Major Depressive DisorderNCT03230682
Eealy Improvement Predicts Antidepressants Response in Adults With Major Depression Disorder
An observational study of Major Depressive Disorder, run by Huashan Hospital at 1 site in China.
Trial summary
Early improvemrnt, decreased 20% in the 17 items of Hamilton Depression Rating Scale (HAMD-17) at the second week of the treatment of major depression disorder (MDD), can arguably predict the remission at the 12th week. Read more about this study
- Who is it for?
- Ages 16 to 55 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- antidepressant
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 25 Jul 2017to 11 Jul 2018
- How long will I take part?
- 3 Months
- 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 16 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The han nationality who living in Shanghai, Zhejiang Province and Jiangsu Province
Who may be able to join
- right-handed; HAMD-17 more than 17; diagnosed with MDD by the Structured Clinical Interview for DSM-IV
Who cannot join
- patients diagnosed with other condition in DSM-IV Axis I; pregnency; Thyroid disease; Heart Disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dept. of Neurology, Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Jie Tang, +8618818210880, tan11711@hotmail.com
About this study
Early improvemrnt, decreased 20% in the 17 items of Hamilton Depression Rating Scale (HAMD-17) at the second week of the treatment of major depression disorder (MDD), can arguably predict the remission at the 12th week. Our observation study including 80 MDD patients will access resting-state function MRI to finding factors which infuencing early improvemrnt, respone and remission of antidepressants.
- Conditions
- Major Depressive Disorder
- Being tested
- antidepressant
- Keywords
- early improvement, antidepressants, major depression diorder, resting-state fMRI
- 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.
antidepressantDrug
regular one-drups treatment of selective serotonin reuptake inhibitor(SSRIs)
| Study group | Role | What they receive |
|---|---|---|
| major depressive disorder | Not described Receives: Drug: antidepressant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early improvement
obtain 20% decrease of HAMD-17
Measured: the second week of treatment
Secondary outcomes (1)
Response
obtain 50% decrease of HAMD-17
Measured: the 12th week of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start25 Jul 2017 (estimated)
- Primary completion11 Jun 2018 (estimated)
- Study completion11 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe 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
- 80 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianhui Fu, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230682
- Sponsor's protocol ID
- KY2017-01
- Status last verified
- Jul 2017
- First submitted
- 24 Jul 2017
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wagner S, Engel A, Engelmann J, Herzog D, Dreimuller N, Muller MB, Tadic A, Lieb K. Early improvement as a resilience signal predicting later remission to antidepressant treatment in patients with Major Depressive Disorder: Systematic review and meta-analysis. J Psychiatr Res. 2017 Nov;94:96-106. doi: 10.1016/j.jpsychires.2017.07.003. Epub 2017 Jul 4.
PubMed 28697423Szegedi A, Jansen WT, van Willigenburg AP, van der Meulen E, Stassen HH, Thase ME. Early improvement in the first 2 weeks as a predictor of treatment outcome in patients with major depressive disorder: a meta-analysis including 6562 patients. J Clin Psychiatry. 2009 Mar;70(3):344-53. doi: 10.4088/jcp.07m03780. Epub 2009 Feb 24.
PubMed 19254516
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eealy Improvement Predicts Antidepressants Response in Adults With Major Depression Disorder
- ClinicalTrials.gov ID
- NCT03230682
- Acronym / sponsor ID
- KY2017-01
- Conditions
- Major Depressive Disorder
- Keywords
- early improvement, antidepressants, major depression diorder, resting-state fMRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 25 Jul 2017 (estimated)
- Primary completion
- 11 Jun 2018 (estimated)
- Study completion
- 11 Jul 2018 (estimated)
- First posted
- 26 Jul 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.
Early improvemrnt, decreased 20% in the 17 items of Hamilton Depression Rating Scale (HAMD-17) at the second week of the treatment of major depression disorder (MDD), can arguably predict the remission at the 12th week. Our observation study including 80 MDD patients will access resting-state function MRI to finding factors which infuencing early improvemrnt, respone and remission of antidepressants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| major depressive disorder | – | Drug: antidepressant |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The han nationality who living in Shanghai, Zhejiang Province and Jiangsu Province
Key inclusion criteria (1 listed)
- right-handed; HAMD-17 more than 17; diagnosed with MDD by the Structured Clinical Interview for DSM-IV
Key exclusion criteria (1 listed)
- patients diagnosed with other condition in DSM-IV Axis I; pregnency; Thyroid disease; Heart Disease
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 |
|---|---|---|
| antidepressantregular one-drups treatment of selective serotonin reuptake inhibitor(SSRIs) | Drug | major depressive disorder |
Primary outcome
Early improvement
Time frame: the second week of treatment
obtain 20% decrease of HAMD-17
1 secondary outcome
Response
Time frame: the 12th week of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
- Background: PubMed 28697423Wagner S, Engel A, Engelmann J, Herzog D, Dreimuller N, Muller MB, Tadic A, Lieb K. Early improvement as a resilience signal predicting later remission to antidepressant treatment in patients with Major Depressive Disorder: Systematic review and meta-analysis. J Psychiatr Res. 2017 Nov;94:96-106. doi: 10.1016/j.jpsychires.2017.07.003. Epub 2017 Jul 4.
- Results publication: PubMed 19254516Szegedi A, Jansen WT, van Willigenburg AP, van der Meulen E, Stassen HH, Thase ME. Early improvement in the first 2 weeks as a predictor of treatment outcome in patients with major depressive disorder: a meta-analysis including 6562 patients. J Clin Psychiatry. 2009 Mar;70(3):344-53. doi: 10.4088/jcp.07m03780. Epub 2009 Feb 24.
- Individual participant dataSharing planned: Undecided
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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.
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 Major Depressive Disorder, run by Huashan Hospital 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 1 inclusion and 1 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 26 Jul 2017. 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 Shi Shenxun, PhD (13816203171, shishenxun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early improvement (time frame: the second week of treatment). 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 NCT03230682, which also lists 2 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 26 Jul 2017.