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Theta burst stimulation in depression with psychotic symptoms, fMRI based study

Adjunctive bilateral sequential accelerated theta- burst stimulation at Dorsolateral prefrontal cortex in Psychotic depression: a fMRI based randomized sham controlled study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/12/060630
Enrollment
30
Registered
2023-12-21
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F323- Major depressive disorder, singleepisode, severe with psychotic features

Interventions

Intervention1: Bilateral Sequential Accelerated Theta-Burst Stimulation: Two sessions will be administered daily for 5 days in a week for 2 weeks. During each session, continuous TBS is administered f

Sponsors

Central Institute of Psychiatry
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Patients fulfilling ICD 11 DCR, supplemented with Morbidity and Mortality Statistics (February 2022 edition), criteria for Single/recurrent episode depressive disorder, Moderate/severe with psychotic symptoms (6A70.2 Single Episode Depressive Disorder, Moderate, with psychotic symptoms, 6A70.4 Single Episode Depressive Disorder, Severe, with psychotic symptoms, 6A71.2 Recurrent Depressive Disorder, Current Episode Moderate, with psychotic symptoms, 6A71.4 Recurrent Depressive Disorder, Current Episode Severe, with psychotic symptoms) (WHO, 2019). 2 Adult between age 18–50 years old of either sex. 3 Right-handed patients. 4 Patients who give informed consent.

Exclusion criteria

Exclusion criteria: 1 Age 50years 2 Patients unwilling to give informed consent 3 Any co-morbid psychiatric disorders and intellectual disability. 4 Any Substance dependence within the past 3 months except nicotine and caffeine 5 Any history of seizure 6 Any comorbid medical conditions and or Neurological diseases. 7 History of Electroconvulsive therapy (ECT) or other neuromodulation within past 3 months 8 Patient planned for ECT as decided by treating team 9 Pregnancy 10 Any contraindication to MRI or TMS (patients having implants)

Design outcomes

Primary

MeasureTime frame
1.Change in depressive symptoms assessed by change in HAM-D score after completion of TBS protocol & 14 days after last session of TBS. 2.Change in depressive symptoms assessed by change in MADRS score after completion of TBS protocol & 14 days after last session of TBS. 3.Change in psychotic symptoms assessed by change in BPRS score after completion of TBS protocol & 14 days after last session of TBS. Timepoint: Baseline, Day 14, Day 28—

Secondary

MeasureTime frame
1.Changes in functional connectivity in central executive network assessed by resting state fMRI from baseline to end of last TBS session. 2.Changes in clinical improvement as measured by CGI-I score from baseline to end of last TBS session & 14 days after last TBS session.Timepoint: Baseline,Day 14, Day 28—

Countries

India

Contacts

Public ContactDr Sourav Khanra

Central Institute of Psychiatry

souravpsy@gmail.com7903302259

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026