Clinical trial NCT05194267: Intensive tDCS for MDD: Feasibility Study
Official title: Intensive Transcranial Direct Current Stimulation in the Treatment of Major Depression: Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label feasibility study
Primary purpose: TREATMENT

Brief summary: This will be a prospective, open-label, single-arm study to determine the safety and feasibility of an intensive treatment of transcranial direct current stimulation (tDCS) for major depressive disorder (MDD). Participants will be age 18-65 with a diagnosis of unipolar MDD. Participants will receive an intensive treatment of tDCS over a 10-day treatment period and complete follow-up assessments at the end of treatment, 1, and 4 weeks post-treatment.

Detailed description: This will be a prospective, open-label, single-arm study to determine the safety and feasibility of an intensive treatment of transcranial direct current stimulation (tDCS) for major depressive disorder (MDD). Secondary objective is to gather preliminary data on the clinical effects of the protocol. After assessment and inclusion into the study, participants will receive up to 50 tDCS sessions over 10 days.

Study procedures:

Daily assessments: brief questions before and after each tDCS session to evaluate potential adverse events as well as a verbal rating scale for pain.

Questionnaires : a battery of mood questionnaires will be completed to inform findings regarding clinical effects of the treatment.

Cognitive measures: a short cognitive assessment will be completed to inform findings regarding cognitive safety of the treatment.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Major unipolar depression for at least 4 weeks meeting the criteria of the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5)
* Age between 18 to 65
* Minimum score of 17 on the GRID-Hamilton Depression Rating Scale (GRID-HAMD)

Exclusion Criteria:

* Bipolar disorder,
* Psychosis
* Active substance use disorder (in the last 3 months)
* Personality disorder
* Neurocognitive disorder
* High risk of suicide
* Major comorbid medical or neurological condition
* Pregnancy

Medical contraindications to tDCS:

* Ferromagnetic material in the skull
* Defect in the bone substance of the skull
* Dermatological condition (e.g. eczema, psoriasis, urticaria, dermatitis, acne, hyperhidrosis, folliculitis, rosacea, keratosis, herpes, infectious or neoplastic phenomenon, etc.)
* Skin lesion on the skull (ex: cuts, abrasions, rash, tattoos on the skull, piercings on the head, etc.)

Primary outcomes:
measure: Feasibility-related endpoints - adherence to tDCS
timeFrame: after 10 days of treatment sessions
measure: Feasibility-related endpoints - retention rates
timeFrame: after 10 days of treatment sessions
measure: Adverse Events reported
timeFrame: up to one month after end of the treatment
Secondary outcomes:
measure: Response rate (> 50% improvement) and remission rate (score <7) using GRID-Hamilton Depression Rating Scale (GRID-HAMD)
timeFrame: T1 (one week after end of the treatment) and T2 (one month after end of the treatment)
measure: Percentage change on Hamilton Rating Scale for Depression (HAMD-6)
timeFrame: T0 (baseline) and T2 (one month after the end of the treatment)
measure: Percentage change on Patient Health Questionnaire (PHQ-9)
timeFrame: T0 (baseline) and T2 (one month after the end of the treatment)
measure: Percentage change on General Anxiety Disorder (GAD-7)
timeFrame: T0 (baseline) and T2 (one month after the end of the treatment)
measure: Percentage change on Rey Auditory Verbal Learning Scale (RAVLT).
timeFrame: T0 (baseline) and T1 (one week after end of the treatment)
measure: Percentage change on Rey-Osterrieth Complex Figure (ROCF)
timeFrame: T0 (baseline) and T1 (one week after end of the treatment)
measure: Percentage change on Trail Making Test parts A&B
timeFrame: T0 (baseline) and T1 (one week after end of the treatment)
measure: Percentage change on the Controlled Oral Word Association (COWAT)
timeFrame: T0 (baseline) and T1 (one week after end of the treatment)
Other outcomes:
measure: Interim Analysis-GRID-Hamilton Depression Rating Scale (GRID-HAMD)
timeFrame: After the first 10 patients are completed
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM)
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Jean-Philippe Miron, MD
role: PRINCIPAL_INVESTIGATOR
References: