A Phase 3 interventional study of Transcranial Magnetic Stimulation and quetiapine in Treatment Resistant Depression (TRD), sponsored by All India Institute of Medical Sciences, Bhubaneswar. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by All India Institute of Medical Sciences, Bhubaneswar · Phase 3, Interventional, and Treatment
The goal of this clinical trial is to learn which treatment works better to help people with treatment-resistant depression stay well after they improve with repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation treatment. It will also learn about the safety of maintenance rTMS and maintenance quetiapine.
The main questions it aims to answer are:
Does maintenance rTMS help prevent depression from returning better than maintenance quetiapine? Do participants receiving maintenance rTMS have greater improvement in depression symptoms over time than those receiving maintenance quetiapine? What side effects or medical problems occur with each treatment?
Researchers will compare maintenance rTMS with maintenance quetiapine after all participants have completed the initial course of rTMS.
Participants will:
Receive an initial course of rTMS. Be randomly assigned to receive either maintenance rTMS or maintenance quetiapine.
Attend regular follow ups to assess depression symptoms with MADRS , assess overall improvement by CGI , and any side effects.
Provide blood samples at selected visits to measure brain-derived neurotrophic factor (BDNF), a protein that may be be linked to recovery from depression.
Be followed for several months to monitor whether their depression returns and how well they continue to improve.
Treatment-resistant depression (TRD) is a major cause of disability and is associated with persistent symptoms, reduced quality of life, increased healthcare utilization, and a high risk of relapse despite evidence-based treatment. Although repetitive transcranial magnetic stimulation (rTMS) is an established treatment for TRD, many patients experience recurrence of depressive symptoms after completion of the acute treatment course. At present, there is no universally accepted maintenance strategy following successful acute rTMS.
Maintenance rTMS has shown promise in reducing relapse; however, existing randomized studies have primarily compared maintenance rTMS with sham stimulation, antidepressants, or lithium. No randomized controlled trial has directly compared maintenance accelerated intermittent theta burst stimulation (aiTBS) with quetiapine augmentation, despite quetiapine having Level 1 evidence as an augmentation strategy for TRD in the Canadian Network for Mood and Anxiety Treatments (CANMAT) guidelines. This represents an important gap in evidence for long-term management following acute neuromodulation.
The present study is a hospital-based, investigator-initiated, randomized, open-label, rater-blinded, parallel-group clinical trial conducted at the Department of Psychiatry, AIIMS Bhubaneswar. All participants will receive an acute course of accelerated intermittent theta burst stimulation while continuing treatment as usual (TAU). Following completion of the acute phase, participants will be randomly allocated to receive either maintenance aiTBS or quetiapine augmentation in addition to TAU. This design allows direct comparison of two evidence-based maintenance approaches after a common acute neuromodulation intervention.
The study will evaluate whether maintenance aiTBS provides sustained clinical benefit comparable or superior to quetiapine augmentation while maintaining an acceptable safety profile. In addition to clinical assessments, the study will examine changes in serum brain-derived neurotrophic factor (BDNF), a biomarker associated with neuroplasticity, to explore its relationship with treatment response during the maintenance phase.
The findings from this trial are expected to provide evidence regarding the comparative effectiveness and safety of maintenance neuromodulation versus pharmacological augmentation after acute rTMS in treatment-resistant depression. The results may help inform future maintenance treatment strategies and improve long-term outcomes for individuals with TRD.
448 studies on the registry are indexed under Depressive Disorder, Treatment-Resistant; 147 are open to participants now.
This study's planned enrollment of 68 is above the median of 59 across 372 interventional studies indexed under Depressive Disorder, Treatment-Resistant.
Browse Depressive Disorder, Treatment-Resistant studies →All India Institute of Medical Sciences, Bhubaneswar is the lead sponsor of 59 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Any co-morbid neurological disease
Any to rTMS procedure:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Arm 1 (aiTBS + TAU) Accelerated iTBS will be provided with a 100X transcranial magnetic stimulator with a 70 mm active cooled figure of eight coil. The parameters to be given are 3 pulses, frequency- 50 Hz bursts, 2 seconds on and 10 seconds off for 3 minutes and a total of 600 pulses per session. Each patient will receive 5 sessions per week for 4 weeks with a total of 20 sessions. Considering the high frequency of stimulation a round of three iTBS per treatment will be given separated by 15minutes, a total of 1800 pulses per day. The sessions will be given after calculating a resting motor threshold. Stimulation target will be dorsolateral prefrontal cortex.
Device: Transcranial Magnetic Stimulation
The active intervention consists of Quetiapine Extended-Release (XR) administered once daily. Treatment will be individually tailored to patient requirements, with the daily maintenance dose adjusted between 100 mg and 200 mg based on clinical efficacy and side-effect tolerability.
Drug: quetiapine
Treatment Schedule: After completion of acute treatment with rTMS, Patients will receive 5 days of treatment (as per previously mentioned schedule) per week for one week only in a month for maintenance sessions, for a total patient treatment duration of 3 months.
After completion of acute course of rTMS, Patients will receive Quetiapine as a pharmacological augmentation to their standard TAU, dosed and titrated as per standard clinical guidelines for Treatment-Resistant Depression.
To compare the efficacy of maintenance accelerated intermittent theta burst stimulation vs Quetiapine on symptomatology in terms of change in MADRS score in patients with treatment resistance depression
Time frame: Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 12
To compare the efficacy of maintenance accelerated intermittent theta burst stimulation vs Quetiapine on biomarker in terms of change in BDNF levels in patients with treatment resistance depression.
Time frame: Change From Baseline in Serum Brain-Derived Neurotrophic Factor (BDNF) Levels at 12 Weeks.
To compare the efficacy of maintenance accelerated intermittent theta burst stimulation vs Quetiapine on severity of illness in terms of change in CGI score in patients with treatment resistance depression.
Time frame: Change From Baseline in Clinical Global Impression-Improvement (CGI-I) and Clinical Global Impression- Severity (CGI-S) Score at 12 Weeks
To compare treatment-emergent adverse events (TEAEs) between the study groups.
Time frame: Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) during the 12-Week Study Period
No study locations are listed for this record.
Plan to share: Undecided
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Depressive Disorder, Treatment-Resistant →
All India Institute of Medical Sciences, Bhubaneswar