Major Depressive DisorderNCT05202119
Empower: tDCS for Major Depressive Disorder at Home
A study testing Transcranial direct current stimulation in people with Major Depressive Disorder, run by Flow Neuroscience AB at 2 sites in 2 countries.
Trial summary
A two-center trial to investigate whether or not active stimulation with the Flow FL-100 tDCS device is superior to sham stimulation for the treatment of major depressive disorder when used at home. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 May 2022to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be ≥18 years.
- Have a diagnosis of Unipolar MDD with a current depressive episode as defined by the diagnostic criteria in the Diagnostic and statistical manual of mental disorders - 5th edition (DSM-V)
- Have a Hamilton Depression Rating Score (HDRS-17) of ≥ 16.
- Have PHQ-9 of ≥10.Montgomery-Åsberg Depression Rating Scale Self-Report (MADRS-s) of ≥ 20.
- For 6 weeks prior to enrollment, are either: not taking antidepressant medication or:
- are taking a stable antidepressant regimen with a stable medication source and agree to continue the same regimen throughout study participation
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- If in psychotherapy, have maintained stable psychotherapy for at least 6 weeks prior to enrollment.
- Have access to a stable internet connection through which the treatment will be received.
- Have access to a smartphone or other device running Android 5.0+ or iPhone Operating System (iOS) 12+ (e.g., reasonably new iPhone/iPad or Android phone), used to using the device in their everyday life, and can capably use the study application on the device, as determined by the investigator.
- Are currently living in England/Wales (UK) or Texas (US).
- Subject is currently under the care of a psychiatrist or a primary care physician, agrees to be evaluated at regular intervals by a psychiatrist or primary care physician for the duration of study participation, and agrees to promptly inform the study staff of any change of psychiatric or mental health providers during study participation.
- Subject agrees to allow any and all forms of communication between the investigators/study staff and any healthcare provider who currently provides and/or has provided service to the patient/subject within at least two years of study enrollment.
- Subject agrees to provide the name and verifiable contact information (email and mailing addresses, mobile and land-line phone numbers, as applicable) of at least two persons ≥ age 18 (22 in the US) who reside within a 60-minute drive of the patient's residence and whom the research staff is at liberty to contact, as they deem necessary, for the duration of study participation.
- Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study.
- Be willing and able to comply with all study procedures.
- Subject agrees to meet all of the inclusion criteria throughout their participation in the study. Otherwise, the subject will be discontinued from the study.
- Subject agrees to a Safety/Suicide Risk Management Protocol, which is intended to reduce the reduce the risk of suicide during study participation.
Who cannot join
- Are in a current state of mania, as determined by the YMRS or psychosis, as determined by the MINI.
- Are diagnosed with vitamin or hormonal deficiencies that may mimic mood disorders, as determined by the investigator.
- Are currently receiving any other interventional therapy for MDD other than a stable regimen of antidepressants or psychotherapy as defined in the inclusion criteria.
- Considered to have treatment resistant depression as defined by inadequate clinical response to 2 or more trials of antidepressants at an adequate dose and duration.
- Have a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), cranial electrotherapy stimulation (CES), transcranial direct current stimulation (tDCS), deep brain stimulation (DBS), or other brain stimulation.
- Patient answers Yes to Questions 4, 5 or 6 on the Columbia Suicide Severity Rating Scale (C-SSRS) Triage and Risk Identification Screener.
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- Any previous hospitilization for suicidal behavior.
- Have chronic or current severe insomnia (< 4 hours of sleep each night), or sleep apnea.
- Have any structural lesion (e.g., any structural neurological condition, or more subcortical lesions than would be expected for age or have had a stroke that affects stimulated area or connected areas) or any other clinically significant abnormality that might affect safety, study participation, or confound interpretation of study results, as determined by the investigator.
- Have any implant in the brain (e.g., DBS) or neurocranium, or any other active implantable medical device.
- Have any neurocranial defect.
- Have a history of epilepsy or seizures (including history of withdrawal / provoked seizures).
- Have shrapnel or any ferromagnetic material in the head.
- Have any disorder that would impair the ability to complete the study questionnaires.
- Have been diagnosed with autism spectrum disorder.
- Are actively abusing substances (<1 week prior to enrollment).
- Have a cognitive impairment (including dementia).
- Have a history of mania or psychosis.
- Are currently using any medications that affect cortical excitability (e.g., benzodiazepines, epileptics, etc.).
- Are currently experiencing symptoms of withdrawal from alcohol or benzodiazepines.
