Major Depressive DisorderEarly Phase 1NCT03623711
A Prediction Study of Multiple Indexes of the Effect of Different Mechanisms of Antidepressants Treatment on Depression
A Early Phase 1 study testing Escitalopram, Duloxetine and Bupropion in people with Major Depressive Disorder and Depression, Unipolar, run by Yuqi Cheng at 1 site in China.
Trial summary
Antidepressants is the primary treatment for depression, but only less than 50% of the patients get clinical remission. There is no objective markers to select antidepressants for clinical treatment . Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Depression, Unipolar
- What is being tested?
- Escitalopram, Duloxetine and Bupropion
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 31 Dec 2022
- Phase
- Early Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnostic and Statistical Manual (DSM)-IV Major Depression or Dysthymia
- Age 18-60
- Physically healthy
- The score of Hamilton Depression Rating Scale (HAMD)≥18 points
- 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 or breastfeeding
Show all 9Show fewer
- High suicide risk
- Currently taking (within 2 weeks; 4 weeks for Fluoxetine) antidepressants
- have received regular treatment of electric convulsions, repetitive transcranial magnetic stimulation (rTMS), or systematic psychotherapy within three months
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
Yuqi Cheng, PhD, +86-0871-65324888, yuqicheng@126.com
Yuqi Cheng, 13888122013, yuqicheng@126.com
About this study
Antidepressants is the primary treatment for depression, but only less than 50% of the patients get clinical remission. There is no objective markers to select antidepressants for clinical treatment . Clinical choose usually use experience and waste a lot of time, even the patients cannot be treated timely and effectively. The investigators found that the later antidepressant effect for 8 weeks is related with early brain functional response. Present prospectively drug treatment and follow-up study intends to adopt pharmacological imaging research methods to detect the brain function or structure change of three different mechanisms of antidepressant drugs, selective serotonin reuptake inhibitors (SSRIs, escitalopram), serotonin and norepinephrine reuptake inhibitors (SNRIs, duloxetine), norepinephrine and dopamine reuptake inhibitors (NDRIs, bupropion) in depression patients. Brain functional or structural magnetic resonance imaging data were collected at baseline, 1 days, 14 days and 12 weeks after treatment. The investigators want to observe the changes of brain functional networks and structure at different time points, acute and chronic treatment induced during drug treatment. Combined with the blood concentration detection, symptom change, cognitive function tests, the investigators also hope to determine the different mechanisms of drug efficacy of antidepressants with different mechanisms. The second aim is to explore different mechanisms of brain function for effective or ineffective drug response. The results of the study will help to further explain the mechanism of different antidepressants, to facilitate the development of early indicators for drug efficacy and individual treatment decision.
Read the detailed description
about 150 depression patients were divided into three subgroups, for each group was treated by one antidepressant eg.escitalopram,duloxetine,bupropion.Brain magnetic resonance imaging data were conducted for all patients at baseline, 1 days, 14 days and 12 weeks after treatment. The blood concentration detection, symptom change, cognitive function tests were also conducted. combined with these results the investigators aim to determine the different mechanisms of drug efficacy of antidepressants with different mechanisms and to explore different mechanisms of brain function for effective or ineffective drug response
- Conditions
- Major Depressive Disorder, Depression, Unipolar
- Being tested
- Escitalopram, Duloxetine, Bupropion, Healthy control
- Keywords
- major depressive disorder, Magnetic Resonance Imaging, Antidepressant Treatment
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Also called Lexapro
participants take escitalopram tablets based on their severity of depression (10-20mg/day) at least for 12 weeks.
DuloxetineDrug
Also called cymbalta
participants take Duloxetine capsule based on their severity of depression (60mg/day) at least for 12 weeks.
BupropionDrug
Also called bupropion hydrochloride tablets
participants take Bupropion tablets based on their severity of depression (75-300mg/day) at least for 12 weeks.
