DepressionPhase 2/3NCT02521883
Transcranial Direct Current Stimulation (tDCS) as an add-on Therapy for Treatment of Major Depressive Disorder. (DEPTDCS2014)
A Phase 2/3 study testing Sooma tDCS in people with Depression, run by Turku University Hospital at 4 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depression
- What is being tested?
- Sooma tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Mar 2015to Mar 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Finland3 sites, 3 recruiting
- Recruiting
PHSOTEY, Psykiatrian tulosalue, ECT-yksikkö
Lahti, 15850
Mikko Pänkäläinen, MD, +358-3-8192952, mikko.pankalainen@phsotey.fi
- Recruiting
VSSHP Psykiatria, Liedon aikuispsykiatrian poliklinikka
Lieto, 21420
Alexander Denissoff, MD, +358-2-3145970, alexander.denissoff@tyks.fi
- Recruiting
Turku University Hospital
Turku, 20521
Tero Taiminen, MD, docent, +358-2-3131741, tero.taiminen@tyks.fi
Tero Taiminen, MD, docent
Sweden1 site, 1 recruiting
- Recruiting
Sektionen för affektiva sjukdomar, Norra Stockholms Psykiatri, Stockholms läns sjukvårdsområde
Stockholm, Stockholm County, 10233
Johan Lundberg, MD, +46 72 560 84 67, johan.lundberg@sll.se
About this study
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.
- Conditions
- Depression
- Being tested
- Sooma tDCS, Sham tDCS
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sooma tDCSDevice
2mA current applied for 30 minutes in electrode locations F3 (anode) and F4 (cathode).
Sham tDCSDevice
sham stimulation (current phased off after 20 secs) applied for 30 minutes in electrode locations F3 (anode) and F4 (cathode).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Montgomery-Åsberg depression scale (MADRS)
Efficacy
Measured: baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months
Secondary outcomes (3)
Dichotomised response measured with MADRS.
Response to treatment is defined as a ≥ 50% reduction in the MADRS baseline score.
Measured: baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months
Change from baseline in Beck Depression Inventory (BDI) scale.
Measured: baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months
Dichotomised remission measured with MADRS.
Remission is defined as a MADRS score ≤ 10.
Measured: baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Tampere University Hospital, Sooma Oy
- Responsible party
- Sponsor
- Investigators
- Tero Taiminen, MD, docent, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521883
- Sponsor's protocol ID
- T248/2014
- Status last verified
- Sep 2018
- First submitted
- 11 Aug 2015
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) as an add-on Therapy for Treatment of Major Depressive Disorder. (DEPTDCS2014)
- ClinicalTrials.gov ID
- NCT02521883
- Acronym / sponsor ID
- T248/2014
- Conditions
- Depression
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Tampere University Hospital, Sooma Oy
- Study start
- Mar 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device: Sooma tDCS | Active comparator | Device: Sooma tDCSThe active group will receive active Sooma tDCS treatment for the first three weeks followed by maintenance treatments at weeks 5 and 6. |
| Device: Sham tDCS | Placebo comparator | Device: Sham tDCSThe placebo group will receive sham tDCS treatment for the first three weeks followed by sham maintenance treatments at weeks 5 and 6. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sooma tDCS2mA current applied for 30 minutes in electrode locations F3 (anode) and F4 (cathode). | Device | Device: Sooma tDCS |
| Sham tDCSsham stimulation (current phased off after 20 secs) applied for 30 minutes in electrode locations F3 (anode) and F4 (cathode). | Device | Device: Sham tDCS |
Primary outcome
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
3 secondary outcomes
Dichotomised response measured with MADRS.
Time frame: 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
Dichotomised remission measured with MADRS.
Time frame: baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tero Taiminen, MD, docent principal investigator
Turku University Hospital
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sooma tDCS in people with Depression, run by Turku University Hospital at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tero Taiminen, MD, docent (+358-2-3131741, tero.taiminen@tyks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Montgomery-Åsberg depression scale (MADRS) (time frame: baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2018.