Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00440

2 Trial Registration Date

2014-12-04

i Registration Status

Prospective

3 Secondary IDs

HMRF Ref: 12130691
CREC 2014.542

4 Source(s) of Funding

Food and Health Bureau

5 Primary Sponsor

Department of Psychiatry, The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Dr. Mak Dun Ping, Arthur

ii Address

Department of Psychiatry CUHK, G/F Multicentre, Tai Po Hospital, 9 Chuen On Road, Tai Po, NT, Hong Kong SAR.

iii Phone

852-26076024

iv Email

arthurdpmak@cuhk.edu.hk

v Affiliation

Department of Psychiatry, The Chinese University of Hong Kong

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Dr. Mak Dun Ping, Arthur

ii Address

Department of Psychiatry CUHK, G/F Multicentre, Tai Po Hospital, 9 Chuen On Road, Tai Po, NT, Hong Kong SAR.

iii Phone

852-26076035

iv Email

arthurdpmak@cuhk.edu.hk

v Affiliation

Department of Psychiatry, The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Randomized Sham-controlled Trial of Augmentative Neuro-Navigated Right-Dorsolateral Prefrontal Cortex Low-frequency Repetitive Transcranial Magnetic Stimulation for Antidepressant non-responding Bipolar Depression

10 Public Title

Randomised Controlled Trial of Repetitive TMS for Bipolar Depression

i Public Title in Chinese 研究名稱

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

11 Short Title (Optional)

Randomised Controlled Trial of Repetitive TMS for Bipolar Depression

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2014-11-04

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Bipolar Depression

15 Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

Repetitive Transcranial Magnetic Stimulation

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

3 weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

An inactive Sham coil will be used as control intervention.

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i 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 >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

ii 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

iii Age Minimum

18

iv Age Maximum

65

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Single-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2015-01-15

21 Target Sample Size

60

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

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

24 Secondary Outcome

- 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.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-12-05

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

not yet available

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Trial History Detail on 2014-12-04