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Clinical Trials/CTRI/2021/05/033784
CTRI/2021/05/033784
Recruiting
N/A

Clinical Efficacy & Neurobiological Correlates of sequential treatment with cathodal tDCS primed iTBS and ECT in Treatment-Resistant Depression

Department of Psychiatry National Institute of Mental Health and Neuro Sciences0 sites0 target enrollmentTBD

Overview

Phase
N/A
Intervention
Not specified
Conditions
Health Condition 1: F33- Major depressive disorder, recurrentHealth Condition 2: F32- Major depressive disorder, singleepisode
Sponsor
Department of Psychiatry National Institute of Mental Health and Neuro Sciences
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional

Investigators

Sponsor
Department of Psychiatry National Institute of Mental Health and Neuro Sciences

Eligibility Criteria

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;

Outcomes

Primary Outcomes

Not specified

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