Bipolar Depression
Conditions
Interventions
Two groups:Repetitive Transcranial Magnetic Stimulation for three weeks versus An inactive Sham coil
Sponsors
Tai Po Hospital, CUHK
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: - Right-handed - Aged 18-65 - DSM5 Bipolar I or II Disorder - Currently in DSM5 Major Depressive episode lasting for 6 weeks or more - No DSM5 manic or hypomanic episode in the past week - MADRS score more than 20 - Clinical Global Impression severity of illness scale of or more than 4 - All patients must be on lithium ( plasma levels 0.5 to 1.0 mmol/L) or sodium valproate (plasma levels more than 350mmol/L) or lamotrigine. -Showed no response (defined as lack of significant reduction of MADRS total score 25% or less compared to pre-treatment scores) to at least one adequate antidepressant trial (defined as full or best tolerated doses for at least 6 weeks; antidepressants may include bupropion or SSRI apart from paroxetine. -Currently making valid informed written consent.
Exclusion criteria
Exclusion criteria: -Organic brain syndromes -Current psychotic symptoms -Mental retardation -substance use in recent 3 months -active suicidal ideation or suicide attempt in the past month -obsessive-compulsive disorder, PTSD, eating disorders -Lack of response to adequate trial of electroconvulsive therapy -Previous rTMS treatment -Current pregnancy -Personal or known 1st-degree relatives' history of seizures -Presence of metallic implants or aneurysm clips -Unstable cardiac disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinically significant response defined as 50% reduction in MADRS from baseline and CGI equal or less than 2 at end of treatment at week 3; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of treatment-emergent DSM5;manic or hypomanic episodes from low-frequency stimulation of right DLPFC in BPI or II Depression by week 4.;Early remission rate defined as MADRS less than 7 and CGI=1 at week 3;Sustained response and remission rate at weeks 6 and 12 after treatment initiation.; | — |
Countries
China
Contacts
Public ContactDr. Mak Dun Ping, Arthur
Outcome results
None listed