| CTRI Number |
CTRI/2024/03/064449 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
13/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Research on Psychoses in Diverse Settings : Deepening and Broadening Knowledge |
|
Scientific Title of Study
|
INTREPID - Deepening and Broadening knowledge of Psychoses Globally |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SRF-CR/05/Sep 2023, Version 2.0 dated 28 Nov 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Thara Rangaswamy |
| Designation |
Vice Chairman |
| Affiliation |
Schizophrenia Research Foundation, India |
| Address |
R/7a North Main Road, Anna
Nagar West
Extension, Chennai, Tamil Nadu
Chennai TAMIL NADU 600101 India |
| Phone |
9840238870 |
| Fax |
|
| Email |
thara@scarfindia.org |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Thara Rangaswamy |
| Designation |
Vice Chairman |
| Affiliation |
Schizophrenia Research Foundation, India |
| Address |
R/7a North Main Road, Anna
Nagar West
Extension, Chennai, Tamil Nadu
TAMIL NADU 600101 India |
| Phone |
9840238870 |
| Fax |
|
| Email |
thara@scarfindia.org |
|
Details of Contact Person Public Query
|
| Name |
Dr Thara Rangaswamy |
| Designation |
Vice Chairman |
| Affiliation |
Schizophrenia Research Foundation, India |
| Address |
R/7a North Main Road, Anna
Nagar West
Extension, Chennai, Tamil Nadu
TAMIL NADU 600101 India |
| Phone |
9840238870 |
| Fax |
|
| Email |
thara@scarfindia.org |
|
|
Source of Monetary or Material Support
|
| Medical Research Council, UK |
|
|
Primary Sponsor
|
| Name |
Medical Research Council |
| Address |
Medical Research Council (MRC)
Polaris House,
North Star Avenue,
Swindon,
SN2 1FL
|
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India Nigeria Trinidad and Tobago |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Thara Rangaswamy |
Schizophrenia Research Foundation, India |
Room no. 24, Department of Research, R7a North Main Road, Anna
Nagar West
Extension, Chennai, Tamil Nadu, 600101
Chennai TAMIL NADU |
9840238870
thara@scarfindia.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of SCARF (I) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F200||Paranoid schizophrenia, (2) ICD-10 Condition: F201||Disorganized schizophrenia, (3) ICD-10 Condition: F202||Catatonic schizophrenia, (4) ICD-10 Condition: F203||Undifferentiated schizophrenia, (5) ICD-10 Condition: F205||Residual schizophrenia, (6) ICD-10 Condition: F205||Residual schizophrenia, (7) ICD-10 Condition: F208||Other schizophrenia, (8) ICD-10 Condition: F209||Schizophrenia, unspecified, (9) ICD-10 Condition: F22||Delusional disorders, (10) ICD-10 Condition: F21||Schizotypal disorder, (11) ICD-10 Condition: F23||Brief psychotic disorder, (12) ICD-10 Condition: F24||Shared psychotic disorder, (13) ICD-10 Condition: F28||Other psychotic disorder not due to a substance or known physiological condition, (14) ICD-10 Condition: F29||Unspecified psychosis not due to asubstance or known physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria for people with psychosis (“casesâ€):
1. Age 18 to 64 years at the start of the case-finding period
2. Currently resident in catchment area (primary residence)
3. Presence of ICD-11 psychotic disorder, including substance-induced psychoses.
4. Not treated with antipsychotic medication for more than one continuous month
prior to the start of initial case identification
Inclusion criteria for relatives:
1. Age 18 and above
2. Relative of an individual with a psychotic disorder who has consented to participate in the current study (either first-degree relative or other family member involved in care of the participating individual)
Inclusion criteria for controls:
1. Age 18 to 64 years
2. Resident in catchment area (primary residence)
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria for people with psychosis (“casesâ€):
1. Transient psychotic symptoms resulting from acute intoxication as defined by ICD-
11
2. Moderate or severe learning disability, as defined by ICD-11
3. Clinically manifest organic cerebral disorder (e.g. infections, parasitic, toxic,
cerebrovascular, epilepsy, brain injury), as defined by ICD-11
Exclusion criteria for relatives:
1. Insufficient contact with case to provide information on family burden or
psychiatric history
Exclusion criteria for controls:
1. Past or current ICD-10 psychotic disorder
2. Transient psychotic symptoms due to acute intoxication as defined by ICD-11
3. Moderate or severe learning disability, as defined by ICD-11
4. Clinically manifest organic cerebral disorder (e.g. infections, parasitic, toxic,
cerebrovascular, epilepsy, brain injury), as defined by ICD-11
5. Related to the matched case |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Predictors of medium term course and outcome of psychoses; psychopathology; living situations; physical health; interpersonal relationships
Stress Sensitivity; Mood and Behaviour
Cognitive Functioning
Accelerated Aging
|
2 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pathways to homelessness; Help-seeking behaviour |
2 year |
|
|
Target Sample Size
|
Total Sample Size="1441" Sample Size from India="480"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/06/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [thara@scarfindia.org].
- For how long will this data be available start date provided 01-06-2028 and end date provided 01-06-2033?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
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Brief Summary
|
INTREPID is a programme on the epidemiology of Psychoses in three sites in the Global South (India, Nigeria, Trinidad). With INTREPID, our ultimate, ambitious goal is to transform our knowledge of and responses to psychotic disorders globally. We plan to achieve this by (1) delivering novel research programmes on medium-term course and outcomes, homeless populations, and putative mechanisms of risk and relapse, and (2) implementing a structured set of activities in each setting to ensure findings inform the development, and ultimately testing, of bespoke interventions. Our programme will be guided by our lived experience teams in each setting. We wish to examine the underlying mechanisms and processes involved in varying presentations, higher rates, poorer outcomes, and patterns of physical health and mortality. Three putative mechanisms are of particular interest that may mediate and constitute the pathways between risks and the onset and outcome of psychoses: (1) stress sensitivity; (2) cognitive function; and (3) accelerated aging. We have fixed the cohort sample size in each site to be between 200 and 220. And an additional 20 cases and 20 controls experiencing homelessness will be recruited to help us identify the pathways to homelessness. Quantitative research method is used to understand how the course of psychoses and other outcomes differ between the sites. Qualitative research method is used to examine the profiles and needs of individuals with a psychotic disorder who are homeless and to examine pathways into homelessness in each setting. Appropriate statistical analysis methods will be used to analyse the collected data. The overall outcomes are the predictors of course of psychoses and how it affects living situations, interpersonal relationships, physical health, cognitive functioning, etc. with this study we expect to deepen and broaden our understandings of psychotic disorders and to inform the development of locally relevant humane, accessible, and effective services.
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