Healthy controlOther
Also called placebo tablets
Healthy control take placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Escitalopram group | Experimental | including 50 patients, dosage:start 10mg/day and last 2 weeks,we assess the HAMD score at the end of 2 weeks, if the reduction rate of HAMD less than 20% relative to baseline, the dosage add to 20mg/day and last to the end of 12 week. but if the reduction rate of HAMD more than 20% relative to baseline, the investigators will continue to use current dosage until the end of 12 week. Receives: Drug: Escitalopram |
| Duloxetine group | Experimental | including 50 patients, dosage:start 30mg/day and last 2 weeks,we assess the HAMD score at the end of 2 weeks, if the reduction rate of HAMD less than 20% relative to baseline, the dosage add to 60mg/day and last to the end of 12 week. but if the reduction rate of HAMD more than 20% relative to baseline,the investigators will continue to use current dosage until the end of 12 week. Receives: Drug: Duloxetine |
| Bupropion group | Experimental | including 50 patients, dosage:start 75mg/day and last 2 weeks,we assess the HAMD score at the end of 2 weeks, if the reduction rate of HAMD more than 20% relative to baseline, the investigators will continue to use current dosage until the end of 12 week.if the reduction rate of HAMD less than 20% relative to baseline, the dosage add to 150mg/day and last 2 weeks, the investigators assess the HAMD score again, if the reduction rate of HAMD more than 20% relative to baseline, the investigators will continue to use current dosage until the end of 12 week, but if the reduction rate of HAMD still less than 20% relative to baseline, the participants would withdraw. Receives: Drug: Bupropion |
| Healthy control | Placebo comparator | 50 age-, gender-,education level- and handedness matched healthy control would recruit by an advertisement in the local community and school, and excluding ① with a severe physical disease and/or neurological disease, ②with substance abuse, ③ with a history of brain injury, ④ inability to undergo a MRI scan. Receives: Other: Healthy control |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of functional magnetic resonance imaging (fMRI) after medication
change of fMRI after medication
Measured: at baseline, 1 days, 14 days and 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 Aug 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuqi Cheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuqi Cheng, Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623711
- Sponsor's protocol ID
- 81660237
- Status last verified
- Sep 2019
- First submitted
- 14 Jul 2017
- Last updated
- 17 Sep 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 Prediction Study of Multiple Indexes of the Effect of Different Mechanisms of Antidepressants Treatment on Depression
- ClinicalTrials.gov ID
- NCT03623711
- Acronym / sponsor ID
- 81660237
- Conditions
- Major Depressive Disorder, Depression, Unipolar
- Keywords
- major depressive disorder, Magnetic Resonance Imaging, Antidepressant Treatment
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yuqi ChengUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 9 Aug 2018 (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.
Antidepressants is the primary treatment for depression, but only less than 50% of the patients get clinical remission. There is no objective markers to select antidepressants for clinical treatment . Clinical choose usually use experience and waste a lot of time, even the patients cannot be treated timely and effectively. The investigators found that the later antidepressant effect for 8 weeks is related with early brain functional response. Present prospectively drug treatment and follow-up study intends to adopt pharmacological imaging research methods to detect the brain function or structure change of three different mechanisms of antidepressant drugs, selective serotonin reuptake inhibitors (SSRIs, escitalopram), serotonin and norepinephrine reuptake inhibitors (SNRIs, duloxetine), norepinephrine and dopamine reuptake inhibitors (NDRIs, bupropion) in depression patients. Brain functional or structural magnetic resonance imaging data were collected at baseline, 1 days, 14 days and 12 weeks after treatment. The investigators want to observe the changes of brain functional networks and structure at different time points, acute and chronic treatment induced during drug treatment. Combined with the blood concentration detection, symptom change, cognitive function tests, the investigators also hope to determine the different mechanisms of drug efficacy of antidepressants with different mechanisms. The second aim is to explore different mechanisms of brain function for effective or ineffective drug response. The results of the study will help to further explain the mechanism of different antidepressants, to facilitate the development of early indicators for drug efficacy and individual treatment decision.
