Bipolar DepressionNCT06524505
Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression
A study testing deep Transcranial Magnetic Stimulation (dTMS) -active in people with Bipolar Depression, run by Tianjin Anding Hospital at 1 site in China.
Trial summary
The aim of this study is to evaluate the feasibility and efficacy of deep transcranial magnetic stimulation (dTMS) as an add-on treatment for bipolar depression. Meanwhile, we aim to evaluate the effect of dTMS on cognitive function of bipolar depressive patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Depression
- What is being tested?
- deep Transcranial Magnetic Stimulation (dTMS) -active
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of bipolar depression;
- age between 18 and 65 years;
- a 17-item Hamilton Depression Rating Scale (HDRS-17) score >= 17,
- a stable pharmacological regimen maintained for at least 4 weeks prior to the beginning of the treatment phase ;
- for participants who had previously received antidepressant therapy, a minimum 4-week washout period followed by re-evaluation.
Who cannot join
- a lifetime history of other psychiatric disorders, neurological diseases, or severe brain injury;
- receipt of electroconvulsive therapy, rTMS, transcranial direct current stimulation, transcranial alternating current stimulation, or other neurostimulation treatments within the previous 3 months;
- contraindications to magnetic stimulation, including epilepsy, cardiovascular disorders, or metallic implants in the head;
- the presence of hypomanic/manic symptoms at baseline or a score greater than 12 on the Young Mania Rating Scale (YMRS);
- pregnancy or lactation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Anding Hospital
Tianjin
Jie Li, Doctor, +86 022 88188006, jieli@tjmhc.com
About this study
Official title: Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression: a Double-blind, Randomized Controlled Trial
The aim of this study is to evaluate the feasibility and efficacy of deep transcranial magnetic stimulation (dTMS) as an add-on treatment for bipolar depression. Meanwhile, we aim to evaluate the effect of dTMS on cognitive function of bipolar depressive patients. We hypothesize dTMS would improve depressive symptoms and cognitive function in bipolar disorder.
Read the detailed description
This is a randomized, double-blind, sham-controlled study to detect the effect of dTMS for treatment of bipolar depression. 100 participants were randomly assigned 1:1 to dTMS group or sham-control group. For both active and sham group, daily dTMS sessions were scheduled in a 5-day sequence for four consecutive weeks, and each session lasted 20minutes. Based on the original and stable medication, the active stimulation consisted of 55 18 Hz, 2 s trains at 120% motor threshold (MT) intensity, with a between-train interval of 20 s (1980 pulses per day or 39 600 pulses per treatment). The sham stimulation was performed using the same procedures, with the sham coil.
Scale assessments are performed at baseline, week 2, week 4 and week 8. Collection of blood took place at baseline, week 4 and week 8.
- Conditions
- Bipolar Depression
- Being tested
- deep Transcranial Magnetic Stimulation (dTMS) -active, deep Transcranial Magnetic Stimulation (dTMS) -sham
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep Transcranial Magnetic Stimulation (dTMS) -activeDevice
with the H1-coil device included 20-min sessions of 18 Hz (2-s trains separated by 20-s inter-train intervals, 55 trains totaling 1980 pulses/session).
deep Transcranial Magnetic Stimulation (dTMS) -shamDevice
The sham stimulation was performed using the same procedures, with the sham coil.
| Study group | Role | What they receive |
|---|---|---|
| dTMS group | Experimental | Participants receive active stimulation with H1 coil, consisting of 55 18 Hz, 2 s trains at 120% MT intensity, with a between-train interval of 20 s ,1980 pulses per day. The subjects were stimulated every day for 4 weeks (except weekends). Receives: Device: deep Transcranial Magnetic Stimulation (dTMS) -active |
| sham group | Sham comparator | The sham stimulation was performed using the same procedures, with the sham coil. Receives: Device: deep Transcranial Magnetic Stimulation (dTMS) -sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change over time in the score of Hamilton Depression Rating Scale (HDRS-17).
