A clinical trial of Trans-cranial Direct current stimulation in Depressive disorder

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2023
INTERVENTION: Intervention1: Transcranial direct current stimulation (tDCS): tDCS uses weak polarizing currents delivered through scalp electrodes to alter cortical neuron excitability. This paradigm of tDCS treatment seems to impact glutamatergic signalling through N‐methyl‐D‐aspartate (NMDA) receptors and downstream calcium‐based signalling, leading to alterations in neuronal plasticity and modulation of monoamine systems relevant to depression. We will use 2 mA of direct current using a battery‐driven constant current stimulator for 30 min/ day for ten consecutive daily sessions followed by 02 sessions a week apart. Intervention2: Transcranial dirrect current stimulation (tDCS) and Treatment as usual: tDCS uses weak polarizing currents delivered through scalp electrodes to alter cortical neuron excitability. This paradigm of tDCS treatment seems to impact glutamatergic signalling through N‐methyl‐D‐aspartate (NMDA) receptors and downstream calcium‐based signalling, leading to alterations in neuronal plasticity and modulation of monoamine systems relevant to depression. We will use 2 mA of direct current using a battery‐driven constant current stimulator for 30 min/ day for ten consecutive daily sessions followed by 02 sessions a week apart. Total duration of intervention ‐24 days. Control Intervention1: Treatment as Usual: All the patients will be receiving selective serotonin reuptake inhibitors which form 1st line drug in treatment of depression (treatment as usual). CONDITION: Health Condition 1: F320‐ Major depressive disorder, singleepisode, mild Health Condition 2: F321‐ Major depressive disorder, singleepisode, moderate Health Condition 3: F322‐ Major depressive disorder, singleepisode, severe without psychotic features PRIMARY OUTCOME: To study the impact of tDCS on levels of Cytokines, Cortisol and serum ACTH in patients of Depressive disorder. ; Plasma IL‐2, IL‐4, IL‐6, IL‐10, IL‐17a, Interferon (IFN)‐γ, TNF‐α, basal cortisol and ACTH will be measured.Timepoint: At baseline and after 6 weeks SECONDARY OUTCOME: To determine the impact of tDCS on symptoms of depression measured by Hamilton Depression Rating Scale (HDRS)Timepoint: At baseline and after 6 weeks INCLUSION CRITERIA: Patients with Depressive disorder without psychotic features currently experiencing an acute depressive episode aged between 18‐60 years and consenting for the study will be enrolled. Comorbid anxiety symptoms will be permitted.
Epistemonikos ID: 1f51326b6de4ebb6eb62eef82f89002f0b87a97c
First added on: Feb 20, 2024