HDtDCS primed iTBS in Treatment Resistant Depression.

Not Applicable

Conditions: Health Condition 1: F30-F39- Mood [affective] disorders

Registration Number: CTRI/2021/07/034656

Lead Sponsor: Central Institute of Psychiatry

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Diagnosis of Depression using Diagnostic Criteria for Research (DCR) of International Classification of Disease-10th edition (ICD-10, World Health Organization,1993)

2. Age between 18- 60 years of either sex

3. The Hamilton Rating Scale for Depression-17 score of at least 18.

4. No response to at least two separate trials of antidepressants of adequate dose and duration.

5. Right-handed.

6. Patients giving written informed consent.

Exclusion Criteria

1. Lifetime history of non-response to an adequate ECT trial (minimum of 8 sessions).

2. Patient with co morbid active substance dependence in the last 6 months, except nicotine and caffeine.

3. Suicidal intent or any psychiatric emergency.

4. Pregnancy

5. Patients with active psychotic symptoms.

6. Cardiac Pacemaker or Intracranial implant.

7. Neurological comorbidity that could substantially influence depression.

8. Unstable medical illness

9. Patients who have been co prescribed BZD >1mg Clonazepam equivalent or anti-epileptic drugs.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in depressive symptoms as measured by the Hamilton Depression Rating Scale (HAM-D) and Clinical Global Impression Scale (CGI) after 2 weeks of HDtDCS primed iTBS in patients of Treatment Resistant Depression.Timepoint: Improvement in depressive symptoms as measured by the Hamilton Depression Rating Scale (HAM-D) and Clinical Global Impression Scale (CGI) after 2 weeks of HDtDCS primed iTBS in patients of Treatment Resistant Depression.

Secondary Outcome Measures

Name	Time	Method
Changes in Nerve Growth Factor levels in the serum measured using ELISA kits after treatment with HDtDCS primed iTBS.Timepoint: Baseline-T1 <br/ ><br>1 week- T2 <br/ ><br>2 weeks- T3 <br/ ><br>4 weeks- T4