Depressive Disorder, MajorNCT02023567
Objective Diagnostic Markers and Personalized Intervention in MDD Patients
A study testing SSRIs in people with Depressive Disorder, Major, run by Peking University at 9 sites in China.
Trial summary
Major depressive disorder (MDD) is one of the most common psychiatric disorders, with high recurrence rate, suicide rate and disability rate. It's reported that the global burden caused by MDD will be up to the second rank among all the disease burdens by 2020. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- SSRIs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 9 sitesChina
- Study dates
- Nov 2013to Dec 2016
- Phase
- Interventional
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-55, male or female;
- The diagnosis of MDD consistent with DSM-IV (M.I.N.I)
- First-episode or relapsed;
- Certain ability of reading and writing to complete the questionnaire survey and psychological assessment.
- All participants provide written confirmation of informed consent prior to engaging the study protocol.
- age between 18 and 55 years at the time of enrollment;
- providing written confirmation of informed consent prior to engaging the study.
Who cannot join
- Current psychopathology or a history of neurologic conditions, including alcohol/substances dependence, the diagnosis of cognition impairment;
- Severe somatic diseases, such as severe cardio-cerebral vascular diseases, respiratory diseases, liver diseases, kidney diseases, or malignant tumors;
- Not signed the informed consent;
- Been engaging other studies.
- For Healthy control group
- lifetime or current diagnosis of any mental diseases;
Show all 9Show fewer
- severe somatic diseases, such as severe cardio-cerebral vascular diseases, respiratory diseases, liver diseases, kidney diseases, or malignant tumors;
- not signed the informed consent;
- been engaging other studies.
Trial locations and contacts
9 sites in 1 country.
Gang Wang, MD contact
9 sites in 1 country
China9 sites, 2 recruiting
- Recruiting
Beijing Anding Hospital
Beijing, Beijing Municipality
Gang Wang, 86-13911695727, gangwangdoc@gmail.com
Changqing Hu, 86-13661106500, coannhu@126.com
- Active, not recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
- Recruiting
Peking University Sixth Hospital
Beijing, Beijing Municipality
Qi Liu, 86-10-82801955 ext. 86-13671013073, liu_qee@sina.com
- Active, not recruiting
Dalian Seventh People's Hospital
Dalian, Liaoning
- Active, not recruiting
First Hospital of China Medical University
Shenyang, Liaoning
- Active, not recruiting
Hebei Medical University First Hospital
Shijiazhuang, Hebei
- Active, not recruiting
First Hospital of Shanxi Medical University
Taiyuan, Shanxi
- Active, not recruiting
Tianjin Anding Hospital
Tianjin, Tianjin Municipality
- Active, not recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
About this study
Official title: The Establishment of the Objective Diagnostic Markers and Personalized Medical Intervention in Patients With Major Depressive Disorders (MDD)
Major depressive disorder (MDD) is one of the most common psychiatric disorders, with high recurrence rate, suicide rate and disability rate. It's reported that the global burden caused by MDD will be up to the second rank among all the disease burdens by 2020. China is also confronted with the daunting challenges against MDD. It's assessed that the monthly incidence of MDD is 6.1%, non-hospitalizing rate reaches up to 92% and the non-treatment rate is approximate 95%. However, to date, the pathogenesis of MDD is obscure and the current therapies don't work well. Therefore, it's urgent and critical to elucidate the pathogenesis of MDD, to develop early diagnostic criteria and effective intervention in MDD. Considering the diversity of weights on genetic factor and environmental factor in MDD, in this project, the investigators aim firstly to explore the effect of "genetic-environmental interaction"on the pathogeny of MDD for classifying MDD into "genetic type", "environmental type" and "others" based on a case-control study. We next conduct the neurobiological, neurocognitive and psycho-behavioral assessments among MDD, schizophrenia and healthy groups to screen the salient endophenotypes for establishing the diagnostic models of MDD . The investigators further analyse the changes of these indicators after 8 weeks'medication to select the potential predictors for therapeutic evaluations and interventional options in MDD patients. Finally, the investigators continue a 2-year follow-up study to test and verify the predictors of prognosis in MDD patients.
- Conditions
- Depressive Disorder, Major
- Being tested
- SSRIs
- 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.
