Depression in Parkinson's DiseasePhase 2NCT01416818
Treatment of Depression in Parkinson's Disease
A Phase 2 study testing Xiaoyao Pill and Bupleurum+Ginkgo in people with Depression in Parkinson's Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
The goal of this study is to evaluate the efficacy of Traditional Chinese Medicine-"Xiaoyao Pill" (Herb extracts)on depression, compared to placebo and "Bupleurum+Ginkgo" in patients with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Depression in Parkinson's Disease
- What is being tested?
- Xiaoyao Pill and Bupleurum+Ginkgo
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- May 2008to Dec 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's disease without dementia
- Depression
- Males or females
- Willing and able to give informed consent
Who cannot join
- cognitive dysfunction
- other serious diseases
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital
Beijing, 100053
Piu Chan, M.D., Ph.D., +86-10-83198677, pbchan@hotmail.com
pbchan90@gmail.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of "Xiaoyao Pill" Treatment of Depression in Patients With Parkinson's Disease
The goal of this study is to evaluate the efficacy of Traditional Chinese Medicine-"Xiaoyao Pill" (Herb extracts)on depression, compared to placebo and "Bupleurum+Ginkgo" in patients with Parkinson's disease.
Read the detailed description
Depression as the most common non-motor comorbidity of Parkinson's disease (PD), have a negative impact on disability and quality of life.
Traditional Chinese Medicine has shown effects on several depression. It is not known if TCM also is effective for depression in PD. This study is to investigate "Xiaoyao Pill", an antidepressant in TCM, on depression in PD.
A total of 60 patients with depression in PD will be randomized to each of the three arms.
- Conditions
- Depression in Parkinson's Disease
- Being tested
- Xiaoyao Pill, Bupleurum+Ginkgo, placebo
- Keywords
- Depression;, Parkinson's disease;, antidepressant
- Medical subject headings
- Depression, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xiaoyao PillDrug
herb extracts,were received two times a day for 12 weeks without dose changing.
Bupleurum+GinkgoDrug
herb extracts, were received two times a day for 12 weeks without dose changing.
placeboDrug
The placebo looked like herb extracts and were also received two times a day for 12 weeks without dose changing.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | Not described Receives: Drug: Xiaoyao Pill |
| group 2 | Active comparator | Not described Receives: Drug: Bupleurum+Ginkgo |
| group 3 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Scale
Change of Hamilton Depression Scale score on week 12 from baseline.
Measured: 12 weeks
Secondary outcomes (2)
the responder rate (defined as score reduction of HAMD-17>=50%)
Measured: 12 weeks
the Geriatric Depression Scale
GDS-30
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2011 (estimated)
- Study startMay 2008
- Primary completionOct 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression in Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Investigators
- Piu Chan, MD. PhD., Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416818
- Sponsor's protocol ID
- 2008XYRCT
- Status last verified
- Aug 2011
- First submitted
- 11 Aug 2011
- Last updated
- 15 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of "Xiaoyao Pill" Treatment of Depression in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01416818
- Acronym / sponsor ID
- 2008XYRCT
- Conditions
- Depression in Parkinson's Disease
- Keywords
- Depression;, Parkinson's disease;, antidepressant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 15 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate the efficacy of Traditional Chinese Medicine-"Xiaoyao Pill" (Herb extracts)on depression, compared to placebo and "Bupleurum+Ginkgo" in patients with Parkinson's disease.
Detailed description
Depression as the most common non-motor comorbidity of Parkinson's disease (PD), have a negative impact on disability and quality of life.
Traditional Chinese Medicine has shown effects on several depression. It is not known if TCM also is effective for depression in PD. This study is to investigate "Xiaoyao Pill", an antidepressant in TCM, on depression in PD.
A total of 60 patients with depression in PD will be randomized to each of the three arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Drug: Xiaoyao Pill |
| group 2 | Active comparator | Drug: Bupleurum+Ginkgo |
| group 3 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Parkinson's disease without dementia
- Depression
- Males or females
- Willing and able to give informed consent
Key exclusion criteria (2 listed)
- cognitive dysfunction
- other serious diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xiaoyao Pillherb extracts,were received two times a day for 12 weeks without dose changing. | Drug | group 1 |
| Bupleurum+Ginkgoherb extracts, were received two times a day for 12 weeks without dose changing. | Drug | group 2 |
| placeboThe placebo looked like herb extracts and were also received two times a day for 12 weeks without dose changing. | Drug | group 3 |
Primary outcome
Hamilton Depression Scale
Time frame: 12 weeks
Change of Hamilton Depression Scale score on week 12 from baseline.
2 secondary outcomes
the responder rate (defined as score reduction of HAMD-17>=50%)
Time frame: 12 weeks
the Geriatric Depression Scale
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piu Chan, MD. PhD. principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Xiaoyao Pill and Bupleurum+Ginkgo in people with Depression in Parkinson's Disease, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinglin Zhang, MD, PhD. (+86-10-83198677, littlenumskull@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2011.