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Study of rTMS in Maintenance in Treatment Resistant Depression

Not Yet RecruitingPhase 3

Sponsor: All India Institute of Medical Sciences, Bhubaneswar

Conditions: Treatment Resistant Depression (TRD)

Interventions: Transcranial Magnetic Stimulation, quetiapine

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Pregnant or lactating women.
2. Any kind of psychiatric emergency (E.g., Suicide risk, Catatonia, aggression or excitement)
3. Any co-morbid neurological disease

   1. History of seizure/ epilepsy.
   2. History of migraine.
   3. History of head trauma/ organic brain condition.
4. Any contraindications to rTMS procedure:

   1. Metallic or electronic implants in the brain or heart, or any cochlear implants
   2. Injury or local lesion in the scalp/head.