CUHK_CCT00440
2014-12-04
Prospective
HMRF Ref: 12130691CREC 2014.542
Food and Health Bureau
Department of Psychiatry, The Chinese University of Hong Kong
N/A
Not Applicable
Dr. Mak Dun Ping, Arthur
Department of Psychiatry CUHK, G/F Multicentre, Tai Po Hospital, 9 Chuen On Road, Tai Po, NT, Hong Kong SAR.
852-26076024
arthurdpmak@cuhk.edu.hk
Department of Psychiatry, The Chinese University of Hong Kong
Hong Kong
Dr. Mak Dun Ping, Arthur
Department of Psychiatry CUHK, G/F Multicentre, Tai Po Hospital, 9 Chuen On Road, Tai Po, NT, Hong Kong SAR.
852-26076035
arthurdpmak@cuhk.edu.hk
Department of Psychiatry, The Chinese University of Hong Kong
Hong Kong
Randomized Sham-controlled Trial of Augmentative Neuro-Navigated Right-Dorsolateral Prefrontal Cortex Low-frequency Repetitive Transcranial Magnetic Stimulation for Antidepressant non-responding Bipolar Depression
Randomised Controlled Trial of Repetitive TMS for Bipolar Depression
定位低頻連環顱外磁激治療對抗藥性鬱躁性抑鬱症隨機對照試驗
Randomised Controlled Trial of Repetitive TMS for Bipolar Depression
Hong Kong
Yes
2014-11-04
Joint CUHK-NTEC Clinical Research Ethics Committee
2014.542
Bipolar Depression
Device
Repetitive Transcranial Magnetic Stimulation
15 sessions, each session 5 trains of sixty 1Hz stimulation given at 110% of motor threshold
15 sessions, each session 5 trains of sixty 1Hz stimulation given at 110% of motor threshold
3 weeks
15 sessions, each session 5 trains of sixty 1Hz stimulation given at 110% of motor threshold
An inactive Sham coil will be used as control intervention.
Same as active intervention except stimulation given at 0% of motor threshold
Same as active intervention except stimulation given at 0% of motor threshold
3 weeks
Same as active intervention except stimulation given at 0% of motor threshold
- 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 >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 >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
-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
18
65
Both Male and Female
Interventional
Randomized
Randomised single-blind sham controlled trial
Placebo
Single-blind
Trial subjects
Parallel
3
2015-01-15
60
Recruiting
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
- 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 <7 and CGI=1 at week 3
- Sustained response and remission rate at weeks 6 and 12 after treatment initiation.
2015-12-05
ChiCTR-IOR-14005602
2014-12-04
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