Antidepressive AgentsPhase 4NCT03195231
Wuling Powder for the Treatment and Underlying Mechanism of Depressive Symptoms in Patients With Parkinson's Disease
A Phase 4 study testing Wuling Powder in people with Antidepressive Agents, run by Beijing Hospital.
Trial summary
Depression is one of the most important nonmotor features of idiopathic PD（Parkinson's disease ）which may not just interfere with the motor symptoms of PD but can also cause immense personal suffering as well as decreased quality of life with increased disability and caregiver burden. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Antidepressive Agents
- What is being tested?
- Wuling Powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 25 Jun 2017to 15 Jan 2020
- Phase
- Phase 4
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic Parkinson's disease according to the 2015 MDS（Movement Disorder Society）-PD criterion
- Hoehn-Yahr stage: 1-3
- Under steady therapy of antiparkinsonian drugs for at least 28 days
- HAMD≥13
- MMSE（Mini-Mental State Examination）≥24
- Neither use antidepressant drugs nor antipsychotic drugs within 4 weeks
- Signed informed consent
Who cannot join
- Have other psychotic symptoms
- Suicide ideation or behavior
- Severe cognitive impairment，chronic organs failure，malignant tumors
- Glutamic-pyruvic transaminase or glutamic oxalacetic transaminase≥1.5 times of the high normal range or white blood cell<4*10^9/L or serum creatinine>84umol/L
- Pregnancy or lactation period
- Participant in other trials or have taken other experimental drugs within 90 days
- Allergic to fungal food or fungal drugs
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Wuling Powder for the Treatment and Underlying Mechanism of Depressive Symptoms in Patients With Parkinson's Disease: a Randomised, Double-blind, Placebo-controlled Trial.
Depression is one of the most important nonmotor features of idiopathic PD（Parkinson's disease ）which may not just interfere with the motor symptoms of PD but can also cause immense personal suffering as well as decreased quality of life with increased disability and caregiver burden. However,there is little hard evidence to guide clinical treatment. Although some newer dopamine agonists also have antidepressive effect, the use of tricyclic or nontricyclic antidepressants is frequently required.However, the side-effects of these agents may also worsen some preexisting nonmotor problems in PD. Wuling powder is a Chinese medicine which is made by cultivating Xylariasp mycelium using submerged fermentation technology. Xylariasp is the fungus sclerotia which grow in termite nests. Wuling powder is mainly used to soothe nerves and anti-insomnia in clinical. The antidepressant effect of Wuling powder has been confirmed in clinical, but not in the patients of Parkinson's disease. Therefore, the investigators design a randomized, double-blind, placebo-controlled study to evaluate the antidepressant effect of Wuling powder in PD patients and its underlying mechanism.
- Conditions
- Antidepressive Agents
- Being tested
- Wuling Powder, Placebo
- Keywords
- Parkinson's disease, Depression, Wuling Powder
- Medical subject headings
- Parkinson Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wuling PowderDrug
Patients of Wuling Group are instructed to take Wuling Powder 3 times a day and 3 pills each time for 12 weeks.
