Transcranial Direct Current Stimulation (tDCS) as an add-on Therapy for Treatment of Major Depressive Disorder. (DEPTDCS2014)

September 11, 2018 updated by: Turku University Hospital

The aim is to investigate the safety and effectiveness of transcranial Direct Current Stimulation (tDCS) in patients with moderate to severe major depression compared to patients treated with conventional therapy. The tDCS will be used as add-on to conventional therapy.

This is a randomized 2-arm parallel, double blind study comparing 2 groups of 60 patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Lahti, Finland, 15850
        • Recruiting
        • PHSOTEY, Psykiatrian tulosalue, ECT-yksikkö
        • Contact:
      • Lieto, Finland, 21420
        • Recruiting
        • VSSHP Psykiatria, Liedon aikuispsykiatrian poliklinikka
        • Contact:
      • Turku, Finland, 20521
        • Recruiting
        • Turku University Hospital
        • Contact:
        • Principal Investigator:
          • Tero Taiminen, MD, docent
  • Sweden
    • Stockholms Län
      • Stockholm, Stockholms Län, Sweden, 10233
        • Recruiting
        • Sektionen för affektiva sjukdomar, Norra Stockholms Psykiatri, Stockholms läns sjukvårdsområde
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Fulfils the ICD-10 diagnostic criteria for moderate or severe major depressive episode (F32), or recurrent major depressive episode (F33)
  • Able to understand the purpose and potential risks of the study
  • Able to sign informed consent

Exclusion Criteria:

  • intracranial metal implants or other foreign intracranial metal object
  • history of neurological conditions e.g. epilepsy, stroke (ischemic or haemorrhagic); brain tumor; increased intracranial pressure etc.
  • schizophrenia
  • bipolar disorder
  • psychotic disorder
  • substance abuse or dependency
  • contra-indications to tDCS
  • personality disorder that may prevent him/her to commit to the study
  • skin lesion in the area of stimulation
  • planned treatment of current depressive episode with ECT or rTMS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Device: Sooma tDCS
The active group will receive active Sooma tDCS treatment for the first three weeks followed by maintenance treatments at weeks 5 and 6.
Device: Sooma tDCS
2mA current applied for 30 minutes in electrode locations F3 (anode) and F4 (cathode).
PLACEBO_COMPARATOR: Device: Sham tDCS
The placebo group will receive sham tDCS treatment for the first three weeks followed by sham maintenance treatments at weeks 5 and 6.
Device: Sham tDCS
sham stimulation (current phased off after 20 secs) applied for 30 minutes in electrode locations F3 (anode) and F4 (cathode).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Montgomery-Åsberg depression scale (MADRS)
Time Frame: baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months
Efficacy
baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dichotomised response measured with MADRS.
Time Frame: baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months
Response to treatment is defined as a ≥ 50% reduction in the MADRS baseline score.
baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months
Change from baseline in Beck Depression Inventory (BDI) scale.
Time Frame: baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months
baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months
Dichotomised remission measured with MADRS.
Time Frame: baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months
Remission is defined as a MADRS score ≤ 10.
baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Collaborators

Tampere University Hospital
Sooma Oy

Investigators

  • Principal Investigator: Tero Taiminen, MD, docent, Turku University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2019

Study Completion (ANTICIPATED)

March 1, 2020

Study Registration Dates

First Submitted

August 11, 2015

First Submitted That Met QC Criteria

August 11, 2015

First Posted (ESTIMATE)

August 13, 2015

Study Record Updates

Last Update Posted (ACTUAL)

September 12, 2018

Last Update Submitted That Met QC Criteria

September 11, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T248/2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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