NCT02521883

Brief Summary

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2 depression

Timeline
Completed

Started Mar 2015

Longer than P75 for phase_2 depression

Geographic Reach
2 countries

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

September 12, 2018

Status Verified

September 1, 2018

Enrollment Period

4.8 years

First QC Date

August 11, 2015

Last Update Submit

September 11, 2018

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in Montgomery-Åsberg depression scale (MADRS)

    Efficacy

    baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months

Secondary Outcomes (3)

  • Dichotomised response measured with MADRS.

    baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months

  • Change from baseline in Beck Depression Inventory (BDI) scale.

    baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months

  • Dichotomised remission measured with MADRS.

    baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months

Study Arms (2)

Device: Sooma tDCS

ACTIVE COMPARATOR

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

Device: Sham tDCS

PLACEBO COMPARATOR

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

Interventions

Sooma tDCSDEVICE

2mA current applied for 30 minutes in electrode locations F3 (anode) and F4 (cathode).

Device: Sooma tDCS
Sham tDCSDEVICE

sham stimulation (current phased off after 20 secs) applied for 30 minutes in electrode locations F3 (anode) and F4 (cathode).

Device: Sham tDCS

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

PHSOTEY, Psykiatrian tulosalue, ECT-yksikkö

Lahti, 15850, Finland

RECRUITING

VSSHP Psykiatria, Liedon aikuispsykiatrian poliklinikka

Lieto, 21420, Finland

RECRUITING

Turku University Hospital

Turku, 20521, Finland

RECRUITING

Sektionen för affektiva sjukdomar, Norra Stockholms Psykiatri, Stockholms läns sjukvårdsområde

Stockholm, Stockholm County, 10233, Sweden

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Tero Taiminen, MD, docent

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tero Taiminen, MD, docent

CONTACT

+358-2-3131741tero.taiminen@tyks.fi

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2015

First Posted

August 13, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2019

Study Completion

March 1, 2020

Last Updated

September 12, 2018

Record last verified: 2018-09

Locations

FI(3)SE(1)