SSRIsDrug
Also called selective serotonin reuptake inhibitors
fluoxertine hydrochloride 20-60mg/day, paroxetine hydrochloride 20-60mg/day, sertraline hydrochloride 50-200mg/day, citalopram 20-60mg/day, escitalopram 10-20mg/day, fluvoxamine 50-300mg/day
| Study group | Role | What they receive |
|---|---|---|
| MDD group | Experimental | Drugs: SSRIs fluoxertine hydrochloride (20- 60m/day),paroxetine hydrochloride (20- 60m/day),sertraline hydrochloride (50- 200m/day),citalopram (20-60m/day), escitalopram (10-20mg/day),fluvoxamine (50-300mg/day) Receives: Drug: SSRIs |
| Healthy controls | No intervention | This group just receive baseline evaluation and did not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of HAMD total score at 8 weeks from baseline
The scores are assessed at 0,2,4,8 weeks since the medication begins for MDD group
Measured: week 0,2,4,8
Secondary outcomes (4)
The changes of HAMA total score at 8 weeks from baseline
The scores are assessment at 0,2,4,8 weeks since the medication begins for MDD group
Measured: week 0,2,4,8
The change of CGI score at 8 weeks from baseline
The scores are assessment at 0,2,4,8 weeks since the medication begins for MDD group
Measured: week 0,2,4,8
The prognosis after the intervention
Measured: Up to 2 years
Number of participants with serious and non-serious adverse events
Measured: Up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Capital Medical University, Peking Union Medical College Hospital, Tianjin Medical University General Hospital, Tianjin Anding Hospital, The First Hospital of Hebei Medical University, First Hospital of China Medical University, Dalian Seventh People's Hospital, The First Affiliated Hospital of Shanxi Medical University
- Responsible party
- Principal investigator, Xin Yu, Peking University
- Investigators
- Xin Yu, MD, Principal investigator, Peking University Sixth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023567
- Sponsor's protocol ID
- 2013CB531305
- Status last verified
- May 2016
- First submitted
- 15 Dec 2013
- Last updated
- 20 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: After enrollment completion,we will decided whether share data or not.
Publications
Xin LM, Lin JY, Fan HZ, FengYan, Yu X, Su YA, Si TM. Neurocognitive function profiles in Chinese patients with melancholic vs. non-melancholic major depressive disorder. BMC Psychiatry. 2026 Apr 11;26(1):402. doi: 10.1186/s12888-026-08043-8.
PubMed 41965575Cui F, Liu Q, Lv X, Tian H, Wei J, Zhang K, Zhu G, Chen Q, Wang G, Wang X, Zhang N, Huang Y, Si T, Yu X. Effect of childhood trauma on cognitive function in individuals with major depressive disorder and healthy controls. J Affect Disord. 2025 Feb 15;371:196-204. doi: 10.1016/j.jad.2024.10.059. Epub 2024 Oct 19.
PubMed 39433132Lin J, Li JT, Kong L, Liu Q, Lv X, Wang G, Wei J, Zhu G, Chen Q, Tian H, Zhang K, Wang X, Zhang N, Yu X, Si T, Su YA. Proinflammatory phenotype in major depressive disorder with adulthood adversity: In line with social signal transduction theory of depression. J Affect Disord. 2023 Nov 15;341:275-282. doi: 10.1016/j.jad.2023.08.104. Epub 2023 Aug 30.
PubMed 37657624Lin J, Su Y, Lv X, Liu Q, Wang G, Wei J, Zhu G, Chen Q, Tian H, Zhang K, Wang X, Zhang N, Yan H, Wang Y, Yu X, Si T. Childhood adversity, adulthood adversity and suicidal ideation in Chinese patients with major depressive disorder: in line with stress sensitization. Eur Arch Psychiatry Clin Neurosci. 2022 Aug;272(5):887-896. doi: 10.1007/s00406-021-01375-4. Epub 2022 Jan 5.
PubMed 34985583Cui F, Liu Q, Lv X, Leonhart R, Tian H, Wei J, Zhang K, Zhu G, Chen Q, Wang G, Wang X, Zhang N, Huang Y, Si T, Yu X. Severe sleep disturbance is associated with executive function impairment in patients with first-episode, treatment-naive major depressive disorders. BMC Psychiatry. 2021 Apr 19;21(1):198. doi: 10.1186/s12888-021-03194-2.
PubMed 33874911Lin J, Su Y, Lv X, Liu Q, Wang G, Wei J, Zhu G, Chen Q, Tian H, Zhang K, Wang X, Zhang N, Wang Y, Yu X, Si T. Perceived stressfulness mediates the effects of subjective social support and negative coping style on suicide risk in Chinese patients with major depressive disorder. J Affect Disord. 2020 Mar 15;265:32-38. doi: 10.1016/j.jad.2020.01.026. Epub 2020 Jan 10.
