Major Depressive Disorder (MDD)Phase 2NCT02380066
Comparison of Anyu Peibo With Placebo in Treatment of MDD
A Phase 2 study testing Anyu Peibo in people with Major Depressive Disorder (MDD), run by Shanghai Mental Health Center at 6 sites in China.
Trial summary
The purpose of this study is to determine whether Anyu Peibo Capsule in different doses are effective in the treatment of Depression. And to explore the preliminary information of safety and efficacy of Anyu Peibo Capsule in the Chinese Patients with Depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Anyu Peibo
- 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
- 6 sitesChina
- Study dates
- Mar 2015to Jan 2017
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult with primary diagnosis of major depressive disorder(MDD) based on the criteria of DSM-IV-TR, single episode or recurrent episode, not accompanied with psychotic symptoms. Coding of diagnosis included: 296.21 MDD single episode, mild 296.22 MDD single episode, moderate 296.31 MDD recurrent episode, mild 296.32 MDD recurrent episode, moderate
- The total score of HAMD-17 is ≥18 and ≤24 in both screening visit and baseline visit.
- The subject understands and consents to takes part in this clinical trials. The subjects should sign informed consent.
Who cannot join
- The subject has a significant risk of suicide according to the investigator's opinion or has a score ≥3 on item 3(suicide assessment) of the HAMD or has made a suicide attempt.
- The subject has a current DSM-Ⅳ-TR axisⅠpsychiatric diagnosis other than depression.
- When the HAMD17 score of baseline visit compares with the screening visit, the decreasing rate is ≥25%.
- Any unstable cardiovascular, hepatic, renal, endocrine(thyroid gland dysfunction), blood,or other medical disease.
- Had a history of seizure disorder,except infantile febrile convulsion.
- The subject has accepted psychosurgery or electroconvulsive therapy within 3months.
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- With psychotic symptoms.
- The subject has a history of mania episode, including manic, mixed or rapid cycle attack.
- The subject has a current diagnosis or history of depression due to any other psychotic disorder or a general medical condition.
- The subject with refractory depressive disorder,i.e.the patients who used at least two different mechanisms antidepressants with adequate dosage and duration treatment still had no respond.
- Clinically significant electrocardiographic(ECG) abnormalities or abnormal laboratory values(eg. Hepatic function above 1.5 times of clinical toplimit, renal function or thyroid gland function index above toplimit, routine blood, fasting blood glucose value above or below 1.1 times of the upper limit of normal or in 1.1 times with the clinical significance of abnormality).
- The subject has a diagnosis of alcohol or other substance abuse or dependence at least 1 years prior to the baseline visit.
- Known hypersensitivity to Big Leaf Ju, or at least to two kinds of drugs, or serious allergic physique.
- Women who were pregnant, breast-feeding, or planning to become pregnant during study. Men who have request to fertility during study period. The subject could not take safe and effective birth control measures.
- The subject could not take medication according to the doctor's advice. i.e. the compliance of the subject is poor.
- The subject uses antidepressant drug normally before 2 weeks of screening, and stops using psychotropic drug less than 7 half-life period (monoamine oxidase inhibitor more than 2 weeks, fluoxetine more than 1 month).
- The subject has participated in a drug clinical trial within 1 month before screening.
- The investigator think the subject is unsuitable to enrol in this clinical trial.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Guang'anmen Hospital
Beijing, Beijing Municipality, 100053
Peking University Sixth Hospital
Beijing, Beijing Municipality, 100191
Guangzhou Huiai Hospital
Guangzhou, Guangdong, 510370
Anhui province hospital of TCM
Hefei, Anhui, 230031
Jiangsu province hospital of TCM
Nanjing, Jiangsu, 210029
Wuxi Mental Health Center
Wuxi, Jiangsu, 214151
About this study
Official title: Proof Of Concept Study of Anyu Peibo in the Treatment of Major Depressive Disorder(MDD): a Randomized, Double-Blind, Placebo-Paralleled,Dose-Finding, Multicenter Clinical Trial
The purpose of this study is to determine whether Anyu Peibo Capsule in different doses are effective in the treatment of Depression.
