DepressionNCT00703742
A Neuroimaging and Epigenetic Investigation of Antidepressants in Depression
A study testing Escitalopram in people with Depression and Depression Secondary to Other Disease, run by Kunming Medical University at 1 site in China.
Trial summary
The purpose of this study is: 1. to find out the structural or functional effects of selective serotonin reuptake inhibitors (SSRI) in major depressive disorder (MDD); 2. find special abnormalities in depression secondary to other disease, e.g., autoimmune disease like systemic lupus erythematosus (SLE). 3. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Depression Secondary to Other Disease
- What is being tested?
- Escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jun 2008to Jun 2011
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- DSM-IV Major Depression or Dysthymia
- Age 18-65
- Physically healthy
- Drug-free
Who cannot join
- Body metal (e.g., wire stitches, screws in bones, stainless steel hips)
- History of Psychosis or Epilepsy
- Current (past six months) Substance Use Disorder (illicit drugs and/or alcohol)
- Bipolar I
- Need for wash-out from effective treatment in order to participate
- Pregnant
- High suicide risk
- Currently taking (within 2 weeks; 4 weeks for Fluoxetine) antidepressants
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Kunming Medical College
Kunming, Yunnan, 650031
About this study
The purpose of this study is:
- to find out the structural or functional effects of selective serotonin reuptake inhibitors (SSRI) in major depressive disorder (MDD);
- find special abnormalities in depression secondary to other disease, e.g., autoimmune disease like systemic lupus erythematosus (SLE).
- find the relationship between the efficacy of antidepressant and the change of neuroimaging in MDD
- to find possible predispose to MDD
- to explore the DNA methylation status in depression;
Read the detailed description
- to explore the pathology of depression
- to identify the difference between MDD and depression secondary to other disease ,especially autoimmune disease
- to explore the effect of gene-environment interaction on the epigenetic regulation of the depression
- Conditions
- Depression, Depression Secondary to Other Disease
- Being tested
- Escitalopram
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
A,1: Escitalopram, oral, 20 mg/day, 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| A,1 | Experimental | A: Escitalopram, 20 mg/day,8weeks Receives: Drug: Escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of fMRI after medication
Measured: baseline, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kunming Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Academy of Sciences
- Responsible party
- Principal investigator, Yuqi Cheng, Kunming Medical University
- Investigators
- Xu Xiufeng, Study director, Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00703742
- Sponsor's protocol ID
- Kunming MC
- Status last verified
- Sep 2019
- First submitted
- 20 Jun 2008
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yang Y, Tao L, Zhao R, Bai R, Liu S, Zhang G, Li S, Xu X, Cheng Y, Xu J. Influence of sex and systemic lupus erythematosus disease status on cerebral cortex structure. Lupus Sci Med. 2026 Jun 25;13(1):e002032. doi: 10.1136/lupus-2026-002032.
PubMed 42349919Chu Z, Yuan L, He M, Cheng Y, Lu Y, Xu X, Shen Z. Atrophy of bilateral nucleus accumbens in melancholic depression. Neuroreport. 2023 Jun 7;34(10):493-500. doi: 10.1097/WNR.0000000000001915. Epub 2023 May 31.
PubMed 37270840Cheng Y, Xu J, Yu H, Nie B, Li N, Luo C, Li H, Liu F, Bai Y, Shan B, Xu L, Xu X. Delineation of early and later adult onset depression by diffusion tensor imaging. PLoS One. 2014 Nov 13;9(11):e112307. doi: 10.1371/journal.pone.0112307. eCollection 2014.
PubMed 25393297Xu J, Cheng Y, Chai P, Lu Z, Li H, Luo C, Li X, Li L, Zhou Q, Chen B, Cao J, Xu X, Shan B, Xu L, Wen J. White-matter volume reduction and the protective effect of immunosuppressive therapy in systemic lupus erythematosus patients with normal appearance by conventional magnetic resonance imaging. J Rheumatol. 2010 May;37(5):974-86. doi: 10.3899/jrheum.090967. Epub 2010 Mar 15.
