| CTRI Number |
CTRI/2026/01/100037 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
24/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Association Between Sodium Channel Gene Variations and Valproate Treatment Response in Bipolar Disorder A Longitudinal Study at a Tertiary Care Hospital |
|
Scientific Title of Study
|
Association of sodium channel Single Nucleotide Polymorphism (SNP) with valproate response among bipolar disorder patients in a tertiary care hospital A Longitudinal study. |
| 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 ASWINYP |
| Designation |
Postgraduate resident |
| Affiliation |
Indira Gandhi Medical College and Research Institute |
| Address |
Department of Pharmacology, Indira Gandhi Medical
College and Research Institute, Puducherry
Pondicherry
PONDICHERRY
605009
India |
| Phone |
9600644230 |
| Fax |
|
| Email |
aswiny14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maharani B |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Medical College and Research Institute |
| Address |
Department of Pharmacology, Indira Gandhi Medical
College and Research Institute, Puducherry
Pondicherry
PONDICHERRY
605009
India |
| Phone |
9894344585 |
| Fax |
|
| Email |
drkarthikrani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ASWINYP |
| Designation |
Postgraduate resident |
| Affiliation |
Indira Gandhi Medical College and Research Institute |
| Address |
Department of Pharmacology, Indira Gandhi Medical College and Research Institute, Puducherry
Pondicherry
PONDICHERRY
605009
India |
| Phone |
09600644230 |
| Fax |
|
| Email |
aswiny14@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Aswiny P |
| Address |
Department of Pharmacology IGMCRI, Kathirkamam, Puducherry- 605009 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR ASWINYP |
Indira Gandhi Medical College and Research Institute,Kathirkamam, Puducherry |
4, Department of Psychiatry, MIcrobiology and Pharmacology
Pondicherry
PONDICHERRY |
9600644230
aswiny14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indira gandhi medical college and research institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F316||Bipolar disorder, current episodemixed, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who were prescribed with Sodium Valproate (VPA) for BPAD after initial stabilization with normal LFT. |
|
| ExclusionCriteria |
| Details |
Hyperthyroidism,H/o Suicidal ideation Schizophrenic patients, Schizo-affective disorders or delusional disorders,Contraindications to VPA
Mood disorder due to general medical condition (recent stroke, HIV infection,
unstable medical condition)
Substance abuse, Pregnant and Breastfeeding women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the association of SNP of sodium channel genes with therapeutic response to
Valproate in bipolar disorder patients |
Baseline, 2nd week, 4th week and 6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a.To find out the percentage of responders and non-responders having SCN1A
polymorphism by RFLP (Restriction Fragment Length Polymorphism).
b. To assess the Medication Adherence among the bipolar disorder patients to the
prescribed drugs
c. To evaluate the percentage of bipolar disorder patients who are not responding to
valproate.
d. To assess the safety profile of Valproate when administered to bipolar disorder
patients. |
Baseline, 2nd week, 4th week and 6th week |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
18/01/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a longitudinal pharmacogenomic study aimed at evaluating the association between sodium channel gene single nucleotide polymorphisms (SNPs) and therapeutic response to valproate in patients with bipolar disorder from a South Indian population. Adult patients (18–60 years) diagnosed with bipolar disorder and prescribed sodium valproate will be enrolled and followed for 6 weeks. Treatment response will be assessed using Young Mania Rating Scale (YMRS) and Hamilton Depression Rating Scale (HDRS), and patients will be classified as responders or non-responders. Genotyping of SCN1A SNP (rs2298771) will be performed using PCR–RFLP technique. Secondary outcomes include medication adherence, safety profile, and proportion of non-responders. A total sample size of 96 participants will be included. Data will be analyzed using appropriate statistical tests to determine genetic association, with the aim of supporting personalized valproate therapy in bipolar disorder. |