The aim is to explore whether deep Transcranial Magnetic Stimulation (dTMS) combined with Pharmacological treatment could alleviate the severity of depressive symptoms as measured with HDRS-17 in bipolar depression after 4-week treatment. Hamilton Depression Rating Scale (HDRS-17) was used to evaluate the severity of symptoms of depression. Higher total score of the scale means more severe depressive symptoms.
Measured: baseline, week 2, week 4, week 8
Secondary outcomes (5)
Response and remission rates at weeks 2, week 4 and week 8 with HDRS-17.
The aim is to evaluate the response and remission rates at weeks 2, week 4 and week 8 with HDRS-17.
Measured: weeks 2, week 4 and week 8
The change of scores in MATRICS Consensus Cognitive Battery(MCCB)
The aim is to observe whether active-stimuli in addition to pharmacological treatment will improve the cognitive function as measured with the MATRICS Consensus Cognitive Battery (MCCB) after 4 weeks of treatment compared to sham-stimuli, and investigators assess the scale at baseline, week 4 and week 8.
Measured: baseline, week 4, week 8
The change over time in the score of Hamilton Anxiety Rating Scale (HAMA)
The aim is to explore whether dTMS combined with Pharmacological treatment could alleviate the severity of anxious symptoms as measured with HAMA in bipolar depression after 4-week treatment. Hamilton Anxiety Rating Scale (HAMA) was used to evaluate the severity of symptoms of anxiety. Higher total score of the scale means more severe anxious symptoms.
Measured: baseline, week 2, week 4, week 8
The changes of levels of Brain Derived Neurotrophic Factor (BDNF) in peripheral blood
The aim is to investigate the change of Brain Derived Neurotrophic Factor (BDNF) level in peripheral blood as active stimuli in addition to regular medical treatment after 4 weeks of treatment compared to sham stimuli, and EDTA tubes were used to collect 5ml of peripheral blood at baseline, weeks 4, and 8 before feeding. The plasma was extracted after centrifugation, and the concentration of BDNF in plasma was detected by ELISA.
Measured: baseline, week 4, week 8
The change of scores of adverse events scale from baseline to week 4
The aim is to evaluate the adverse effects during the treatment.
Measured: baseline, week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Aug 2024
- Primary completion1 Sep 2025
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DepressionStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Anding Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524505
- Sponsor's protocol ID
- dTMS-TJAH
- Status last verified
- Feb 2026
- First submitted
- 23 Jul 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chu L, Jia X, Gao P, Sun X, Zhang J, Ding Y, Chen S, Bi F, Zhang C, Li D, Zhang Y. Effects of Deep Transcranial Magnetic Stimulation on Cognitive Function in Bipolar Depression: A Randomized Controlled Trial Using the MATRICS Consensus Cognitive Battery. Alpha Psychiatry. 2026 Feb 28;27(1):47409. doi: 10.31083/AP47409. eCollection 2026 Feb.
PubMed 41788133
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression: a Double-blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06524505
- Acronym / sponsor ID
- dTMS-TJAH
- Conditions
- Bipolar Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tianjin Anding HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- Feb 2026 (estimated)
- First posted
- 29 Jul 2024 (actual)
- 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 of this study is to evaluate the feasibility and efficacy of deep transcranial magnetic stimulation (dTMS) as an add-on treatment for bipolar depression. Meanwhile, we aim to evaluate the effect of dTMS on cognitive function of bipolar depressive patients. We hypothesize dTMS would improve depressive symptoms and cognitive function in bipolar disorder.
Detailed description
This is a randomized, double-blind, sham-controlled study to detect the effect of dTMS for treatment of bipolar depression. 100 participants were randomly assigned 1:1 to dTMS group or sham-control group. For both active and sham group, daily dTMS sessions were scheduled in a 5-day sequence for four consecutive weeks, and each session lasted 20minutes. Based on the original and stable medication, the active stimulation consisted of 55 18 Hz, 2 s trains at 120% motor threshold (MT) intensity, with a between-train interval of 20 s (1980 pulses per day or 39 600 pulses per treatment). The sham stimulation was performed using the same procedures, with the sham coil.