PubMed 20231206
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Neuroimaging and Epigenetic Investigation of Antidepressants in Depression
- ClinicalTrials.gov ID
- NCT00703742
- Acronym / sponsor ID
- Kunming MC
- Conditions
- Depression, Depression Secondary to Other Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Kunming Medical UniversityUniversity, hospital or other
- Collaborators
- Chinese Academy of Sciences
- Study start
- Jun 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 23 Jun 2008 (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 find out the structural or functional effects of selective serotonin reuptake inhibitors (SSRI) in major depressive disorder (MDD);
- find special abnormalities in depression secondary to other disease, e.g., autoimmune disease like systemic lupus erythematosus (SLE).
- find the relationship between the efficacy of antidepressant and the change of neuroimaging in MDD
- to find possible predispose to MDD
- to explore the DNA methylation status in depression;
Detailed description
- to explore the pathology of depression
- to identify the difference between MDD and depression secondary to other disease ,especially autoimmune disease
- to explore the effect of gene-environment interaction on the epigenetic regulation of the depression
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A,1 | Experimental | Drug: EscitalopramA: Escitalopram, 20 mg/day,8weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- DSM-IV Major Depression or Dysthymia
- Age 18-65
- Physically healthy
- Drug-free
Key exclusion criteria (8 listed)
- Body metal (e.g., wire stitches, screws in bones, stainless steel hips)
- History of Psychosis or Epilepsy
- Current (past six months) Substance Use Disorder (illicit drugs and/or alcohol)
- Bipolar I
- Need for wash-out from effective treatment in order to participate
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 |
|---|---|---|
| EscitalopramA,1: Escitalopram, oral, 20 mg/day, 8 weeks | Drug | A,1 |
Primary outcome
change of fMRI after medication
Time frame: baseline, 4 weeks, 8 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 17 Sep 2019.
- Derived from this study: PubMed 42349919Yang Y, Tao L, Zhao R, Bai R, Liu S, Zhang G, Li S, Xu X, Cheng Y, Xu J. Influence of sex and systemic lupus erythematosus disease status on cerebral cortex structure. Lupus Sci Med. 2026 Jun 25;13(1):e002032. doi: 10.1136/lupus-2026-002032.
- Derived from this study: PubMed 37270840Chu Z, Yuan L, He M, Cheng Y, Lu Y, Xu X, Shen Z. Atrophy of bilateral nucleus accumbens in melancholic depression. Neuroreport. 2023 Jun 7;34(10):493-500. doi: 10.1097/WNR.0000000000001915. Epub 2023 May 31.
- Derived from this study: PubMed 25393297Cheng Y, Xu J, Yu H, Nie B, Li N, Luo C, Li H, Liu F, Bai Y, Shan B, Xu L, Xu X. Delineation of early and later adult onset depression by diffusion tensor imaging. PLoS One. 2014 Nov 13;9(11):e112307. doi: 10.1371/journal.pone.0112307. eCollection 2014.
- Derived from this study: PubMed 20231206Xu J, Cheng Y, Chai P, Lu Z, Li H, Luo C, Li X, Li L, Zhou Q, Chen B, Cao J, Xu X, Shan B, Xu L, Wen J. White-matter volume reduction and the protective effect of immunosuppressive therapy in systemic lupus erythematosus patients with normal appearance by conventional magnetic resonance imaging. J Rheumatol. 2010 May;37(5):974-86. doi: 10.3899/jrheum.090967. Epub 2010 Mar 15.
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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.
Xu Xiufeng study director
Kunming Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Escitalopram in people with Depression and Depression Secondary to Other Disease, run by Kunming Medical 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 4 inclusion and 8 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 17 Sep 2019. 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?
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?
change of fMRI after medication (time frame: baseline, 4 weeks, 8 weeks). 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 NCT00703742, which also lists 4 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 17 Sep 2019; AzTrials last refreshed its copy on 8 Nov 2026.