PubMed 31959583Lin JY, Huang Y, Su YA, Yu X, Lyu XZ, Liu Q, Si TM. Association between Perceived Stressfulness of Stressful Life Events and the Suicidal Risk in Chinese Patients with Major Depressive Disorder. Chin Med J (Engl). 2018 Apr 20;131(8):912-919. doi: 10.4103/0366-6999.229898.
PubMed 29664050Lv X, Si T, Wang G, Wang H, Liu Q, Hu C, Wang J, Su Y, Huang Y, Jiang H, Yu X. The establishment of the objective diagnostic markers and personalized medical intervention in patients with major depressive disorder: rationale and protocol. BMC Psychiatry. 2016 Jul 15;16:240. doi: 10.1186/s12888-016-0953-z.
PubMed 27422150
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Establishment of the Objective Diagnostic Markers and Personalized Medical Intervention in Patients With Major Depressive Disorders (MDD)
- ClinicalTrials.gov ID
- NCT02023567
- Acronym / sponsor ID
- 2013CB531305
- Conditions
- Depressive Disorder, Major
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Capital Medical University, Peking Union Medical College Hospital, Tianjin Medical University General Hospital, Tianjin Anding Hospital, The First Hospital of Hebei Medical University, First Hospital of China Medical University, Dalian Seventh People's Hospital, The First Affiliated Hospital of Shanxi Medical University
- Study start
- Nov 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 30 Dec 2013 (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.
Major depressive disorder (MDD) is one of the most common psychiatric disorders, with high recurrence rate, suicide rate and disability rate. It's reported that the global burden caused by MDD will be up to the second rank among all the disease burdens by 2020. China is also confronted with the daunting challenges against MDD. It's assessed that the monthly incidence of MDD is 6.1%, non-hospitalizing rate reaches up to 92% and the non-treatment rate is approximate 95%. However, to date, the pathogenesis of MDD is obscure and the current therapies don't work well. Therefore, it's urgent and critical to elucidate the pathogenesis of MDD, to develop early diagnostic criteria and effective intervention in MDD. Considering the diversity of weights on genetic factor and environmental factor in MDD, in this project, the investigators aim firstly to explore the effect of "genetic-environmental interaction"on the pathogeny of MDD for classifying MDD into "genetic type", "environmental type" and "others" based on a case-control study. We next conduct the neurobiological, neurocognitive and psycho-behavioral assessments among MDD, schizophrenia and healthy groups to screen the salient endophenotypes for establishing the diagnostic models of MDD . The investigators further analyse the changes of these indicators after 8 weeks'medication to select the potential predictors for therapeutic evaluations and interventional options in MDD patients. Finally, the investigators continue a 2-year follow-up study to test and verify the predictors of prognosis in MDD patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MDD group | Experimental | Drug: SSRIsDrugs: SSRIs fluoxertine hydrochloride (20- 60m/day),paroxetine hydrochloride (20- 60m/day),sertraline hydrochloride (50- 200m/day),citalopram (20-60m/day), escitalopram (10-20mg/day),fluvoxamine (50-300mg/day) |
| Healthy controls | No intervention | –This group just receive baseline evaluation and did not receive any intervention. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- age between 18 and 55 years at the time of enrollment;
- providing written confirmation of informed consent prior to engaging the study.
Key exclusion criteria (9 listed)
- For Healthy control group
- lifetime or current diagnosis of any mental diseases;
- severe somatic diseases, such as severe cardio-cerebral vascular diseases, respiratory diseases, liver diseases, kidney diseases, or malignant tumors;
- not signed the informed consent;
- been engaging other studies.
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 |
|---|---|---|
| SSRIsAlso: selective serotonin reuptake inhibitorsfluoxertine hydrochloride 20-60mg/day, paroxetine hydrochloride 20-60mg/day, sertraline hydrochloride 50-200mg/day, citalopram 20-60mg/day, escitalopram 10-20mg/day, fluvoxamine 50-300mg/day | Drug | MDD group |
Primary outcome
The changes of HAMD total score at 8 weeks from baseline
Time frame: week 0,2,4,8
The scores are assessed at 0,2,4,8 weeks since the medication begins for MDD group
4 secondary outcomes
The changes of HAMA total score at 8 weeks from baseline
Time frame: week 0,2,4,8
The change of CGI score at 8 weeks from baseline
Time frame: week 0,2,4,8
The prognosis after the intervention
Time frame: Up to 2 years
Number of participants with serious and non-serious adverse events
Time frame: Up to two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
- Derived from this study: PubMed 41965575Xin LM, Lin JY, Fan HZ, FengYan, Yu X, Su YA, Si TM. Neurocognitive function profiles in Chinese patients with melancholic vs. non-melancholic major depressive disorder. BMC Psychiatry. 2026 Apr 11;26(1):402. doi: 10.1186/s12888-026-08043-8.