- Have been diagnosed with Parkinsonism or other movement disorder as determined by the investigator to interfere with treatment.
- Have ever taken esketamine / ketamine for treatment of depression.
- Have ever been admitted to hospital for depression.
- Have been diagnosed with obsessive-compulsive disorder (OCD), bipolar type 1 or 2 disorder, an active primary anxiety disorder, PTSD, agoraphobia, panic or personality disorder.
- Have a history of psychosurgery for depression.
- Have any history of myocardial infarction, coronary artery bypass graft (CABG), coronary heart failure (CHF), or history of other cardiac issues.
- Are currently experiencing or have a history of intractable migraines.
- Are a chronic tobacco smoker, as defined by smoking >100 cigarettes (including hand-rolled cigarettes, cigars, cigarillos, etc.) in their lifetime and has smoked every day in the last 7 days.
- If female and of child-bearing potential, currently pregnant or breastfeeding or planning to become pregnant or breastfeed any time during the study.
- Are currently a prisoner.
- Are participating concurrently in another clinical investigation or have participated in a clinical investigation within the last 90 days or intend to participate in another clinical investigation during the study.
- Have any medical condition or other circumstances, in the judgment of the investigator, that might interfere with the ability to complete follow-up visits and the self-reported MADRS-s in the app.
- Have any condition which, in the judgment of the Investigator, would preclude adequate evaluation of the device's safety and performance.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United Kingdom1 site
School of Psychology, University East London
London, London, E16 2RD
About this study
Official title: Empower: Transcranial Direct Current Stimulation in Major Depressive Disorder: a Double-blind, Placebo-controlled, Randomized, Superiority Trial
A two-center trial to investigate whether or not active stimulation with the Flow FL-100 tDCS device is superior to sham stimulation for the treatment of major depressive disorder when used at home.
Participants perform up to 36 tDCS sessions by themselves without supervision during a blinded 10-week phase, and then 30 more sessions during an unblinded open-label phase.
- Conditions
- Major Depressive Disorder
- Being tested
- Transcranial direct current stimulation, Sham Transcranial direct current stimulation
- Keywords
- tDCS
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
Transcranial direct current stimulation (tDCS) a non-invasive brain stimulation technique where a weak direct current (2 mA) is applied on the scalp through electrodes. The current modulates the underlying neural activity. The sessions are 30 minutes, 3-5 time a week.
Sham Transcranial direct current stimulationDevice
To blind the participants of the stimulation, a standardized sham protocol is used where the current ramped up and then down breifly in the beginning and end of each session to simulate active stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation | Active comparator | Active stimulation at 2mA Receives: Device: Transcranial direct current stimulation |
| Sham stimulation | Sham comparator | Not described Receives: Device: Sham Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDRS-17 - Hamilton Depression Ratin Scale
Comparison of mean score change based on HDRS-17 scores of the two arms at 10 weeks. Mean score change is calculated as change in score from baseline to week 10.
HDRS-17 is a clinician rated diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders.
Range of scores: 0 to 52. Higher scores represent greater severity of depressive symptoms.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start12 May 2022
- Primary completion6 Jun 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flow Neuroscience AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Texas, University of East London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202119
- Sponsor's protocol ID
- FL001
- Status last verified
- Apr 2026
- First submitted
- 9 Jan 2022
- Last updated
- 22 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Lagerberg PJ, Woodham RD, Selvaraj S, Lajmi N, Hobday H, Sheehan G, Ghazi-Noori AR, Rizvi M, Kwon SS, Orhii P, Machado-Vieira R, Soares JC, Young AH, Fidalgo AR, Rezaei H, Fu CHY. Acceptability of active and sham home-based transcranial direct current stimulation in major depression: mixed methods qualitative analysis in a randomised controlled trial. Ann Gen Psychiatry. 2025 Dec 4;25(1):1. doi: 10.1186/s12991-025-00607-4.
PubMed 41345653Woodham RD, Selvaraj S, Lajmi N, Hobday H, Sheehan G, Ghazi-Noori AR, Lagerberg PJ, Rizvi M, Kwon SS, Orhii P, Maislin D, Hernandez L, Machado-Vieira R, Soares JC, Young AH, Fu CHY. Home-based transcranial direct current stimulation treatment for major depressive disorder: a fully remote phase 2 randomized sham-controlled trial. Nat Med. 2025 Jan;31(1):87-95. doi: 10.1038/s41591-024-03305-y. Epub 2024 Oct 21.
