Clinical trial NCT06524505: Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression
Official title: Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression: a Double-blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bipolar Depression
Lead sponsor: Tianjin Anding Hospital
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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% 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.

Eligibility criteria: Inclusion Criteria:

Confirmed diagnosis of bipolar depression;

* Met standardized criteria for failure to achieve remission from pharmacological treatment in the current illness episode;
* Pharmacological treatment maintained unchanged for the four weeks preceding rTMS application；
* Able to read, verbalize understanding and voluntarily sign the informed consent form prior to performance of any study-specific procedures or assessments

Exclusion Criteria:

* Previous treatment with rTMS;
* Ferromagnetic material close to the head;
* Cardiac pacemaker and/or implanted electronic device;
* The presence of neurological disorders (uncontrolled epilepsy, previous significant head injuries, brain surgery);
* Pregnancy or lactation;
* Significant medical and/or psychiatric comorbidities;
* Substance abuse in the last three months (not including caffeine or nicotine);
* Acute psychosis;
* Acute suicidality;
* Patient refuses to sign consent for participation in the study

Primary outcomes:
measure: The change over time in the score of Hamilton Depression Rating Scale (HDRS-17).
timeFrame: baseline, week 2, week 4, week 8
Secondary outcomes:
measure: The change over time in the score of Hamilton Anxiety Rating Scale (HAMA)
timeFrame: baseline, week 2, week 4, week 8
measure: The change of scores in MATRICS Consensus Cognitive Battery(MCCB)
timeFrame: baseline, week 4, week 8
measure: The changes of levels of Brain Derived Neurotrophic Factor in peripheral blood
timeFrame: baseline, week 4, week 8
measure: The change of scores of Adverse events scale from baseline to week 4
timeFrame: baseline, week 4
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Anding Hospital
Study officials:
References: