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CTRI Number  CTRI/2017/11/010497 [Registered on: 15/11/2017] Trial Registered Retrospectively
Last Modified On: 11/04/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   A study on depression during and after pregnancy. 
Scientific Title of Study   ANIRVID: Screening for Perinatal Depression Using Point of Care Device, Metabolomics and Conventional Techniques. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sai Sathish Ramamurthy  
Designation  Principal Investigator 
Affiliation  Sri Sathya Sai Institute of Higher Learning 
Address  Department of Chemistry Sri Sathya Sai Institute of Higher Learning Prasanthi Nilayam campus, Puttaparthi, Anantapur District

Anantapur
ANDHRA PRADESH
515134
India 
Phone  8790314405  
Fax    
Email  rsaisathish@sssihl.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sai Sathish Ramamurthy  
Designation  Principal Investigator 
Affiliation  Sri Sathya Sai Institute of Higher Learning 
Address  Department of Chemistry Sri Sathya Sai Institute of Higher Learning Prasanthi Nilayam campus, Puttaparthi, Anantapur District

Anantapur
ANDHRA PRADESH
515134
India 
Phone  8790314405  
Fax    
Email  rsaisathish@sssihl.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Sai Sathish Ramamurthy  
Designation  Principal Investigator 
Affiliation  Sri Sathya Sai Institute of Higher Learning 
Address  Department of Chemistry Sri Sathya Sai Institute of Higher Learning Prasanthi Nilayam campus, Puttaparthi, Anantapur District

Anantapur
ANDHRA PRADESH
515134
India 
Phone  8790314405  
Fax    
Email  rsaisathish@sssihl.edu.in  
 
Source of Monetary or Material Support  
Tata Education and Development Trust c/o. Sri Ratan Tata Trust, Bombay House, Homi Mody Street, Fort, Mumbai 400001 Tel. No. 022-6665 8282 Fax: 022-6665 8013 
 
Primary Sponsor  
Name  Tata Education and Development Trust 
Address  c/o. Sri Ratan Tata Trust, Bombay House, Homi Mody Street, Fort, Mumbai 400001 
Type of Sponsor  Other [Private Funding Agency] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajani Upadhyaya  Sri Sathya Sai General Hospital  Room No. 6, Ground Floor, Department of Obstetrics and Gynaecology, Prasanthi Nilayam, Puttaparthi-515134
Anantapur
ANDHRA PRADESH 		 9676445951

rajaniu89@gmail.com 
Dr Akkamahadevi C Hiremath  Sri Sathya Sai General Hospital, Sri Sathya Sai Institute of Higher Medical Sciences  Room No. G918, Ground Floor, Department of Obstetrics and Gynaecology, EPIP Area, Whitefield, Bangalore-560066
Bangalore
KARNATAKA 		 9448434567

akkuch@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee of Sri Sathya Sai Institute of Higher Medical Sciences  Approved 
Institutional Ethics Committee of Sri Sathya Sai Institute of Higher Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Pregnant women who are between 18 to 40 years age are considered for this study. For baseline samples, non-pregnant women will also be considered.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Pregnant Women inclusion criteria: 18 to 40 years of age

Non-pregnant women inclusion criteria (for baseline samples): 18 to 40 years of age 
 
ExclusionCriteria 
Details  Pregnant women exclusion criteria: those who are already on psychotropic medication.

Non-pregnant women exclusion criteria (for baseline samples): those who are already on psychotropic medication and those who have a baby of less than 2 years old.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To monitor depression in pregnant women using point-of-care device.

Achieve biomarker validation / discovery with the use of metabolomics. 		 Samples from the pregant women are collected twice before the delivery (one between 24-28 weeks and one during 36-38 weeks of gestational period) and four times after deliver, i.e., 1st day, 7th day, 14th day and 3 months after delivery.

The baseline sample collection from the non-pregnant women participants will be taken only once. 
 
Secondary Outcome  
Outcome  TimePoints 
Facilitate the early diagnosis and management of depression in pregnant women and mothers.
 		 3 years 
 
Target Sample Size   Total Sample Size="600"
Sample Size from India="600" 
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)   05/10/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  		 Perinatal depression is highly prevalent and is an important public health problem as it affects both the mother and the newborn baby. Early detection of perinatal depression is hence necessary for the benefit of both mother and child in the society. The main goal of this multi-center study is to develop a rapid, hand-held, mobile-health point-of-care diagnostic device, for monitoring key biomarkers related to depression in pregnant women (both during pregnancy and postnatal periods) at low-cost than current existing systems. We will achieve biomarker validation (leading to biomarker discovery) in this study with the use of metabolomics. In addition to the development and validation of this indigenously developed device on the concerned patient population, the proposed study will facilitate early diagnosis, prognosis and modification in the management of depression for the benefit of pregnant women and mothers in the society. 
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