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

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ClinicalTrials.gov Identifier: NCT02521883
Recruitment Status : Recruiting
First Posted : August 13, 2015
Last Update Posted : April 26, 2017
Sponsor:
Collaborators:
Tampere University Hospital
Sooma Oy
Information provided by (Responsible Party):
Turku University Hospital

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.


Condition or disease Intervention/treatment Phase
Depression Device: Sooma tDCS Device: Sham tDCS Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : March 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. Change from baseline in Beck Depression Inventory (BDI) scale. [ Time Frame: baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months ]
  3. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02521883


Contacts
Contact: Tero Taiminen, MD, docent +358-2-3131741 tero.taiminen@tyks.fi

Locations
Finland
PHSOTEY, Psykiatrian tulosalue, ECT-yksikkö Recruiting
Lahti, Finland, 15850
Contact: Mikko Pänkäläinen, MD    +358-3-8192952    mikko.pankalainen@phsotey.fi   
VSSHP Psykiatria, Liedon aikuispsykiatrian poliklinikka Recruiting
Lieto, Finland, 21420
Contact: Alexander Denissoff, MD    +358-2-3145970    alexander.denissoff@tyks.fi   
Turku University Hospital Recruiting
Turku, Finland, 20521
Contact: Tero Taiminen, MD, docent    +358-2-3131741    tero.taiminen@tyks.fi   
Principal Investigator: Tero Taiminen, MD, docent         
Sweden
Sektionen för affektiva sjukdomar, Norra Stockholms Psykiatri, Stockholms läns sjukvårdsområde Recruiting
Stockholm, Stockholms län, Sweden, 10233
Contact: Johan Lundberg, MD    +46 72 560 84 67    johan.lundberg@sll.se   
Sponsors and Collaborators
Turku University Hospital
Tampere University Hospital
Sooma Oy
Investigators
Principal Investigator: Tero Taiminen, MD, docent Turku University Hospital

Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT02521883     History of Changes
Other Study ID Numbers: T248/2014
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017