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Completed

NCT Number: NCT05436613

Transcranial Direct Current Stimulation Therapy for Bipolar Depression

Bipolar disorder is a severe and disabling disorder. The course of illness is often progressive but is highly heterogeneous between individuals and within the lifetime for an individual. The most common treatments are medications. However, for many individuals, combinations of medications are often required, and full recovery is infrequent.

The novel brain stimulation treatment, transcranial direct current stimulation (tDCS), is a potential first-line treatment for bipolar depression. The present research question is whether tDCS can be provided as a home-based treatment for bipolar depression for adults with bipolar disorder.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of East London

London, E16 2RD, United Kingdom

About this study

The novel brain stimulation treatment, transcranial direct current stimulation (tDCS), is a potential first-line treatment for bipolar disorder. tDCS generates a small electric current which modulates how easy it is for active brain cells to discharge. The device is a headband worn over the forehead with two electrodes, which are small metal discs, where the current comes from. tDCS does not directly stimulate brain cells to cause a seizure like electroconvulsive therapy (ECT) and it does not induce brain cells to discharge like transcranial magnetic stimulation (TMS).

Clinical studies have shown that tDCS treatment could help to improve the symptoms of depression. The main side effects have been redness, skin irritation or sensations (itching, tingling or burning) under the electrodes. Less commonly reported side effects include headache or tiredness. tDCS is a portable and safe treatment.

The studies to date have mostly looked at tDCS treatment which has been provided in a research setting. This is a problem because the treatment requires daily sessions for several weeks which could limit whether individuals would be able to go every day. As tDCS is a portable and safe treatment, it could be provided in the community.

The present study is a proof-of-concept trial to assess the efficacy, acceptability and safety of tDCS treatment for bipolar depression within a community-based setting.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis of bipolar disorder based on DSM-5 criteria
  • minimum score of 18 on the MADRS
  • being on a stable dosage of mood stabilizing medication for a minimum of two weeks

Exclusion criteria

  • comorbid psychiatric disorder
  • significant risk of suicide or self harm
  • any contraindications to tDCS, including implanted electronic medical devices
  • history of epilepsy

Treatment and study plan

Transcranial Direct Current Stimulation

Device

tDCS at 2mA in 30 minute sessions for 5 sessions per week for 3 weeks and then 2 sessions per week for 3 weeks.

Primary outcomes

  1. Number of Participants With Clinical Response [ Time Frame: At 6 Weeks Following Course of tDCS Treatment ]

    Time frame: 6 weeks

    As measured by clinician-rated Montgomery Asberg Depression Rating Scale (MADRS) score improvement of 50% or more from baseline following the course of tDCS treatment.

Secondary outcomes

  1. Participant Retention at the End of the Treatment

    Time frame: 6 weeks (visit 21)

    The number of participants who have completed a minimum of 15 tDCS sessions

  2. Participant Acceptability Questionnaire Scales

    Time frame: Week 6 (Visit 21)

    Participants were asked how acceptable they found the tDCS treatment after the 6-week course of treatment. They were given responses on a 7-point Likert style scale. The number of participants who rated the tDCS treatment as acceptable on the Treatment Acceptability Questionnaire (Likert responses 5, 6 or 7) are reported.

Other outcomes

  1. MADRS Remission Rate

    Time frame: 6 weeks (Visit 21)

    Trained rater measure of depressive symptoms: Montgomery-Åsberg Depression Rating Scale (MADRS) remission rate: a score of less than 10 following the course of tDCS

Sponsors and collaborators

Lead sponsor

University of East London

Other

Collaborators

  • King's College London
  • Technische Universität Dresden
  • University College, London

Registry information

Official study title

Community-based Transcranial Direct Current Stimulation Treatment for Bipolar Depression

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 29, 2022
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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