Study of rTMS in Maintenance in Treatment Resistant Depression

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorAll India Institute of Medical Sciences, Bhubaneswar

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Transcranial Magnetic Stimulation
  • quetiapine

Treatment groups

68 Participants
are divided into 2 treatment groups

Locations

This trial has no locations