| CTRI Number |
CTRI/2025/12/099455 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Neuromodulation using rTMS ] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Improving Apathy and Motivation in Schizophrenia Using a Novel Brain-Stimulation Method |
|
Scientific Title of Study
|
Role Of Adjunctive Intermittent Theta Burst Stimulation Over Left Dorsolateral Prefrontal Cortex In Patients With Negative Symptoms Of Schizophrenia: A Randomized Double-Blind Sham Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gourab Bhattacharya |
| Designation |
Post Graduate Trainee |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
Department of Psychiatry, Institute of Psychiatry, IPGMER and SSKM Hospital, Kolkata
Kolkata
WEST BENGAL
700025
India |
| Phone |
8250888164 |
| Fax |
|
| Email |
gourab.bhatt.gb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sujit Sarkhel |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of Psychiatry, Institute of Psychiatry, IPGMER and SSKM hospital, Kolkata
Kolkata
WEST BENGAL
700025
India |
| Phone |
9836074700 |
| Fax |
|
| Email |
sujitsarkhel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gourab Bhattacharya |
| Designation |
Post Graduate Trainee |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
Department of Psychiatry, Institute of Psychiatry, IPGMER and SSKM hospital, Kolkata
Kolkata
WEST BENGAL
700025
India |
| Phone |
8250888164 |
| Fax |
|
| Email |
gourab.bhatt.gb@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
IPGMER and SSKM Hospital |
| Address |
Institute of Psychiatry, 7, Debendra Lal Khan Rd, Alipur, Bhowanipore, Kolkata, West Bengal 700025 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Gourab Bhattacharya |
Institute of Psychiatry, IPGMER and SSKM Hospital |
Department of Psychiatry, Institute of Psychiatry, IPGMER and SSKM Hospital Kolkata, West Bengal 700025
Kolkata
WEST BENGAL |
8250888164
gourab.bhatt.gb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R Research Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F200||Paranoid schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intermittent Theta Burst Stimulation, a form of repetitive transcranial magnetic stimulation |
a) Stimulus intensity: 80% of Resting MT.
b) Burst Frequency in train: 5 Hz
c) Pulse Frequency in Burst: 50 Hz
d) Bursts in trains: 10
e) Number of Pulses in Bursts: 03
f) Number of Trains: 20
g) Inter train interval : 8s
h) Total Number of Pulses per session: 600 pulses therefore a total of 12000 pulses.
i) Total number of Sessions: 20 sessions
j) Total Duration: 3minutes 32seconds for one session, and two such sessions for 5 days a week for 2 weeks that is 10 days, so 20 sessions in 10 days
|
| Comparator Agent |
Sham stimulation |
During sham intervention , the coil was tilted 90 degrees relative to the position during active intervention . Total duration of intervention being the same- 5 days a week for 2 weeks that is 10 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age between 18-65 years.
Subjects meeting SCID-5-CV criteria which generates DSM 5 diagnosis for Schizophrenia and having at least 20 score on PANSS negative subscore scale with at least two items more than equal to 4, without showing a more than 20 percent response between pre-inclusion and inclusion visit.
On antipsychotic medications at effective dosages for more than six weeks.
|
|
| ExclusionCriteria |
| Details |
i. Current SCID-5-CV criteria which generates as per DSM 5- diagnosis of Severe depressive disorder, suicidal ideations, or any other psychotic disorder, or any other severe comorbid psychiatric illness, or substance use disorder.
ii. Standard rTMS contraindications like history of epilepsy, metal implants near the head in any part of the body, history of neurosurgical operations , pacemaker implant, evaluated using TMS adult safety screen (TASS) questionnaire.
iii. Concurrent use of medications or drugs that are known to reduce the seizure threshold.
iv. Acute or chronic debilitating physical illness.
v. Pregnancy or lactation.
vi. Subjects with intellectual disabilities.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE AND ASCERTAIN THE ROLE OF ADJUNCTIVE INTERMITTENT THETA BURST STIMULATION OVER LEFT DORSOLATERAL PREFRONTAL CORTEX IN PATIENTS WITH NEGATIVE SYMPTOMS OF SCHIZOPHRENIA |
baseline and 7,14,28 and 60 days from the end of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to ascertain whether itbs is a safe & well tolerated regimen for patients with schizophrenia |
baseline & 7,14,28 & 60 days from the end of intervention |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
29/12/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| 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
|
Our study provides evidence that left DLPFC stimulation can significantly reduce negative symptoms in schizophrenia, with statistically significant results. The results reinforce the role of neuromodulation as an adjunctive treatment in schziophrenia and highlight the need for further research to optimise stimulation parameters and patient selection criteria. These findings contribute to the growing body of literature supporting non- invasive brain stimulation techniques in psychiatric disorders and underscore the need for continued exploration of individualised neuromodulation strategies in schizophrenia treatment. |