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Trial History Detail on 2014-12-04

CUHK_CCT00440

2014-12-04

Prospective

HMRF Ref: 12130691
CREC 2014.542

Food and Health Bureau

Department of Psychiatry, The Chinese University of Hong Kong

N/A

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

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

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

Bipolar Depression

Device

Repetitive Transcranial Magnetic Stimulation

3 weeks

An inactive Sham coil will be used as control intervention.

- 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

Placebo

Single-blind

Parallel

2015-01-15

60

Not Yet 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.

No

2015-12-05

ChiCTR-IOR-14005602 

2014-12-04


Yes

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