Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00169

2 Trial Registration Date

2008-10-14

i Registration Status

Prospective

3 Secondary IDs

nil

4 Source(s) of Funding

Direct grant (faculty of medicine)

5 Primary Sponsor

Nil

6 Secondary Sponsor

Nil

Function

Please specify

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

i Name

Lee Chui Ping

ii Address

Rm 622B, 6/F, Li Choh Ming BMSB, CUHK

iii Phone

26096819

iv Email

cplee@cuhk.edu.hk

v Affiliation

School of Pharmacy, CUHK

vi Country

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

i Name

Lee Chui Ping

ii Address

Rm 622B, 6/F, Li Choh Ming BMSB, CUHK

iii Phone

26096819

iv Email

cplee@cuhk.edu.hk

v Affiliation

School of Pharmacy, CUHK

vi Country

9 Official Scientific Title of the Study

Impact of an Interdisciplinary Approach on Symptom Management of Newly Diagnosed Depressive Patients

10 Public Title

Impact of an Interdisciplinary Approach on Symptom Management of Newly Diagnosed Depressive Patients

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

nil

12 Countries of Recruitment

Hong Kong, China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2008-07-04

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Depression

15 Intervention

i Types of intervention

Other

Please specify

patient education

ii Description/ name of Intervention/article

Pharmacist education

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

6 months

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Patients in control group will be provided with one educational leaflet in the initial visit (i.e. the same educational leaflet received by patients in IG) and will receive usual care in the outpatient psychiatry clinic. A trained, non-pharmacist personnel will meet with the patient to provide contact time comparable to that of the patients in the intervention group.

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

Adult patients, who are newly diagnosed with depressive disorders, able to communicate in Cantonese or English, have no previous exposure (within the past six months) to any antidepressants, and will start a treatment with an antidepressant, will be included.

ii Exclusion Criteria

Exclusion: have dementia or any kinds of significant cognitive impairment, hearing impairment, terminal illnesses, psychosis, bipolar disorder, history of alcohol or any kinds of substance abuse, 2. have high suicidal risks, and 3. are pregnant or nursing, illiterate, taking St John's Wort or any other Traditional Chinese Medicines (TCM) for depression

iii Age Minimum

18

iv Age Maximum

80

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

Open label

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

2008-10-20

21 Target Sample Size

135

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

The proportion of patients with at least 50% improvement in the Chinese version of 13-item Beck Depression Inventory (BDI) score Percentage of patients with Hamilton Depression score (HAM-D) < or =7

24 Secondary Outcome

The average change in BDI score at 6-month compared to that in baseline The improvement in health-related quality of life assessed by The Chinese (Hong Kong) SF-36 at baseline and 6-month The baseline and 6-month Clinical Global Impression-Severity of Illness (CGI-S) and Improvement (CGI-I) scales Percentage of patients who compliant with antidepressant treatment at 3- and 6-month. Patients who consumed >80% of pills dispensed during the prescribed period will be categorized as compliant with antidepressant treatment Cost-utility analyses to estimate the ratio between the cost of intervention and the potentialbenefit in symptom improvement observed

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2012-06-28

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-09000726

28 Date of Registration in Primary Registry

2010-05-04

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

nil

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Trial History Detail on 2011-02-08