Scale assessments are performed at baseline, week 2, week 4 and week 8. Collection of blood took place at baseline, week 4 and week 8.
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 |
|---|---|---|
| dTMS group | Experimental | Device: deep Transcranial Magnetic Stimulation (dTMS) -activeParticipants receive active stimulation with H1 coil, consisting of 55 18 Hz, 2 s trains at 120% MT intensity, with a between-train interval of 20 s ,1980 pulses per day. The subjects were stimulated every day for 4 weeks (except weekends). |
| sham group | Sham comparator | Device: deep Transcranial Magnetic Stimulation (dTMS) -shamThe sham stimulation was performed using the same procedures, with the sham coil. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of bipolar depression;
- age between 18 and 65 years;
- a 17-item Hamilton Depression Rating Scale (HDRS-17) score >= 17,
- a stable pharmacological regimen maintained for at least 4 weeks prior to the beginning of the treatment phase ;
- for participants who had previously received antidepressant therapy, a minimum 4-week washout period followed by re-evaluation.
Key exclusion criteria (5 listed)
- a lifetime history of other psychiatric disorders, neurological diseases, or severe brain injury;
- receipt of electroconvulsive therapy, rTMS, transcranial direct current stimulation, transcranial alternating current stimulation, or other neurostimulation treatments within the previous 3 months;
- contraindications to magnetic stimulation, including epilepsy, cardiovascular disorders, or metallic implants in the head;
- the presence of hypomanic/manic symptoms at baseline or a score greater than 12 on the Young Mania Rating Scale (YMRS);
- pregnancy or lactation.
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 |
|---|---|---|
| deep Transcranial Magnetic Stimulation (dTMS) -activewith the H1-coil device included 20-min sessions of 18 Hz (2-s trains separated by 20-s inter-train intervals, 55 trains totaling 1980 pulses/session). | Device | dTMS group |
| deep Transcranial Magnetic Stimulation (dTMS) -shamThe sham stimulation was performed using the same procedures, with the sham coil. | Device | sham group |
Primary outcome
The change over time in the score of Hamilton Depression Rating Scale (HDRS-17).
Time frame: baseline, week 2, week 4, week 8
The aim is to explore whether deep Transcranial Magnetic Stimulation (dTMS) combined with Pharmacological treatment could alleviate the severity of depressive symptoms as measured with HDRS-17 in bipolar depression after 4-week treatment. Hamilton Depression Rating Scale (HDRS-17) was used to evaluate the severity of symptoms of depression. Higher total score of the scale means more severe depressive symptoms.
5 secondary outcomes
Response and remission rates at weeks 2, week 4 and week 8 with HDRS-17.
Time frame: weeks 2, week 4 and week 8
The change of scores in MATRICS Consensus Cognitive Battery(MCCB)
Time frame: baseline, week 4, week 8
The change over time in the score of Hamilton Anxiety Rating Scale (HAMA)
Time frame: baseline, week 2, week 4, week 8
The changes of levels of Brain Derived Neurotrophic Factor (BDNF) in peripheral blood
Time frame: baseline, week 4, week 8
The change of scores of adverse events scale from baseline to week 4
Time frame: baseline, week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Derived from this study: PubMed 41788133Chu L, Jia X, Gao P, Sun X, Zhang J, Ding Y, Chen S, Bi F, Zhang C, Li D, Zhang Y. Effects of Deep Transcranial Magnetic Stimulation on Cognitive Function in Bipolar Depression: A Randomized Controlled Trial Using the MATRICS Consensus Cognitive Battery. Alpha Psychiatry. 2026 Feb 28;27(1):47409. doi: 10.31083/AP47409. eCollection 2026 Feb.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing deep Transcranial Magnetic Stimulation (dTMS) -active in people with Bipolar Depression, run by Tianjin Anding Hospital at 1 site in China.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Li, Doctor (+86 022 88188006, jieli@tjmhc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change over time in the score of Hamilton Depression Rating Scale (HDRS-17). (time frame: baseline, week 2, week 4, week 8). 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 NCT06524505, which also lists 1 linked publication.
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 27 Feb 2026.