Bipolar Depression
Conditions
Brief 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. 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.
Interventions
DEVICEdeep Transcranial Magnetic Stimulation (dTMS) -active
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).
DEVICEdeep Transcranial Magnetic Stimulation (dTMS) -sham
The sham stimulation was performed using the same procedures, with the sham coil.
Sponsors
Tianjin Anding Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change over time in the score of Hamilton Depression Rating Scale (HDRS-17). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response and remission rates at weeks 2, week 4 and week 8 with HDRS-17. | weeks 2, week 4 and week 8 | The aim is to evaluate the response and remission rates at weeks 2, week 4 and week 8 with HDRS-17. |
| The change of scores in MATRICS Consensus Cognitive Battery(MCCB) | baseline, week 4, week 8 | 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. |
| The change over time in the score of Hamilton Anxiety Rating Scale (HAMA) | baseline, week 2, week 4, week 8 | 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. |
| The changes of levels of Brain Derived Neurotrophic Factor (BDNF) in peripheral blood | baseline, week 4, week 8 | 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. |
| The change of scores of adverse events scale from baseline to week 4 | baseline, week 4 | The aim is to evaluate the adverse effects during the treatment. |
Countries
China
Contacts
CONTACTJie Li, Doctor
Outcome results
None listed