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

Depression Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02521883
• Other study ID #: T248/2014
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: March 2015
• Est. completion date: March 2020

Study information

• Verified date: September 2018
• Source: Turku University Hospital
• Contact: Tero Taiminen, MD, docent
• Phone: +358-2-3131741
• Email: tero.taiminen[@]tyks.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression

Intervention

Device:
• Sooma tDCS
2mA current applied for 30 minutes in electrode locations F3 (anode) and F4 (cathode).
• Sham tDCS
sham stimulation (current phased off after 20 secs) applied for 30 minutes in electrode locations F3 (anode) and F4 (cathode).

Locations

Country	Name	City	State
Finland	PHSOTEY, Psykiatrian tulosalue, ECT-yksikkö	Lahti
Finland	VSSHP Psykiatria, Liedon aikuispsykiatrian poliklinikka	Lieto
Finland	Turku University Hospital	Turku
Sweden	Sektionen för affektiva sjukdomar, Norra Stockholms Psykiatri, Stockholms läns sjukvårdsområde	Stockholm	Stockholms Län

Sponsors (3)

Lead Sponsor	Collaborator
Turku University Hospital	Sooma Oy, Tampere University Hospital

Countries where clinical trial is conducted

Finland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Montgomery-Åsberg depression scale (MADRS)	Efficacy	baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months
Secondary	Dichotomised response measured with MADRS.	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
Secondary	Change from baseline in Beck Depression Inventory (BDI) scale.		baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months
Secondary	Dichotomised remission measured with MADRS.	Remission is defined as a MADRS score = 10.	baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months