Trials Sponsors Conditions Drugs Pricing

Conditions

Depressive Disorder, Treatment-Resistant

Outcome Measures

Primary Outcomes (1)

Improvement in depressive symptoms as measured by mean change in the Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to end of the study.
Measurements at week 0, week 2, week 4, week 5 and week 6

Study Arms (1)

tDCS

EXPERIMENTAL

Patients will receive transcranial direct current stimulation using an adaptive protocol allowing for doses of 0 to 4 mA during the course of the treatment, with twenty 20-minute sessions over the course of 4 to 6 weeks. Anodal placement will be over the left dorsolateral prefrontal cortex region of the head, and cathodal stimulation over the right temporal region, as has been demonstrated in other studies of tDCS for depression. Treatments will take place daily, 5 days per week. This study will allow tDCS stimulation to be customized for each individual participant and their different threshold for pain.

Device: tDCS

Interventions

tDCSDevice

Transcranial direct current stimulation with placement of the anode over the F3 region of the scalp and the cathode over the right supraorbital region.

tDCS

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adults age 18 to 65
History of major depressive disorder with current depressive symptoms, as defined by DSM-IV criteria

Sponsors & Collaborators

Washington University School of Medicine
Otherlead

Study Sites (1)

Washington University in Saint Louis

St Louis, Missouri, 63110, United States

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

Charles Conway, MD
Washington University School of Medicine
PRINCIPAL INVESTIGATOR

Enrollment

5 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Masking Details: Outcomes assessors are blinded and unaware of the specifics of the study (although only a single arm, blinded raters do not know this).
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 21, 2016

First Posted

October 24, 2016

Study Start

Study Stopped

Adaptive tDCS for Treatment-Resistant MDD

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

tDCS

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

tDCS

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations