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Transcranial Magnetic Stimulation / Treatment Resistant Depression (TRD) / quetiapine · Phase 3 Trial
ClinicalTrials.gov · August 12, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 3 randomized controlled trial registration comparing maintenance accelerated intermittent theta burst stimulation (aTBS) to maintenance quetiapine in patients with treatment-resistant depression who have responded to an initial course of rTMS. The study is not yet recruiting and no results have been posted to this registry record.
Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Treatment Resistant Depression (TRD); age from 18 Years; to 60 Years. Intervention: Acute iTBS + Maintenance iTBS + Treatment as Usual (TAU); Acute iTBS + Quetiapine + Treatment as Usual (TAU). Compared with: Maintenance quetiapine. n = 68. All India Institute of Medical Sciences, Bhubaneswar (location inferred from sponsor; no explicit multicenter detail provided)..
Planned enrollment: 68 participants with treatment-resistant depression Primary outcome: change in MADRS score from baseline to week 12 of maintenance phase Secondary measures include CGI assessment, relapse rates, BDNF levels, and adverse events
Secondary measures include CGI assessment, relapse rates, BDNF levels, and adverse events
The source did not state who this applies to in practice.
This is a Phase 3 trial registration with no results posted; it describes a planned study design and enrollment strategy but contains no outcome data.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Registry record from ClinicalTrials.gov (NCT07760168). This is a study registration, not published results. Lead sponsor: All India Institute of Medical Sciences, Bhubaneswar. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 68 participants (ESTIMATED). Conditions: Treatment Resistant Depression (TRD). Interventions: DEVICE: Transcranial Magnetic Stimulation; DRUG: quetiapine. Primary outcome measures: 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. 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.