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CTRI Number  CTRI/2025/07/091664 [Registered on: 24/07/2025] Trial Registered Prospectively
Last Modified On: 10/09/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Treatment response among bipolar disorder patients 
Scientific Title of Study   Molecular profiling of A- kinase anchoring protein 11 (AKAP11) and Glycogen synthase kinase - 3 beta (GSK3B) expression and their association with clinical and treatment outcomes among bipolar disorder patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr A Ashvil 
Designation  PhD Research scholar 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences
Paneer, Deralakatte, Mangalore 575018
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9531922466  
Fax    
Email  ashvil1999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shrinivasa Undaru Bhat 
Designation  Professor & Head 
Affiliation  KS Hegde Medical Academy 
Address  Department of Psychiatry, Justice K S Hegde Charitable Hospital
Deralakatte, Mangalore 575018
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9845204136  
Fax    
Email  shrinivasabhat@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Juno J Joel 
Designation  Associate Professor 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences
Paneer, Deralakatte, Mangalore 575018
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9480470727  
Fax    
Email  junojoel@nitte.edu.in  
 
Source of Monetary or Material Support  
Nitte University, 6th Floor, University Enclave, Medical Sciences Complex, Deralakatte, Mangaluru, Karnataka 575018 
 
Primary Sponsor  
Name  Nitte University 
Address  6th Floor, University Enclave, Medical Sciences Complex, Deralakatte, Mangaluru, Karnataka 575018  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr A Ashvil  Justice KS Hegde Hospital  Department of Psychiatry, Justice KS Hegde Charitable Hospital and Central Research Laboratory (CRL) of KS Hegde Medical Academy, Nitte (Deemed to be University), Deralakatte, Karnataka, India. Dakshina Kannada KARNATAKA
Dakshina Kannada
KARNATAKA 		 9531922466

ashvil1999@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Central Ethics Committee, Nitte University  Approved 
Yenepoya Ethics Committee-1  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F319||Bipolar disorder, unspecified. Ayurveda Condition: UNMADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-controlNIL
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. BD patients aged between 18 – 65 years.
2. BD patients or impartial witness willing to participate or provide written informed consent.
3. BD patients presenting with mania / depression / mixed episodes.
4. Newly diagnosed BD patients from the Department of Psychiatry (IPD/OPD patients).

 
 
ExclusionCriteria 
Details  1. K/C/O Alcohol use disorder (AUD) and K/C/O substance use disorder.
2. Another independent psychiatric disorder (dual diagnosis).
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Clinical outcomes: Medication adherence and Functional outcomes
Treatment outcomes: Mood outcomes and Treatment response 		 Baseline, 1 months, 2 months and 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="118"
Sample Size from India="118" 
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)   01/08/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  		 Review article: 01 
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 - Clinical Study Report

  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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ashvil1999@gmail.com].

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   This study will enroll 59 patients with bipolar disorder and 59 First Degree Relatives. The study aims to investigate the expression pattern of AKAP11 and GSK3 beta among bipolar disorder patients and their first-degree relatives using blood or serum samples at two different time points baseline and third month. Additionally, the same patients will be assessed for their clinical and treatment outcomes at baseline and followed up over a period of three consecutive months. The expression levels of both genes will be correlated with clinical and treatment outcomes.  
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