Study of rTMS in Maintenance in Treatment Resistant Depression

NCT07760168 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: AIIMSBBSR/PG Thesis/2026-27/82
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Treatment Resistant Depression (TRD)

Outcome Measures

Primary Outcomes (1)

• 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

  Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 12

Secondary Outcomes (3)

• 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.

  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.

  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.

  Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) during the 12-Week Study Period

Study Arms (2)

Acute iTBS + Maintenance iTBS + Treatment as Usual (TAU)

ACTIVE COMPARATOR

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

Acute iTBS + Quetiapine + Treatment as Usual (TAU)

ACTIVE COMPARATOR

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

Interventions

Transcranial Magnetic Stimulation DEVICE

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.

Acute iTBS + Maintenance iTBS + Treatment as Usual (TAU)

quetiapine DRUG

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.

Acute iTBS + Quetiapine + Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of both genders, between the ages 18- 60 years
• Clinically diagnosed as depression according to ICD-11.
• Diagnosis of treatment resistance depression according to US-FDA.
• On stable dosing of antidepressant venlafaxine 150 mg per day.
• Right-handed.

You may not qualify if:

• Pregnant or lactating women.
• Any kind of psychiatric emergency (E.g., Suicide risk, Catatonia, aggression or excitement)
• Any co-morbid neurological disease
• History of seizure/ epilepsy.
• History of migraine.
• History of head trauma/ organic brain condition.
• Any contraindications to rTMS procedure:
• Metallic or electronic implants in the brain or heart, or any cochlear implants
• Injury or local lesion in the scalp/head.

Sponsors & Collaborators

• All India Institute of Medical Sciences, Bhubaneswar: lead

Related Publications (2)

• Noda Y, Wada M, Mimura Y, Taniguchi K, Tarumi R, Moriyama S, Arai N, Tsugawa S, Thorpe KE, Daskalakis ZJ, Uchida H, Mimura M, Blumberger DM, Nakajima S. Repetitive Transcranial Magnetic Stimulation as Maintenance Treatment of Depression: The MAINT-R Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2515881. doi: 10.1001/jamanetworkopen.2025.15881.

  PMID: 40522661 BACKGROUND

• Arns M, Bervoets C, van Eijndhoven P, Baeken C, van den Heuvel OA, Aleman A, Schutter DJLG, van der Werf Y, van Belkum S, Sommer IE, van Ruth R, Haarman B, Spijker J, Sack AT. [Consensus statement on the application of rTMS in depression in the Netherlands and Belgium]. Tijdschr Psychiatr. 2019;61(6):411-420. Dutch.

  PMID: 31243751 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Transcranial Magnetic Stimulation; Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFFESOR

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): August 30, 2028
• Last Updated: August 12, 2026

Record last verified: 2026-08