And to explore the preliminary information of safety and efficacy of Anyu Peibo Capsule in the Chinese Patients with Depression.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Anyu Peibo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anyu PeiboDrug
Also called Placebo
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Anyu Peibo 0.4g per day | Experimental | Anyu Peibo Capsule, oral, 0.2g twice per day Receives: Drug: Anyu Peibo |
| Anyu Peibo 0.8g per day | Experimental | Anyu Peibo Capsule, oral, 0.4g twice per day Receives: Drug: Anyu Peibo |
| Anyu Peibo 1.2g per day | Experimental | Anyu Peibo Capsule, oral, 0.6g twice per day Receives: Drug: Anyu Peibo |
| Anyu Peibo 1.6g per day | Experimental | Anyu Peibo Capsule, oral, 0.8g twice per day Receives: Drug: Anyu Peibo |
| Placebo | Placebo comparator | Placebo,oral, twice per day Receives: Drug: Anyu Peibo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of total score from baseline in MADRS scale
Measured: 6 weeks
Secondary outcomes (8)
clinical response rate according to MADRS
Measured: 6 weeks
clinical remission rate according to MADRS
Measured: 6 weeks
CGI(CGI-S,CGI-I)
Measured: 6 weeks
The change of total score from baseline in HAMD scale
Measured: 6 weeks
decreasing rate from baseline in HAMD scale
Measured: 6 weeks
clinical response rate according to HAMD
Measured: 6 weeks
clinical remission rate according to HAMD
Measured: 6 weeks
change from baseline in HAMA
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Su Zhou YiHua Biotechnology Co. LTD
- Responsible party
- Sponsor
- Investigators
- Huafang LI, MD PhD, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380066
- Sponsor's protocol ID
- AYPB-MDD-Ⅱa-1401
- Other IDs
- 2012ZX09303-003
- Status last verified
- Mar 2015
- First submitted
- 13 Feb 2015
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof Of Concept Study of Anyu Peibo in the Treatment of Major Depressive Disorder(MDD): a Randomized, Double-Blind, Placebo-Paralleled,Dose-Finding, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT02380066
- Acronym / sponsor ID
- AYPB-MDD-Ⅱa-1401
- Conditions
- Major Depressive Disorder (MDD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Su Zhou YiHua Biotechnology Co. LTD
- Study start
- Mar 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 5 Mar 2015 (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 purpose of this study is to determine whether Anyu Peibo Capsule in different doses are effective in the treatment of Depression.
And to explore the preliminary information of safety and efficacy of Anyu Peibo Capsule in the Chinese Patients with Depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Anyu Peibo 0.4g per day | Experimental | Drug: Anyu PeiboAnyu Peibo Capsule, oral, 0.2g twice per day |
| Anyu Peibo 0.8g per day | Experimental | Drug: Anyu PeiboAnyu Peibo Capsule, oral, 0.4g twice per day |
| Anyu Peibo 1.2g per day | Experimental | Drug: Anyu PeiboAnyu Peibo Capsule, oral, 0.6g twice per day |
| Anyu Peibo 1.6g per day | Experimental | Drug: Anyu PeiboAnyu Peibo Capsule, oral, 0.8g twice per day |
| Placebo | Placebo comparator | Drug: Anyu PeiboPlacebo,oral, twice per day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult with primary diagnosis of major depressive disorder(MDD) based on the criteria of DSM-IV-TR, single episode or recurrent episode, not accompanied with psychotic symptoms. Coding of diagnosis included: 296.21 MDD single episode, mild 296.22 MDD single episode, moderate 296.31 MDD recurrent episode, mild 296.32 MDD recurrent episode, moderate
- The total score of HAMD-17 is ≥18 and ≤24 in both screening visit and baseline visit.
- The subject understands and consents to takes part in this clinical trials. The subjects should sign informed consent.
Key exclusion criteria (18 listed)
- The subject has a significant risk of suicide according to the investigator's opinion or has a score ≥3 on item 3(suicide assessment) of the HAMD or has made a suicide attempt.
- The subject has a current DSM-Ⅳ-TR axisⅠpsychiatric diagnosis other than depression.
- When the HAMD17 score of baseline visit compares with the screening visit, the decreasing rate is ≥25%.
- Any unstable cardiovascular, hepatic, renal, endocrine(thyroid gland dysfunction), blood,or other medical disease.
- Had a history of seizure disorder,except infantile febrile convulsion.
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 |
|---|---|---|
| Anyu PeiboAlso: PlaceboPlacebo | Drug | Anyu Peibo 0.4g per day, Anyu Peibo 0.8g per day, Anyu Peibo 1.2g per day, Anyu Peibo 1.6g per day, Placebo |
Primary outcome
The change of total score from baseline in MADRS scale
Time frame: 6 weeks
8 secondary outcomes
clinical response rate according to MADRS
Time frame: 6 weeks
clinical remission rate according to MADRS
Time frame: 6 weeks
CGI(CGI-S,CGI-I)
Time frame: 6 weeks
The change of total score from baseline in HAMD scale
Time frame: 6 weeks
decreasing rate from baseline in HAMD scale
Time frame: 6 weeks
clinical response rate according to HAMD
Time frame: 6 weeks
clinical remission rate according to HAMD
Time frame: 6 weeks
change from baseline in HAMA
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
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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.
Huafang LI, MD PhD principal investigator
Shanghai Mental Health Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anyu Peibo in people with Major Depressive Disorder (MDD), run by Shanghai Mental Health Center at 6 sites 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 3 inclusion and 18 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: finished, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of total score from baseline in MADRS scale (time frame: 6 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 2 Jan 2020.