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A randomized, double-blind, sham-controlled study of deep-brain magnetic stimulation (DMS) in the treatment of bipolar depression

A randomized, double-blind, sham-controlled study of deep-brain magnetic stimulation (DMS) in the treatment of bipolar depression

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-17013338
Enrollment
Unknown
Registered
2017-11-10
Start date
2017-12-01
Completion date
Unknown
Last updated
2018-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bipolar disorder

Interventions

Deep-brain magnetic stimulation:Patients in this arm will receive 14 days of active DMS, twice a day.
sham stimulation:Patients in this arm will receive 14 days of sham stimulation, twice a day.

Sponsors

Beijing Anding Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Inpatients/Out-patients, male or female, aged 18 to 60 years (including 18 years and 60 years); 2. Meet the diagnosis standard of Bipolar disorder (ICD-10), current episode depressed without psychotic features; 3. Having 17-item Hamilton Depression Rating Scale (HAMD-17) total score = 14; 4. Primary school or above education background, to be able to understand the content of the questionaire; 5. Signed informed consent by patient him/her self.

Exclusion criteria

Exclusion criteria: 1. Have been diagnosed of schizophrenia, schizoaffective disorder or other mental disorders associated with diseases; 2. Have alcohol/drug dependence or acute poisoning within 1 year; 3. Pregnant or lactating women; 4. Currently have a serious risk of suicide judged by investigators; 5. Currently have severe physical illnesses which researchers think it is risky and not eligible to participate; 6. Previously not tolerate to lithium carbonate; 7. Have been treated with lithium carbonate with daily dose of more than 0.75g and continuous use of more than 14 days before entering the study; 8. Have been treated with fluoxetine or antipsychotic long-acting injection within 30 days; 9. Currently have kidney diseases; 10. Have thyroid dysfunction or currently on hormone therapy before enrollment; 11. With history of craniocerebral injury or nervous system or repeated episodes of headache; 12. Recent history (within 1 year) of ECT or MECT treatment; 13. Have metal objects embedded in the body can not be removed, such as dentures, artery clips, pacemakers or metal fixtures, etc.

Design outcomes

Primary

MeasureTime frame
The change of HAMD-17 total score;Change of Electroencephalogram, magnetic resonance brain imaging examination;

Secondary

MeasureTime frame
response rate;Remission rate;

Countries

China

Contacts

Public ContactXiao Le

Beijing Anding Hospital, Capital Medical University

xiaole373@163.com+86 13466604224

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 25, 2026