PlaceboDrug
Patients of Placebo Group are instructed to take placebo drug 3 times a day and 3 pills each time for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Wuling Powder Group | Experimental | Take Wuling Powder 3 times a day，3 pills each time for 12 weeks Receives: Drug: Wuling Powder |
| Placebo Group | Placebo comparator | Take placebo drug which cannot be distinguished from the experimental drug 3 times a day，3 pills each time for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of depression from baseline to 12 weeks
the change of depression from baseline to 12 weeks,as assessed with the use of HAMD（Hamilton Depression Scale）
Measured: 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start25 Jun 2017 (estimated)
- Primary completion15 Dec 2019 (estimated)
- Study completion15 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antidepressive AgentsStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital
- Sponsor type
- Other government
- Collaborators
- Tongji Hospital, Shanghai Tong Ren Hospital, The First Hospital of Hebei Medical University
- Responsible party
- Principal investigator, Wen Su, Beijing Hospital
- Investigators
- Wen Su, Principal investigator, Beijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195231
- Sponsor's protocol ID
- 121-2016009
- Status last verified
- Jun 2017
- First submitted
- 20 Jun 2017
- Last updated
- 22 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wuling Powder for the Treatment and Underlying Mechanism of Depressive Symptoms in Patients With Parkinson's Disease: a Randomised, Double-blind, Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT03195231
- Acronym / sponsor ID
- 121-2016009
- Conditions
- Antidepressive Agents
- Keywords
- Parkinson's disease, Depression, Wuling Powder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Beijing HospitalOther government
- Collaborators
- Tongji Hospital, Shanghai Tong Ren Hospital, The First Hospital of Hebei Medical University
- Study start
- 25 Jun 2017 (estimated)
- Primary completion
- 15 Dec 2019 (estimated)
- Study completion
- 15 Jan 2020 (estimated)
- First posted
- 22 Jun 2017 (actual)
- 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.
Depression is one of the most important nonmotor features of idiopathic PD（Parkinson's disease ）which may not just interfere with the motor symptoms of PD but can also cause immense personal suffering as well as decreased quality of life with increased disability and caregiver burden. However,there is little hard evidence to guide clinical treatment. Although some newer dopamine agonists also have antidepressive effect, the use of tricyclic or nontricyclic antidepressants is frequently required.However, the side-effects of these agents may also worsen some preexisting nonmotor problems in PD. Wuling powder is a Chinese medicine which is made by cultivating Xylariasp mycelium using submerged fermentation technology. Xylariasp is the fungus sclerotia which grow in termite nests. Wuling powder is mainly used to soothe nerves and anti-insomnia in clinical. The antidepressant effect of Wuling powder has been confirmed in clinical, but not in the patients of Parkinson's disease. Therefore, the investigators design a randomized, double-blind, placebo-controlled study to evaluate the antidepressant effect of Wuling powder in PD patients and its underlying mechanism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wuling Powder Group | Experimental | Drug: Wuling PowderTake Wuling Powder 3 times a day，3 pills each time for 12 weeks |
| Placebo Group | Placebo comparator | Drug: PlaceboTake placebo drug which cannot be distinguished from the experimental drug 3 times a day，3 pills each time for 12 weeks |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of idiopathic Parkinson's disease according to the 2015 MDS（Movement Disorder Society）-PD criterion
- Hoehn-Yahr stage: 1-3
- Under steady therapy of antiparkinsonian drugs for at least 28 days
- HAMD≥13
- MMSE（Mini-Mental State Examination）≥24
Key exclusion criteria (7 listed)
- Have other psychotic symptoms
- Suicide ideation or behavior
- Severe cognitive impairment，chronic organs failure，malignant tumors
- Glutamic-pyruvic transaminase or glutamic oxalacetic transaminase≥1.5 times of the high normal range or white blood cell<4*10^9/L or serum creatinine>84umol/L
- Pregnancy or lactation period
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 |
|---|---|---|
| Wuling PowderPatients of Wuling Group are instructed to take Wuling Powder 3 times a day and 3 pills each time for 12 weeks. | Drug | Wuling Powder Group |
| PlaceboPatients of Placebo Group are instructed to take placebo drug 3 times a day and 3 pills each time for 12 weeks. | Drug | Placebo Group |
Primary outcome
the change of depression from baseline to 12 weeks
Time frame: 12 weeks after treatment
the change of depression from baseline to 12 weeks,as assessed with the use of HAMD（Hamilton Depression Scale）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
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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.
Wen Su principal investigator
Beijing Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Wuling Powder in people with Antidepressive Agents, run by Beijing Hospital.
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 7 inclusion and 7 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 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Xin Wang (+8613661174001, wangxinannie@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of depression from baseline to 12 weeks (time frame: 12 weeks after treatment). 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 22 Jun 2017.