Affective DisorderNCT03294525
Towards Neurobiology-based Diagnosis and Treatment of Affective Disorders
An observational study of Affective Disorder, run by Peking University at 1 site in China.
Trial summary
The project is a multi-center, prospective cohort study. The study's total targeted enrollment is 400 first-episode patients with major depressive disorder (MDD) and 400 healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Affective Disorder
- What is being tested?
- Escitalopram Pill, Duloxetine and Mirtazapine Pill
- Type of treatment
- Pill or oral medicine
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Jan 2016to Aug 2022
- Phase
- Observational
- 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
Study population: Patients with major depressive disorder
Who may be able to join
- 1. Patients with depression
- The inclusion criteria for depressed patients were: male or female outpatients aged between 18 and 55 years old
- Currently in acute depressive episode
- Total HAMD-17 score≥14 at baseline visit.
- The diagnosis of depression was confirmed by a trained psychiatrists using the Mini-International Neuropsychiatric Interview (MINI).
- The patients participating in imaging scans should additionally satisfy: not taking psychiatric drugs within last two weeks (except for benzodiazepine) or fluoxetine last one month
- Not receiving ECT within last 6 months.
Who cannot join
- Unable to complete the questionnaire and psychological assessment independently
- Significant cognitive impairments determined by system mental examination and inability to sign an informed consent form
- Past or presently suffering from other psychiatric disorders, alcohol and drug dependence
- Suffering from major physical diseases, such as cardiovascular and cerebrovascular diseases, respiratory diseases, kidney disease, cancer and so on; personality disorder
- Intellectual disabilities
- Suicidal behavior
- Being participating in other studies.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of mental health, Peking University
Beijing, Beijing Municipality, 100191
Tianmei Si, PhD., 8610-82801960, si.tian-mei@163.com
Tianmei Si, PhD.
About this study
Official title: Clinical Psychopharmacology Division
The project is a multi-center, prospective cohort study. The study's total targeted enrollment is 400 first-episode patients with major depressive disorder (MDD) and 400 healthy controls.
Read the detailed description
Four hundred patients with a primary diagnosis of depression and HAMD-17 scores ≥14 at baseline visit are to be assigned to one of the second-generation antidepressant drugs, including escitalopram, duloxetine, mirtazapine, paroxetine, sertraline, etc based on investigators' clinical practice. Initial treatment consists of a 8-week course with one of these monotherapies. Patients who meet criteria for full remission are followed for a 22-month follow-up phase to monitor for depression recurrence. Patients who do not remit are offered another 8 weeks of acute treatment, including combination therapy or switching to other antidepressant based on investigators' clinical practice. The clinical assessment (Hamilton Depression Rating Scale(HAMD)/ Clinical general impression (CGI) /the Positive and Negative Affect Schedule (PANAS) /subtypes of depression, Dimensional Anhedonia Rating Scale (DARS) , etc), early life stress, neuropsychological test, and biological examination (MRI, genetics, neurochemistry, and immunology) were conducted to identify the biomarkers associated with diagnosis, treatment efficacy prediction of depression. Among the 400 patients, about 100 patients receive MRI scans at baseline and after treatment.
- Conditions
- Affective Disorder
- Being tested
- Escitalopram Pill, Duloxetine, Mirtazapine Pill, Other Antidepressants
- Medical subject headings
- Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Escitalopram PillDrug
Also called Lexapro
escitalopram 10~20mg/day
DuloxetineDrug
Also called Cymbalta
duloxetine 30~120mg/day
Mirtazapine PillDrug
Also called Remeron
Mirtazapine 15~45mg/day
Other AntidepressantsDrug
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram-for MDD | Eligible patients were assigned to escitalopram treatment based on investigators' clinical practice. Receives: Drug: Escitalopram Pill | |
| Duloxetine-for MDD | Eligible patients were assigned to duloxetine treatment based on investigators' clinical practice. Receives: Drug: Duloxetine | |
| Mirtazepine-for MDD | Eligible patients were assigned to mirtazepine treatment based on investigators' clinical practice. Receives: Drug: Mirtazapine Pill | |
| other antidepressant-for MDD | Eligible patients were assigned to other antidepressant treatment (including sertraline, paroxetine, fluoxetine, venlafaxine, etc) based on investigators' clinical practice. Receives: Drug: Other Antidepressants |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in HAMD total scores
reduction more than 50% was regarded as response
Measured: 8 weeks
remision
HAMD total score less than 7
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study startJan 2016
- Primary completionDec 2021 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Affective DisorderStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Si Tianmei, Peking University
- Investigators
- Tianmei Si, PhD, Principal investigator, Sixth hospital of beijing university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294525
- Sponsor's protocol ID
- 001
- Status last verified
- Aug 2021
- First submitted
- 24 May 2016
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Dai YR, Wu YK, Chen X, Zeng YW, Li K, Li JT, Su YA, Zhu LL, Yan CG, Si TM. Eight-week antidepressant treatment changes intrinsic functional brain topology in first-episode drug-naive patients with major depressive disorder. J Affect Disord. 2023 May 15;329:225-234. doi: 10.1016/j.jad.2023.02.126. Epub 2023 Feb 28.
PubMed 36858265Lin J, Su Y, Rizvi SJ, Jagoda J, Li J, Wu Y, Dai Y, Zhang Y, Kennedy SH, Si T. Define and characterize the anhedonia in major depressive disorder: An explorative study. J Affect Disord. 2022 Sep 15;313:235-242. doi: 10.1016/j.jad.2022.06.082. Epub 2022 Jul 3.