Detailed description
about 150 depression patients were divided into three subgroups, for each group was treated by one antidepressant eg.escitalopram,duloxetine,bupropion.Brain magnetic resonance imaging data were conducted for all patients at baseline, 1 days, 14 days and 12 weeks after treatment. The blood concentration detection, symptom change, cognitive function tests were also conducted. combined with these results the investigators aim to determine the different mechanisms of drug efficacy of antidepressants with different mechanisms and to explore different mechanisms of brain function for effective or ineffective drug response
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Escitalopram group | Experimental | Drug: Escitalopramincluding 50 patients, dosage:start 10mg/day and last 2 weeks,we assess the HAMD score at the end of 2 weeks, if the reduction rate of HAMD less than 20% relative to baseline, the dosage add to 20mg/day and last to the end of 12 week. but if the reduction rate of HAMD more than 20% relative to baseline, the investigators will continue to use current dosage until the end of 12 week. |
| Duloxetine group | Experimental | Drug: Duloxetineincluding 50 patients, dosage:start 30mg/day and last 2 weeks,we assess the HAMD score at the end of 2 weeks, if the reduction rate of HAMD less than 20% relative to baseline, the dosage add to 60mg/day and last to the end of 12 week. but if the reduction rate of HAMD more than 20% relative to baseline,the investigators will continue to use current dosage until the end of 12 week. |
| Bupropion group | Experimental | Drug: Bupropionincluding 50 patients, dosage:start 75mg/day and last 2 weeks,we assess the HAMD score at the end of 2 weeks, if the reduction rate of HAMD more than 20% relative to baseline, the investigators will continue to use current dosage until the end of 12 week.if the reduction rate of HAMD less than 20% relative to baseline, the dosage add to 150mg/day and last 2 weeks, the investigators assess the HAMD score again, if the reduction rate of HAMD more than 20% relative to baseline, the investigators will continue to use current dosage until the end of 12 week, but if the reduction rate of HAMD still less than 20% relative to baseline, the participants would withdraw. |
| Healthy control | Placebo comparator | Other: Healthy control50 age-, gender-,education level- and handedness matched healthy control would recruit by an advertisement in the local community and school, and excluding ① with a severe physical disease and/or neurological disease, ②with substance abuse, ③ with a history of brain injury, ④ inability to undergo a MRI scan. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnostic and Statistical Manual (DSM)-IV Major Depression or Dysthymia
- Age 18-60
- Physically healthy
- The score of Hamilton Depression Rating Scale (HAMD)≥18 points
- Drug-free
Key exclusion criteria (9 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 |
|---|---|---|
| EscitalopramAlso: Lexaproparticipants take escitalopram tablets based on their severity of depression (10-20mg/day) at least for 12 weeks. | Drug | Escitalopram group |
| DuloxetineAlso: cymbaltaparticipants take Duloxetine capsule based on their severity of depression (60mg/day) at least for 12 weeks. | Drug | Duloxetine group |
| BupropionAlso: bupropion hydrochloride tabletsparticipants take Bupropion tablets based on their severity of depression (75-300mg/day) at least for 12 weeks. | Drug | Bupropion group |
| Healthy controlAlso: placebo tabletsHealthy control take placebo tablets | Other | Healthy control |
Primary outcome
change of functional magnetic resonance imaging (fMRI) after medication
Time frame: at baseline, 1 days, 14 days and 12 weeks after treatment
change of fMRI after medication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- 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?
A Early Phase 1 study testing Escitalopram, Duloxetine and Bupropion in people with Major Depressive Disorder and Depression, Unipolar, run by Yuqi Cheng 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 5 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 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Yuqi Cheng, PhD (13888122013, yuqicheng@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of functional magnetic resonance imaging (fMRI) after medication (time frame: at baseline, 1 days, 14 days and 12 weeks after treatment). 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 17 Sep 2019.