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NOT YET RECRUITING
NCT07760168
PHASE3

Study of rTMS in Maintenance in Treatment Resistant Depression

Sponsor: All India Institute of Medical Sciences, Bhubaneswar

View on ClinicalTrials.gov

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.

Official title: Efficacy and Safety of Acute Followed by Maintenance rTMS in Treatment Resistant Depression: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

68

Start Date

2026-08-30

Completion Date

2028-08-30

Last Updated

2026-08-12

Healthy Volunteers

No

Interventions

DEVICE

Transcranial Magnetic Stimulation

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.

DRUG

quetiapine

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.