Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00466

2 Trial Registration Date

2015-08-05

i Registration Status

Prospective

3 Secondary IDs

2015.264

4 Source(s) of Funding

Department of Psychiatry, CUHK

5 Primary Sponsor

Department of Psychiatry, CUHK

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Dr Hiu-Ha Lam

ii Address

Department of Psychiatry, Tai Po Hospital

iii Phone

26076111

iv Email

lhh762@ha.org.hk

v Affiliation

Department of Psychiatry, Tai Po Hospital

vi Country

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

i Name

Dr Hiu-Ha Lam

ii Address

Department of Psychiatry, Tai Po Hospital

iii Phone

26076111

iv Email

lhh762@ha.org.hk

v Affiliation

Department of Psychiatry, Tai Po Hospital

vi Country

9 Official Scientific Title of the Study

A Randomized Controlled Trial on Effects of Transcranial Direct Current Stimulation (tDCS) on Cognitive Function of Schizophrenia Patients

10 Public Title

A Randomized Controlled Trial on Effects of Transcranial Direct Current Stimulation (tDCS) on Cognitive Function of Schizophrenia Patients

i Public Title in Chinese 研究名稱

腦部輕微電流刺激對改善精神分裂症認知功能的研究

11 Short Title (Optional)

tDCS for Schiz

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?

2015-07-17

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Schizophrenia

15 Intervention

i Types of intervention

Procedure

Please specify

ii Description/ name of Intervention/article

Transcranial Direct Current Stimulation (tDCS)

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

4 weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Sham tDCS for 4 weeks

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

(a) Psychiatric Day Hospital attendees aged between 18-64 years old, (b) diagnosis of schizophrenia meeting the diagnostic criteria of the World Health Organization’s 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10), as confirmed from the case notes, (c) right-handedness, (d) able to understand spoken instruction in Cantonese and read written traditional Chinese

ii Exclusion Criteria

(a) documented history of mental retardation, (b) concurrent substance abuse, (c) concurrent use of cognitive-enhancing medications e.g. acetylcholinesterase inhibitors, (d) unstable medical or neurological conditions, (e) pregnancy

iii Age Minimum

18

iv Age Maximum

64

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

Double-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

2015-08-31

21 Target Sample Size

46

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Forward Digit Span, Backward Digit Span at 0/ 4/ 8 weeks

24 Secondary Outcome

Block Spatial Span, Verbal Fluency, TMT A&B, PANSS, HAM-D at 0/ 4/ 8 weeks

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2016-04-05

27 Primary Registry and Trial Identifying Number

ChiCTR-IOR-15006882

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

N/A

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Trial History Detail on 2015-08-11