Closed loop transcranial alternating current stimulation in depression (tACS-Depression)

Not Applicable

• Conditions: Depression; Mental Health - Depression

• Registration Number: ACTRN12623001264673
• Lead Sponsor: Australian National University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-06
• Last Update Posted: 12 December 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Diagnosis of major depressive disorder as a single or recurrent episode, in accordance with the Diagnostic and Statistical Manual of Mental Disorders edition 5 (DSM-V)
-18 to 80 years of age
- Montgomery-Asberg Depression Rating Scale (MADRS) score of > 19 ( moderate-severe depression)
- No change or initiation of new antidepressant (or other psychoactive) therapy in the four weeks prior to treatment
- Demonstrated capacity to give informed consent

Exclusion Criteria

- Inability to provide informed consent
- Medically unstable
- concomitant active neurological disorder
- Patients who are pregnant or breastfeeding
- Active suicidal intent
- Any psychotic disorder or current active psychotic symptoms
- Patients with intracranial implants
- Another Axis I or Axis II disorder judged to impact on the likelihood of response to treatment.
- fails tACS safety screening (e.g. says yes to having a metal implant in head)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in clinical severity of Depression[Measured by mean reductions and response and remission criteria on the clinician rated Montgomery-Asberg Depression Rating Scale (MADRS) Baseline, mid-treatment (~week 2 post baseline) and end of treatment (~week 4 post baseline). ]

Secondary Outcome Measures

Name	Time	Method
Changes in theta power [Measured by EEG at 1) rest, 2) during completion of an emotion processing task, and 3) during completion of a working memory task. This will be assessed as a composite outcome. baseline and post-treatment (within 3 days of final treatment session)];Changes in clinical severity of Depression and anxiety[Measured using a self-report questionnaire, Inventory for Depression and Anxiety Symptoms (IDAS-II) End of each treatment week (~4 weeks of treatment)];Changes in behavioural performance [measured using EEG data collected for emotional processing (Stroop task) Baseline and post-treatment (within 3 days of final treatment session)];Changes in behavioural performance[measured using EEG data collected for working memory assessment (n-back task) Baseline and post-treatment (within 3 days of final treatment session)]