Major Depressive Disorder (MDD)Phase 2NCT02395263
Comparison of Yuxintine With Placebo in Treatment of MDD
A Phase 2 study testing Yuxintine in people with Major Depressive Disorder (MDD), run by Shanghai Mental Health Center at 10 sites in China.
Trial summary
The purpose of this study is to determine whether Yuxintine Capsule in different doses are effective in the treatment of Depression. And to explore the preliminary information of safety and efficacy of Yuxintine 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?
- Yuxintine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 10 sitesChina
- Study dates
- Mar 2015to Apr 2016
- 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: 296.2 and 296.3.
- The Subject with Heart-Spleen Deficiency based on the CTM.
- The total score of MADRS is ≥22 in both screening visit and baseline visit.
- The total score of HAMD-17 is ≥18 and ≤30, AND item 1 ≥2 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 made a suicide attempt in recent 6 months or has a score ≥3 on item 3(suicide assessment) of the HAMD.
- The subject has a current DSM-Ⅳ-TR axisⅠpsychiatric diagnosis other than depression.
- When the MADRS score of baseline visit compares with the screening visit, the decreasing rate is ≥25%.
- Any unstable cardiovascular, hepatic, renal, endocrine(thyroid gland dysfunction), blood(e.g. bleeding tendency),or other medical disease.
- Had a history of seizure disorder,except infantile febrile convulsion.
- The subject has accepted psychosurgery or electroconvulsive therapy within 3 months.
Show all 18Show fewer
- 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 index above toplimit, abnormal coagulation function and clinical significance of abnormality, i.e. Prothrombin time shorten or extend more than 3 seconds or a dynamic variation or APTT prolonged more than 10 seconds,AND fibrinogen L or been progressive decline, or > 4.0 g/L).
- 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 Ginseng, 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.
- 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).
- The subject has participated in a drug clinical trial within 3 months before screening.
- The investigator think the subject is unsuitable to enrol in this clinical trial.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Peking University Sixth Hospital
Beijing, Beijing Municipality, 100083
Hongyan ZHANG, MD, 13601237138, sally_zhy@sina.com
Beijing HuiLongGuan Hospital
Beijing, Beijing Municipality, 100096
Shaoxiao YAN, MD, 18513880816, 13811217058@163.com
Hunan Brain Hospital
Changsha, Hunan, 410007
Tiansheng GUO, MD, 13808431145, 1945461929@qq.com
the First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 404000
Huaqing MENG, MD, 13320248988, mhq99666@sina.com
Affiliated Hospital of Guiyang Medical College
Guiyang, Guizhou, 550004
Yiming WANG, MD, 13511967666, 754603457@qq.com
the People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021
Jianqing TAO, MD, 18607713688, tjq3238@163.com
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Shenzhen Mental Health Center
Shenzhen, Guangdong, 518020
Tiebang LIU, MD, 13823501800, Liutbsz@126.com
Hebei Mental Health Center
Shijiazhuang, Hebei, 071000
Yuxin LI, MD, 13931292966, liuyuanliyuxin@126.com
Tianjin Anding Hospital
Tianjin, Tianjin Municipality, 300074
Yi WANG, MD, 13820826767, adyy003@163.com
About this study
Official title: Proof Of Concept Study of Yuxintine 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 Yuxintine Capsule in different doses are effective in the treatment of Depression.
And to explore the preliminary information of safety and efficacy of Yuxintine Capsule in the Chinese Patients with Depression.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- Yuxintine
- 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.
YuxintineDrug
| Study group | Role | What they receive |
|---|---|---|
| Yuxintine 200mg per day | Experimental | Yuxintine 200mg oral, once a day, 6 weeks Receives: Drug: Yuxintine |
| Yuxintine 300mg per day | Experimental | Yuxintine 300mg oral, once a day, 6 weeks Receives: Drug: Yuxintine |
| Yuxintine 400mg per day | Experimental | Yuxintine 400mg oral, once a day, 6 weeks Receives: Drug: Yuxintine |
| Placebo | Placebo comparator | Placebo oral, once a day, 6 weeks Receives: Drug: Yuxintine |
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 remission rate according to HAMD
Measured: 6 weeks
change from baseline in HAMA
Measured: 6 weeks
Traditional Chinese Medicine Syndrome Scale
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 posted23 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2016 (estimated)
- Study completionApr 2016 (estimated)
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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Innovative Research Center of Traditional Chinese Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395263
- Sponsor's protocol ID
- Yuxintine Capsule-MDD-Ⅱb
- Other IDs
- 2012ZX09303-003
- Status last verified
- Mar 2015
- First submitted
- 17 Mar 2015
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof Of Concept Study of Yuxintine in the Treatment of Major Depressive Disorder(MDD): a Randomized, Double-Blind, Placebo-Paralleled,Dose-Finding, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT02395263
- Acronym / sponsor ID
- Yuxintine Capsule-MDD-Ⅱb
- Conditions
- Major Depressive Disorder (MDD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- Shanghai Innovative Research Center of Traditional Chinese Medicine
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 23 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 Yuxintine Capsule in different doses are effective in the treatment of Depression.
And to explore the preliminary information of safety and efficacy of Yuxintine 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
- 4
| Arm | Type | Receives |
|---|---|---|
| Yuxintine 200mg per day | Experimental | Drug: YuxintineYuxintine 200mg oral, once a day, 6 weeks |
| Yuxintine 300mg per day | Experimental | Drug: YuxintineYuxintine 300mg oral, once a day, 6 weeks |
| Yuxintine 400mg per day | Experimental | Drug: YuxintineYuxintine 400mg oral, once a day, 6 weeks |
| Placebo | Placebo comparator | Drug: YuxintinePlacebo oral, once a day, 6 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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: 296.2 and 296.3.
- The Subject with Heart-Spleen Deficiency based on the CTM.
- The total score of MADRS is ≥22 in both screening visit and baseline visit.
- The total score of HAMD-17 is ≥18 and ≤30, AND item 1 ≥2 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 made a suicide attempt in recent 6 months or has a score ≥3 on item 3(suicide assessment) of the HAMD.
- The subject has a current DSM-Ⅳ-TR axisⅠpsychiatric diagnosis other than depression.
- When the MADRS score of baseline visit compares with the screening visit, the decreasing rate is ≥25%.
- Any unstable cardiovascular, hepatic, renal, endocrine(thyroid gland dysfunction), blood(e.g. bleeding tendency),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 |
|---|---|---|
| Yuxintine | Drug | Placebo, Yuxintine 200mg per day, Yuxintine 300mg per day, Yuxintine 400mg per day |
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 remission rate according to HAMD
Time frame: 6 weeks
change from baseline in HAMA
Time frame: 6 weeks
Traditional Chinese Medicine Syndrome Scale
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
Related trials for Major Depressive Disorder (MDD)
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
RecruitingPhase 2
Psilocybin With Pimavanserin Compared to Psilocybin Alone for the Treatment of Major Depressive Disorder
Major Depressive Disorder
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.
10 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 Yuxintine in people with Major Depressive Disorder (MDD), run by Shanghai Mental Health Center at 10 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 5 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: status not confirmed, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huafang LI, MD PhD (86-21-34773128, lhlh_5@163.com), or a site near the patient. 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 24 Mar 2015.