Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04159012

NESBID: Neuro-Stimulation of the Brain in Depression — NESBID  

Depressive Disorder, Major Clinical Trial

Official title:
NESBID: Neuro-Stimulation of the Brain in Depression. A Randomized, Controlled Clinical Trial of Transcranial Direct Current Stimulation Augmentation, as Compared to Sham Therapy, in the Treatment of Ultra-resistant Major Depressive Disorder

Clinical Trial Summary

In Canada, approximately 20% of patients with Major Depressive Disorder (MDD) have treatment-resistance and fail to respond to trials of pharmacotherapy or psychotherapy. Although the treatment of choice has historically consisted of electroconvulsive therapy (ECT), this is not always feasible or practical, and carries a risk of side-effects that may be unacceptable to certain patients. In this pragmatic, multi-site, placebo-controlled and double-blinded clinical trial, participants with ultra treatment-resistant MDD will be randomized to receive either active or sham transcranial direct current stimulation in addition to their usual treatment. Ultra treatment-resistant depression will be operationally defined as MDD that has failed to respond to at least five previous trials of antidepressants at sufficient doses, or ECT, or ketamine. Patients will receive a total of 30 active or sham treatment sessions (5 per week), for 30 minutes per session. In both groups, the anode will be placed over the left dorsolateral prefrontal cortex (position F3), and the cathode over the right dorsolateral prefrontal cortex (position F4). Patients in the sham group will receive electrical stimulation at 2 mA for less than 30 seconds, whereas patients in the active group will receive that level of stimulation for the entire duration of treatment. The study's primary outcome is the change in score on a clinician-graded depression inventory (the Montgomery-Asberg Depression Rating Scales). Secondary outcomes include change in scores on a self-administered depression rating scale and measurement of function scale. Information on language ability will also be collected, as will data on side-effects of treatment. Scores will be collected before the trial start, after every 10 sessions, and one month after trial completion.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04159012
Study type Interventional
Source University of Alberta
Contact
Status Active, not recruiting
Phase N/A
Start date September 1, 2020
Completion date December 1, 2024
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05915013 - Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response Phase 1
Completed NCT04469322 - Pharmacogenetic Implementation Trial in Veterans With Treatment Refractory Depression N/A
Recruiting NCT05415397 - Treating Immuno-metabolic Depression With Anti-inflammatory Drugs Phase 3
Recruiting NCT05988333 - Psychoeducational Intervention for Families With a Member Affected by Major Depression N/A
Completed NCT02919501 - Study of the Efficacy and Safety of Initial Administration of 17 mg Vortioxetine Intravenously With 10 mg/Day Vortioxetine Orally in Patients With Major Depressive Disorder Phase 2
Completed NCT00976560 - Clinical Study to Test a New Drug to Treat Major Depression Phase 2
Recruiting NCT05518149 - A Study of Aticaprant in Adult and Elderly Participants With Major Depressive Disorder (MDD) Phase 3
Not yet recruiting NCT06303076 - Tizanidine vs. Zolpidem in Primary Insomnia: A Randomized Trial Phase 4
Not yet recruiting NCT05901571 - Acupuncture and Escitalopram for Treating Major Depression Clinical Study N/A
Suspended NCT02546024 - Predictors of Treatment Response in Late-onset Major Depressive Disorder N/A
Completed NCT02452892 - Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD) N/A
Completed NCT01407575 - Buprenorphine for Treatment Resistant Depression Phase 3
Completed NCT01583400 - Enhanced Collaborative Depression Treatment in Primary Care: The RESPECT-D-E Trial N/A
Completed NCT01152996 - Safety and Tolerability of Vortioxetine (LuAA21004) - Open Label Extension Study Phase 3
Enrolling by invitation NCT00762866 - Psychiatric Genotype/Phenotype Project Repository
Completed NCT00369343 - Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) Versus Placebo in Peri- and Postmenopausal Women Phase 3
Completed NCT00366652 - Study Evaluating the Effects of DVS SR and Duloxetine on the Pharmacokinetics of Desipramine in Healthy Subjects Phase 3
Completed NCT00384033 - Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder Phase 3
Completed NCT00149643 - Effectiveness of Fluoxetine in Young People for the Treatment of Major Depression and Marijuana Dependence Phase 2
Completed NCT00316160 - Sexual Functioning Study With Antidepressants Phase 4