
Ahmedabad, 380008
Asha hospital
Hyderabad, 500034
Mahendru Psychiatric Centre
Kanpur, 208005
Ahana Hospitals
Madurai, 625020
Kasturba Medical College Hospital
Manipal, 576104
Meera Hospital
Mumbai, 421301
Meditrina Institute of Medical Sciences
Nagpur, 440010
GMERS Medical College and Hospital
Vadodara, 390021
Deva Institute of Health Care and Research Pvt Ltd
Varanasi, 221005
About this study
Official title: An Observational Study for Schizophrenia Relapse Prediction
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.
- Conditions
- Schizophrenia
- Being tested
- Oral Antipsychotics (OAP)
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Antipsychotics (OAP)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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Oral Antipsychotics (OAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Relapse
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.
Measured: Up to Approximately 3 years
Secondary outcomes (1)
Number of Participants in each Clinical State of Schizophrenia
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.
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start29 Nov 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629951
- Sponsor's protocol ID
- CR108481
- Other IDs
- NOPRODSCH4001
- Status last verified
- Apr 2025
- First submitted
- 25 Jul 2018
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study for Schizophrenia Relapse Prediction
- ClinicalTrials.gov ID
- NCT03629951
- Acronym / sponsor ID
- CR108481
- Conditions
- Schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Schizophrenia | – | Drug: Oral Antipsychotics (OAP)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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants with clinical diagnosis of schizophrenia receiving an oral antipsychotic (OAP) treatment regimen directed by their treating clinician will be observed.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Participants with Schizophrenia |
Primary outcome
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.
1 secondary outcome
Number of Participants in each Clinical State of Schizophrenia
Time frame: Up to approximately 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Janssen Research & Development, LLC at 10 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Relapse (time frame: Up to Approximately 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.