FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  64.00 Year(s)
Gender  Both 
Details  Inclusion criteria for people with psychosis (“cases”):
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 (“cases”):
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. 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.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [thara@scarfindia.org].

  6. 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.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
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.


 
Close