NCT05595356

Home-based Transcranial Direct Current Stimulation for Treatment Resistant Depression

Recruiting now NA Last updated 30 April 2024

What this trial tests

NA trial testing transcranial direct current stimulation in Treatment Resistant Depression in 106 participants. Currently enrolling.

Timeline

1 July 2022

Primary endpoint
30 June 2025

20 December 2025

Quick facts

Lead sponsor	Hospital de Clinicas de Porto Alegre
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	106
Start date	1 July 2022
Primary completion	30 June 2025
Estimated completion	20 December 2025
Sites	1 location across Brazil

Drugs / interventions tested

• transcranial direct current stimulation
• sham transcranial direct current stimulation
• run-in sham transcranial direct current stimulation
• Psychoeducation video
• Tutorial video

Conditions studied

• Treatment Resistant Depression — all drugs for Treatment Resistant Depression →

Sponsor

Hospital de Clinicas de Porto Alegre

Who can join

18 and older, any sex, with Treatment Resistant Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this phase II, randomized, double-blind clinical trial is to evaluate the effect of home-based transcranial direct current stimulation (tDCS) in patients with treatment-resistant depression. Major depressive disorder is defined by depressed mood and/or loss of interest in activities, during most of the day, nearly every day, for at least two weeks. It is usually accompanied by other symptoms, such as fatigue, sleep disturbances, thoughts of guilt, suicidal ideation, appetite alterations, difficulty to focus and physical agitation or retardation. It is estimated that its worldwide prevalence is 5%, affecting 280-300 million people. A third of patients with depression will develop treatment resistant depression, where symptoms fail to remit after at least two trials of antidepressants. Beyond psychotropics, another treatment option is neuromodulation, where excitatory or inhibitory signals are delivered to the brain, in order to modulate cortical excitability. The tDCS is a non-invasive brain stimulation method that applies a low intensity direct current (1-2mA) directed to the scalp via the cathode and anode electrodes. The current reaches the cortex, facilitating hyperpolarization or depolarization of the axonal membrane potential. Evidence has shown that this method is presented as a technique able to alter cortical and subcortical neural networks. This technique has been used to treat psychiatric disorders such as depression, bipolar affective disorder, panic, hallucinations, obsessive compulsive disorder, schizophrenia, withdrawal, rehabilitation after stroke and pain syndromes such as neuropathic pain, migraine and fibromyalgia. It has a low cost and less side effects than psychotropic medications. In order to be effective, daily repeated sessions of 20-40 minutes are necessary. When applied in a hospital setting, this frequency of sessions can limit its appliance, especially for depressed patients, whose symptoms include fatigue and loss of interest in activities. Furthermore, transportation costs, frequent absences from work and other activities and overload of the healthcare system would also limit its use. Home based devices are portable and easily operated. Thus, it is possible for patients to administer themselves the treatment, in their own home, everyday. Therefore, the aim of this study is to evaluate the effect of home-based tDCS in treatment resistant depression patients in long-term treatment.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.