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.
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.
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.
Parallel
Transcranial Magnetic Stimulation
DeviceTreatment 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.
quetiapine
DrugAfter 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
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.
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.
To compare treatment-emergent adverse events (TEAEs) between the study groups.
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This trial is not recruiting at the moment. You can still explore other options:
