|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT01416818 |
|
Date of registration:
|
11/08/2011 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Treatment of Depression in Parkinson's Disease
|
|
Scientific title:
|
A Randomized, Double-Blind, Placebo-Controlled Study of "Xiaoyao Pill" Treatment of Depression in Patients With Parkinson's Disease |
|
Date of first enrolment:
|
May 2008 |
|
Target sample size:
|
60 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01416818 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Contacts
|
|
Name:
|
Piu Chan, MD. PhD. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Xuanwu Hospital, Beijing |
|
|
Name:
|
Piu Chan, M.D., Ph.D. |
|
Address:
|
|
|
Telephone:
|
+86-10-83198677 |
|
Email:
|
pbchan@hotmail.com |
|
Affiliation:
|
|
|
|
Name:
|
Jinglin Zhang, MD, PhD. |
|
Address:
|
|
|
Telephone:
|
+86-10-83198677 |
|
Email:
|
littlenumskull@hotmail.com |
|
Affiliation:
|
|
|
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Parkinson's disease without dementia
- Depression
- Males or females
- Willing and able to give informed consent
Exclusion Criteria:
- cognitive dysfunction
- other serious diseases
Age minimum:
30 Years
Age maximum:
80 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Depression in Parkinson's Disease
|
|
Intervention(s)
|
|
Drug: Bupleurum+Ginkgo
|
|
Drug: placebo
|
|
Drug: Xiaoyao Pill
|
|
Primary Outcome(s)
|
|
Hamilton Depression Scale
[Time Frame: 12 weeks]
|
|
Secondary Outcome(s)
|
|
the Geriatric Depression Scale
[Time Frame: 12 weeks]
|
|
the responder rate (defined as score reduction of HAMD-17>=50%)
[Time Frame: 12 weeks]
|
|
Secondary ID(s)
|
|
2008XYRCT
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|