Optimizing the clinical effectiveness of Theta Burst Stimulation (TBS) treatment for individuals with depression (Study 1)

Not Applicable

Recruiting

• Conditions: Treatment resistant depression; Mental Health - Depression

• Registration Number: ACTRN12622001250729
• Lead Sponsor: Australian National University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-16
• Last Update Posted: 11 March 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Diagnosis of major depressive episode (MDE), in accordance with the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5), in the context of unipolar major depressive disorder or bipolar affective disorder.

18-85 years of age.

Treatment resistant depression at Stage I of the Thase and Rush classification.

Hamilton Depression Rating Scale (HAMD) score of >17 (moderate – severe depression).

No increase or initiation of new antidepressant therapy in the four weeks prior to screening.

Demonstrated capacity to give informed consent.

Exclusion Criteria

Inability to provide informed consent

Medically unstable patients

Concomitant neurological disorder or a history of a seizure disorder.

Patients who are pregnant or breastfeeding.

Active suicidal intent

Any psychotic disorder or current active psychotic symptoms

Patients who have intracranial implants deemed unsafe for TMS.

Significant difficulties with English communication and comprehension.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total score on the 17 item Hamilton Depression Rating Scale (HAMD).[ The primary analysis will be on mean HAMD scores from baseline to treatment end (completion of 35 treatment sessions) for each primary comparison.]