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CTRI Number  CTRI/2025/06/089110 [Registered on: 19/06/2025] Trial Registered Prospectively
Last Modified On: 18/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Changes in serum uric acid during natural course of mania (baseline to 10 weeks) with usual care in patients with bipolar-I disorder  
Scientific Title of Study   Assessment of serum uric acid and its association with short-term naturalistic course of manic episode in patients with bipolar I disorder 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priyanka 
Designation  Junior Resident 
Affiliation  AIIMS, New Delhi 
Address  Department of Psychiatry, All India Institute of Medical Sciences, New Delhi

South
DELHI
11029
India 
Phone  8168477490  
Fax    
Email  priyanka13437@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Raman Deep 
Designation  Professor 
Affiliation  AIIMS, New Delhi 
Address  Department of Psychiatry, All India Institute of Medical Sciences, New Delhi

South
DELHI
110029
India 
Phone  26588500  
Fax    
Email  drramandeep@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Raman Deep 
Designation  Professor 
Affiliation  AIIMS, New Delhi 
Address  Department of Psychiatry, All India Institute of Medical Sciences, New Delhi

South
DELHI
110029
India 
Phone  26588500  
Fax    
Email  drramandeep@gmail.com  
 
Source of Monetary or Material Support  
Department of Psychiatry, All India Institute of Medical Sciences (AIIMS) Delhi, Ansari Nagar, New Delhi-110029, India 
 
Primary Sponsor  
Name  AIIMS NEW DELHI 
Address  The study is a part of MD thesis in the Department of Psychiatry,All India Institute of Medical Sciences, New Delhi 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Priyanka Singh  All India Institute of Medical Sciences, New Delhi  Room-4096, 4th Floor, Academic Block, Department of Psychiatry
South West
DELHI 		 8168477490

priyanka13437@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for Post Graduate Research, All India Institute of Medical Sciences, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthy controls, with no history of any psychiatric disorder  
Patients  (1) ICD-10 Condition: F311||Bipolar disorder, current episodemanic without psychotic features,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Inclusion criteria for cases 18 to 45 years and Meeting DSM 5 criteria for Bipolar 1 disorder current episode mania. Inclusion criteria for Controls comprise 18 to 45 years, and screen negative using PHQ-9 and GAD- 
 
ExclusionCriteria 
Details  Exclusion criteria for Cases:
1. Any co occurring psychiatric illness or
intellectual disability( as per known
history)
2. Any current use of substance apart
from nicotine ( as per known history)
3. Any known medical condition that has
the potential to interfere with the the
study assessments
4. Pregnancy or lactation
5. ECT in past 1 month
Exclusion criteria for Controls:
1. GAD score>10 or PHQ-9 score>10
2. Any psychiatric illness or intellectual
disability( as per known history)
3. Any current use of substance apart
from nicotine ( as per known history)
4. Any known medical condition that has
the potential to interfere with the the
study assessments
5. Pregnancy or lactation 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) Assess and compare the serum uric acid across manic patients and matched
healthy controls 2)Assess the clinical profile, including symptom severity and its association with
serum uric acid in patients with mania at baseline and prospective follow-up 		 Baseline, followed by 3 time points in next 10 weeks , that is week 2,4, and 10. Completers will be any 2 time points including baseline  
 
Secondary Outcome  
Outcome  TimePoints 
Assess the clinical profile, including symptom severity and its association with
serum uric acid in patients with mania at baseline and prospective follow-up 		 Baseline, followed by 3 time points in next 10 weeks , that is week 2,4, and 10. Completers will be any 2 time points including baseline  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   30/06/2025 
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="1"
Months="6"
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 - NO
Brief Summary  
Worldwide, there is a high prevalence of
bipolar disorder(BD) and is a 6th leading
cause of disability in psychiatric patients. As
of now there is no identifiable biomarker
available for BD. Past studies have shown
some correlation with serum Uric Acid(UA)
however there is less evidence in the form of
prospective studies and only one study in the
Indian context and serum uric acid is an easily
measurable biomarker.   As per predefined aims and objectives (stated above), and selection criteria (aforementioned), Out of the referred
patients, those with YMRSscore >12 will be chosen by a purposive method for
participation in the study. Healthy controls will be selected from attendants and non
biological relatives accompanying the patients. Diagnosis of BD-1 current episode mania will be confirmed using DSM-5 criteria by clinical interview and subjects fulfilling
the inclusion and exclusion criteria will be recruited. Subjects will be screened for
psychiatric comorbidities using clinical interviews. Physical, neurological and substance
use comorbidity as well as pregnancy/lactation will be ruled out by history and clinical
examination. Written consent will be taken prior to participation in the study.
Baseline assessments would be done. Sociodemographic and Clinical data
(Semi-structured datasheet) would be recorded. Questionnaires (PHQ-9 and GAD-7
screening) would be applied and 5 ml blood would be drawn (for Serum uric acid,
KFT,LFT,TSH,FBS,Total cholestrol estimation) would be done for the control group.
For the case group, sociodemographic, clinical data(semi structured datasheet) along
with the assessment scales including YMRS, CGI-BP, BVC-6 item, GAF,IPQ-SF would be
applied. 5 ml blood would be drawn (for Serum uric acid, KFT,LFT,TSH,FBS,Total
cholestrol estimation).
The cases will be followed up for 10 weeks that include 3 time points that is 2 weeks±
4 days, 4 weeks ±1 week and 10 week ±2 weeks .at every follow up clinical proforma,
assessment scales( YMRS,CGI-BP,GAF IPAQ-SF) would be applied along with 2 ml
fasting blood sample for serum uric estimation. Completers would be the patients who
followed up at once after the baseline assessment.
 
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