| CTRI Number |
CTRI/2026/03/105595 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
07/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study of Accelerated Intermittent Theta Burst Stimulation (aiTBS) for Negative Symptoms in patients with Schizophrenia |
|
Scientific Title of Study
|
Efficacy and Safety of Accelerated Intermittent Theta Burst Stimulation (aiTBS) for Negative Symptoms of Schizophrenia: A Randomised 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 |
Dr Godi Sangha Mitra |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Department of Psychiatry, AIIMS Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
09492414295 |
| Fax |
|
| Email |
mitratriam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Godi Sangha Mitra |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Department of Psychiatry, AIIMS Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
09492414295 |
| Fax |
|
| Email |
mitratriam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Godi Sangha Mitra |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Mangalagiri |
| Address |
Department of Psychiatry, AIIMS Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
09492414295 |
| Fax |
|
| Email |
mitratriam@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Mangalagiri |
| Address |
Dept of Psychiatry, AIIMS Mangalagiri, Guntur, Andhra Pradesh, India, 522503 |
| 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 |
| Dr Godi Sangha Mitra |
AIIMS Mangalagiri |
Department of Psychiatry, AIIMS Mangalagiri, Guntur, India, 522503
Guntur
ANDHRA PRADESH |
09492414295
mitratriam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS Mangalagiri |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F20||Schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Accelerated iTBS |
Active intervention includes accelerated intermittent theta burst stimulation (aiTBS) over the left dorsolateral prefrontal cortex (DLPFC),1800 pulses per session over 10 minutes, 4 sessions per day for duration of 5 consecutive days (20 sessions total) at 80% resting motor threshold (RMT)with an inter-session interval of at least 50 minutes using a figure of 8 coil (Magstim Rapid)
|
| Comparator Agent |
Sham |
TMS will be carried out with the same coil tilted 90° perpendicular to the skull, pulses delivered at low intensity (10% RMT) to elicit similar stimulation.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Chronic schizophrenia patients with a duration of illness of more than 2 years
2. PANSS Negative symptom score more than 15
3. Calgary depression scale for schizophrenia score less than 7
4. On stable doses of antipsychotic medications |
|
| ExclusionCriteria |
| Details |
1. Neurological disorders, substance dependence (except tobacco)
2. Contraindications for RTMS (pacemakers, metallic implants in brain, head trauma)
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in PANSS Negative symptom score |
At Baseline, end of 5 days, 4 weeks, and 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in severity of illness (CGI score)
2. To understand the neurophysiological correlates of response as measured by FNIRS-oxy haemoglobin changes over DLPFC
|
Baseline and 8 weeks |
|
|
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 3 |
|
Date of First Enrollment (India)
|
18/03/2026 |
| 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="1"
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
|
Schizophrenia has negative symptoms, including anhedonia, avolition, asociality, affect blunting and alogia, associated with high disability rates. Around 33% of schizophrenia patients do not fully respond to antipsychotic pharmacotherapy, and patients with predominantly negative symptoms more resistant to treatment. Recent meta-analysis of 57 studies involving 2633 schizophrenia patients revealed that Repetitive Transcranial magnetic stimulation (rTMS) had superior efficacy in alleviating negative symptoms compared with sham interventions. Intermittent theta burst stimulation (iTBS) has been approved for the treatment of depression and explored for negative symptoms among patients with schizophrenia. Evidence suggests that accelerated iTBS protocols over the left dorsolateral prefrontal cortex (L-DLPFC) with multiple daily sessions over a short span are safe, with faster clinical improvement. However, available evidence appears insufficient to support a robust recommendation in leading treatment guidelines for negative symptoms. Thus, the effectiveness of accelerated iTBS in ameliorating the negative symptoms of schizophrenia requires more investigation. Although previous trials demonstrated the relationship between cortical activity measured by fNIRS and symptoms of schizophrenia, no study has attempted to determine whether neural activity of specific regions, measured by fNIRS, would predict clinical benefits of aiTBS on negative symptoms in schizophrenia |