Sequential neuromodulation (cathodal tDCS primed TMS and ECT) in treatment resistant depressio

Not Applicable

• Conditions: Health Condition 1: F33- Major depressive disorder, recurrentHealth Condition 2: F32- Major depressive disorder, singleepisode

• Registration Number: CTRI/2021/05/033784
• Lead Sponsor: Department of Psychiatry National Institute of Mental Health and Neuro Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Major Depressive Disorder Diagnosis (DSM-5)

2.Right-handed (Edinburgh Handedness Inventory)

3.Hamilton Depression Rating Scale (HAMD-17) score of 18 or more

4.No clinical response to an adequate dose of two antidepressant medications (based on antidepressant treatment history form score) OR Unable to tolerate at least two separate trials of antidepressants of inadequate dose and duration, and if they are currently on a stable antidepressant regimen for at least 4 weeks before which will be continued during treatment

5.Capacity to consent for research studies as per the assessment using the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC)

6. Written informed consent.

Exclusion Criteria

1.Resistant to 3 or more antidepressants or to an adequate ECT trial

2.Suicidal intent (HAMD suicide item score of 3 or 4) / any psychiatric emergency

3.Bipolar depression;

4.Psychotic disorder or symptoms;

5.Neurological/clinical evidence of other medical comorbidity that could substantially influence depression;

6.Unstable medical illness;

7.Co-prescribed BZD >1-mg clonazepam equivalents or anti-epileptic drugs;

8.Severe general medical/neurological comorbidity that precludes ECT or has an effect on cognition and behavior;

9.Current psychoactive substance dependence (except caffeine or nicotine);

10.Pregnancy or Post-partum Period;

11.Co-morbid neurological/medical disease that can affect the brain structure/function;

12.Any contraindication for Magnetic Resonance Imaging;

13.Any contraindication for Transcranial Magnetic Stimulation;

14.Any contraindication for Transcranial Direct Current Stimulation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in Hamilton Depression Rating Scale (HAMD-17) score of more than or equal to 50% from baseline and post-treatment HAMD-17 score of 13.Timepoint: 1. Baseline <br/ ><br>2. At the end of part-1 (4-6 weeks of cTDCS/sham-tDCS primed iTBS) <br/ ><br>3. At the end of part-2 (End of 6 or more sessions of ECT)

Secondary Outcome Measures

Name	Time	Method
1. Inventory of Depressive Symptomatology-Self Report and Hamilton Anxiety Rating scale scores <br/ ><br>2. Structured assessment of disability <br/ ><br>3. Brain magnetic imaging measures (resting-state functional images, diffusion tensor images, glutamate levels at left dorsolateral prefrontal cortex from MR spectroscopy) <br/ ><br>4. Electroencephalography measures <br/ ><br>5. TMS-tDCS perturbation study metrics <br/ ><br>6. Heart Rate Variability measuresTimepoint: 1. Baseline <br/ ><br>2. At the end of part-1 (4-6 weeks of cTDCS/sham-tDCS primed iTBS) <br/ ><br>3. At the end of part-2 (End of 6 or more sessions of ECT)