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Study of rTMS in Maintenance in Treatment Resistant Depression

NCT07760168 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2026-08-12

No results posted yet for this study

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)

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.

Sponsors & Collaborators

  • All India Institute of Medical Sciences, Bhubaneswar

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-30
Primary Completion
2028-08-30
Completion
2028-08-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07760168 on ClinicalTrials.gov