PubMed 39433921
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empower: Transcranial Direct Current Stimulation in Major Depressive Disorder: a Double-blind, Placebo-controlled, Randomized, Superiority Trial
- ClinicalTrials.gov ID
- NCT05202119
- Acronym / sponsor ID
- FL001
- Conditions
- Major Depressive Disorder
- Keywords
- tDCS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Flow Neuroscience ABIndustry (pharma, biotech, devices)
- Collaborators
- University of Texas, University of East London
- Study start
- 12 May 2022 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 21 Jan 2022 (actual)
- Results
- Posted 22 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A two-center trial to investigate whether or not active stimulation with the Flow FL-100 tDCS device is superior to sham stimulation for the treatment of major depressive disorder when used at home.
Participants perform up to 36 tDCS sessions by themselves without supervision during a blinded 10-week phase, and then 30 more sessions during an unblinded open-label phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active stimulation | Active comparator | Device: Transcranial direct current stimulationActive stimulation at 2mA |
| Sham stimulation | Sham comparator | Device: Sham Transcranial direct current stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Be ≥18 years.
- Have a diagnosis of Unipolar MDD with a current depressive episode as defined by the diagnostic criteria in the Diagnostic and statistical manual of mental disorders - 5th edition (DSM-V)
- Have a Hamilton Depression Rating Score (HDRS-17) of ≥ 16.
- Have PHQ-9 of ≥10.Montgomery-Åsberg Depression Rating Scale Self-Report (MADRS-s) of ≥ 20.
- For 6 weeks prior to enrollment, are either: not taking antidepressant medication or:
Key exclusion criteria (33 listed)
- Are in a current state of mania, as determined by the YMRS or psychosis, as determined by the MINI.
- Are diagnosed with vitamin or hormonal deficiencies that may mimic mood disorders, as determined by the investigator.
- Are currently receiving any other interventional therapy for MDD other than a stable regimen of antidepressants or psychotherapy as defined in the inclusion criteria.
- Considered to have treatment resistant depression as defined by inadequate clinical response to 2 or more trials of antidepressants at an adequate dose and duration.
- Have a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), cranial electrotherapy stimulation (CES), transcranial direct current stimulation (tDCS), deep brain stimulation (DBS), or other brain stimulation.
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 |
|---|---|---|
| Transcranial direct current stimulationTranscranial direct current stimulation (tDCS) a non-invasive brain stimulation technique where a weak direct current (2 mA) is applied on the scalp through electrodes. The current modulates the underlying neural activity. The sessions are 30 minutes, 3-5 time a week. | Device | Active stimulation |
| Sham Transcranial direct current stimulationTo blind the participants of the stimulation, a standardized sham protocol is used where the current ramped up and then down breifly in the beginning and end of each session to simulate active stimulation. | Device | Sham stimulation |
Primary outcome
HDRS-17 - Hamilton Depression Ratin Scale
Time frame: 10 weeks
Comparison of mean score change based on HDRS-17 scores of the two arms at 10 weeks. Mean score change is calculated as change in score from baseline to week 10. HDRS-17 is a clinician rated diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Range of scores: 0 to 52. Higher scores represent greater severity of depressive symptoms.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41345653Lagerberg PJ, Woodham RD, Selvaraj S, Lajmi N, Hobday H, Sheehan G, Ghazi-Noori AR, Rizvi M, Kwon SS, Orhii P, Machado-Vieira R, Soares JC, Young AH, Fidalgo AR, Rezaei H, Fu CHY. Acceptability of active and sham home-based transcranial direct current stimulation in major depression: mixed methods qualitative analysis in a randomised controlled trial. Ann Gen Psychiatry. 2025 Dec 4;25(1):1. doi: 10.1186/s12991-025-00607-4.
- Derived from this study: PubMed 39433921Woodham RD, Selvaraj S, Lajmi N, Hobday H, Sheehan G, Ghazi-Noori AR, Lagerberg PJ, Rizvi M, Kwon SS, Orhii P, Maislin D, Hernandez L, Machado-Vieira R, Soares JC, Young AH, Fu CHY. Home-based transcranial direct current stimulation treatment for major depressive disorder: a fully remote phase 2 randomized sham-controlled trial. Nat Med. 2025 Jan;31(1):87-95. doi: 10.1038/s41591-024-03305-y. Epub 2024 Oct 21.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation in people with Major Depressive Disorder, run by Flow Neuroscience AB at 2 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 17 inclusion and 33 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: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, United Kingdom. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HDRS-17 - Hamilton Depression Ratin Scale (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05202119, which also lists 2 linked publications.
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 22 Apr 2026.