PubMed 35788366Li L, Su YA, Wu YK, Castellanos FX, Li K, Li JT, Si TM, Yan CG. Eight-week antidepressant treatment reduces functional connectivity in first-episode drug-naive patients with major depressive disorder. Hum Brain Mapp. 2021 Jun 1;42(8):2593-2605. doi: 10.1002/hbm.25391. Epub 2021 Feb 27.
PubMed 33638263
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Psychopharmacology Division
- ClinicalTrials.gov ID
- NCT03294525
- Acronym / sponsor ID
- 001
- Conditions
- Affective Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 27 Sep 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.
The project is a multi-center, prospective cohort study. The study's total targeted enrollment is 400 first-episode patients with major depressive disorder (MDD) and 400 healthy controls.
Detailed description
Four hundred patients with a primary diagnosis of depression and HAMD-17 scores ≥14 at baseline visit are to be assigned to one of the second-generation antidepressant drugs, including escitalopram, duloxetine, mirtazapine, paroxetine, sertraline, etc based on investigators' clinical practice. Initial treatment consists of a 8-week course with one of these monotherapies. Patients who meet criteria for full remission are followed for a 22-month follow-up phase to monitor for depression recurrence. Patients who do not remit are offered another 8 weeks of acute treatment, including combination therapy or switching to other antidepressant based on investigators' clinical practice. The clinical assessment (Hamilton Depression Rating Scale(HAMD)/ Clinical general impression (CGI) /the Positive and Negative Affect Schedule (PANAS) /subtypes of depression, Dimensional Anhedonia Rating Scale (DARS) , etc), early life stress, neuropsychological test, and biological examination (MRI, genetics, neurochemistry, and immunology) were conducted to identify the biomarkers associated with diagnosis, treatment efficacy prediction of depression. Among the 400 patients, about 100 patients receive MRI scans at baseline and after treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Escitalopram-for MDD | – | Drug: Escitalopram PillEligible patients were assigned to escitalopram treatment based on investigators' clinical practice. |
| Duloxetine-for MDD | – | Drug: DuloxetineEligible patients were assigned to duloxetine treatment based on investigators' clinical practice. |
| Mirtazepine-for MDD | – | Drug: Mirtazapine PillEligible patients were assigned to mirtazepine treatment based on investigators' clinical practice. |
| other antidepressant-for MDD | – | Drug: Other AntidepressantsEligible patients were assigned to other antidepressant treatment (including sertraline, paroxetine, fluoxetine, venlafaxine, etc) based on investigators' clinical practice. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with major depressive disorder
Key inclusion criteria (7 listed)
- 1. Patients with depression
- The inclusion criteria for depressed patients were: male or female outpatients aged between 18 and 55 years old
- Currently in acute depressive episode
- Total HAMD-17 score≥14 at baseline visit.
- The diagnosis of depression was confirmed by a trained psychiatrists using the Mini-International Neuropsychiatric Interview (MINI).
Key exclusion criteria (7 listed)
- Unable to complete the questionnaire and psychological assessment independently
- Significant cognitive impairments determined by system mental examination and inability to sign an informed consent form
- Past or presently suffering from other psychiatric disorders, alcohol and drug dependence
- Suffering from major physical diseases, such as cardiovascular and cerebrovascular diseases, respiratory diseases, kidney disease, cancer and so on; personality disorder
- Intellectual disabilities
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 |
|---|---|---|
| Escitalopram PillAlso: Lexaproescitalopram 10~20mg/day | Drug | Escitalopram-for MDD |
| DuloxetineAlso: Cymbaltaduloxetine 30~120mg/day | Drug | Duloxetine-for MDD |
| Mirtazapine PillAlso: RemeronMirtazapine 15~45mg/day | Drug | Mirtazepine-for MDD |
| Other Antidepressants | Drug | other antidepressant-for MDD |
Primary outcome
reduction in HAMD total scores
Time frame: 8 weeks
reduction more than 50% was regarded as response
remision
Time frame: 8 weeks
HAMD total score less than 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Derived from this study: PubMed 36858265Dai YR, Wu YK, Chen X, Zeng YW, Li K, Li JT, Su YA, Zhu LL, Yan CG, Si TM. Eight-week antidepressant treatment changes intrinsic functional brain topology in first-episode drug-naive patients with major depressive disorder. J Affect Disord. 2023 May 15;329:225-234. doi: 10.1016/j.jad.2023.02.126. Epub 2023 Feb 28.
- Derived from this study: PubMed 35788366Lin J, Su Y, Rizvi SJ, Jagoda J, Li J, Wu Y, Dai Y, Zhang Y, Kennedy SH, Si T. Define and characterize the anhedonia in major depressive disorder: An explorative study. J Affect Disord. 2022 Sep 15;313:235-242. doi: 10.1016/j.jad.2022.06.082. Epub 2022 Jul 3.
- Derived from this study: PubMed 33638263Li L, Su YA, Wu YK, Castellanos FX, Li K, Li JT, Si TM, Yan CG. Eight-week antidepressant treatment reduces functional connectivity in first-episode drug-naive patients with major depressive disorder. Hum Brain Mapp. 2021 Jun 1;42(8):2593-2605. doi: 10.1002/hbm.25391. Epub 2021 Feb 27.
- Individual participant dataSharing planned: No
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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.
Tianmei Si, PhD principal investigator
Sixth hospital of beijing university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Affective Disorder, run by Peking University 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 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 30 Aug 2021. 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. 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 Yunai Su, PhD (010-62723761, suyunai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in HAMD total scores (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 NCT03294525, which also lists 3 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 30 Aug 2021; AzTrials last refreshed its copy on 8 Nov 2026.