- Derived from this study: PubMed 39433132Cui F, Liu Q, Lv X, Tian H, Wei J, Zhang K, Zhu G, Chen Q, Wang G, Wang X, Zhang N, Huang Y, Si T, Yu X. Effect of childhood trauma on cognitive function in individuals with major depressive disorder and healthy controls. J Affect Disord. 2025 Feb 15;371:196-204. doi: 10.1016/j.jad.2024.10.059. Epub 2024 Oct 19.
- Derived from this study: PubMed 37657624Lin J, Li JT, Kong L, Liu Q, Lv X, Wang G, Wei J, Zhu G, Chen Q, Tian H, Zhang K, Wang X, Zhang N, Yu X, Si T, Su YA. Proinflammatory phenotype in major depressive disorder with adulthood adversity: In line with social signal transduction theory of depression. J Affect Disord. 2023 Nov 15;341:275-282. doi: 10.1016/j.jad.2023.08.104. Epub 2023 Aug 30.
- Derived from this study: PubMed 34985583Lin J, Su Y, Lv X, Liu Q, Wang G, Wei J, Zhu G, Chen Q, Tian H, Zhang K, Wang X, Zhang N, Yan H, Wang Y, Yu X, Si T. Childhood adversity, adulthood adversity and suicidal ideation in Chinese patients with major depressive disorder: in line with stress sensitization. Eur Arch Psychiatry Clin Neurosci. 2022 Aug;272(5):887-896. doi: 10.1007/s00406-021-01375-4. Epub 2022 Jan 5.
- Derived from this study: PubMed 33874911Cui F, Liu Q, Lv X, Leonhart R, Tian H, Wei J, Zhang K, Zhu G, Chen Q, Wang G, Wang X, Zhang N, Huang Y, Si T, Yu X. Severe sleep disturbance is associated with executive function impairment in patients with first-episode, treatment-naive major depressive disorders. BMC Psychiatry. 2021 Apr 19;21(1):198. doi: 10.1186/s12888-021-03194-2.
- Derived from this study: PubMed 31959583Lin J, Su Y, Lv X, Liu Q, Wang G, Wei J, Zhu G, Chen Q, Tian H, Zhang K, Wang X, Zhang N, Wang Y, Yu X, Si T. Perceived stressfulness mediates the effects of subjective social support and negative coping style on suicide risk in Chinese patients with major depressive disorder. J Affect Disord. 2020 Mar 15;265:32-38. doi: 10.1016/j.jad.2020.01.026. Epub 2020 Jan 10.
- Derived from this study: PubMed 29664050Lin JY, Huang Y, Su YA, Yu X, Lyu XZ, Liu Q, Si TM. Association between Perceived Stressfulness of Stressful Life Events and the Suicidal Risk in Chinese Patients with Major Depressive Disorder. Chin Med J (Engl). 2018 Apr 20;131(8):912-919. doi: 10.4103/0366-6999.229898.
- Derived from this study: PubMed 27422150Lv X, Si T, Wang G, Wang H, Liu Q, Hu C, Wang J, Su Y, Huang Y, Jiang H, Yu X. The establishment of the objective diagnostic markers and personalized medical intervention in patients with major depressive disorder: rationale and protocol. BMC Psychiatry. 2016 Jul 15;16:240. doi: 10.1186/s12888-016-0953-z.
- Individual participant dataSharing planned: Undecided. After enrollment completion,we will decided whether share data or not.
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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.
Gang Wang, MD contact
Xin Yu, MD principal investigator
Peking University Sixth Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SSRIs in people with Depressive Disorder, Major, run by Peking University at 9 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 7 inclusion and 9 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 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Tianmei Si, MD (86-10-62723748 ext. 86-139109877, si.tian-mei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of HAMD total score at 8 weeks from baseline (time frame: week 0,2,4,8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02023567, which also lists 8 linked publications.
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 20 May 2016.