Major Depressive DisorderNCT05840861
Using 18F-FPEB PET to Identify mGLUR5 Availability in Affective Disorders
An observational study of Major Depressive Disorder and Bipolar Disorder, run by Central South University at 1 site in China.
Trial summary
Evidence suggests that mGLUR5 availability may play a key role in the biology of mood disorders. This study aimed to investigate the changes in metabotropic glutamate receptor 5 (mGLUR5) availability and clinical symptoms in patients with MDD and bipolar disorder(BD) after two months of vortioxetine treatment. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Bipolar Disorder
- What is being tested?
- Vortioxetine and Quetiapine
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- 5 Nov 2020to 5 Sep 2023
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 15 healthy controls, 22 MDD patients, 22 BD patients
Who may be able to join
- Meet DSM-V criteria for a current depressive episode.
- Being first-episode patients who were medication-naïve;
- Score >17 on 17-item Hamilton Depression Rating Scale (HDRS), score >22 on Montgomery-Asberg Depression Rating Scale (MADRS), and score <6 on Young Mania Rating Scale (YMRS).
- Age 18 to 35.
- Able to give written informed consent.
Who cannot join
- Have a current or past significant medical, neurological or metabolic disorder or head injury
- Have active, significant suicidal ideation or past suicide attempts
- Have implanted metallic devices or any MR contraindications
- Are women who are pregnant or breastfeeding
- Met DSM-5 criteria for substance use disorder
- Met DSM-5 criteria for any current Axis I diagnosis (except Generalized Anxiety Disorder)
- Are MDD patients present with delusions and/or hallucinations
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University
Changsha, Hunan, 410001
Yan Zhang, MD PhD
About this study
Evidence suggests that mGLUR5 availability may play a key role in the biology of mood disorders. This study aimed to investigate the changes in metabotropic glutamate receptor 5 (mGLUR5) availability and clinical symptoms in patients with MDD and bipolar disorder(BD) after two months of vortioxetine treatment. The investigators hypothesized that patients with MDD and BP have abnormal mGluR5 availability in certain brain regions, and baseline mGLUR5 availability can predict prognosis the prognosis of MDD and BD. fMRI and NODDI are also used to evaluate the function or neurite condition at baseline and 8 week
- Conditions
- Major Depressive Disorder, Bipolar Disorder
- Being tested
- Vortioxetine, Quetiapine
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VortioxetineDrug
All MDD patients will receive 5mg of Vortioxetine per day at the start of this study, which will be gradually increased to 10mg per day within one week.
QuetiapineDrug
All patients with bipolar disorder will receive 50mg of Quetiapine at day 1, 100mg of Quetiapine at day 2, 200mg of Quetiapine at day 3, and 400mg of Quetiapine per day since day 4.
| Study group | Role | What they receive |
|---|---|---|
| MDD | Participants with major depressive disorder (MDD), unmedicated and currently depressed to participate in MRI and [18F]FPEB PET scans Receives: Drug: Vortioxetine | |
| Bipolar | Participants with bipolar disorder, unmedicated and currently depressed to participate in MRI and [18F]FPEB PET scans Receives: Drug: Quetiapine | |
| Healthy Control | Healthy participant with no MDD or other psychiatric condition to participate in MRI and [18F]FPEB PET scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline concentration of mGLUR5 availability
BPND at baseline as measured by PET
Measured: Day 0
Change in concentration of mGLUR5 availability from baseline to 8 weeks
BPND changes from baseline to 8 weeks
Measured: Week 8
Change of Hamilton Depression Rating Scale-17 (HAMD-17) score from baseline to 8 weeks
Change of Hamilton Depression Rating Scale-17 (HAMD-17) score from baseline to 8 weeks, range: 0-51, higher score means more severe symptom of depression
Measured: Week 8
Clinical outcome: Number of Participants with remitters and non-remitters
Remitters: Hamilton Depression Rating Scale (HAMD-17)≤7, non-remitters: Hamilton Depression Rating Scale (HAMD-17)≥8
Measured: Week 8
functional-connectivity
functional-connectivity from functional-MRI
Measured: baseline and week8
neurite density
neurite density from Neurite Orientation Dispersion and Density Imaging (NODDI)
Measured: baseline and week8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start5 Nov 2020
- Primary completion21 Aug 2023 (estimated)
- Study completion5 Sep 2023 (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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Yan, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840861
- Sponsor's protocol ID
- PCT 202007
- Status last verified
- Aug 2023
- First submitted
- 23 Apr 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using 18F-FPEB PET to Identify mGLUR5 Availability in Affective Disorders
- ClinicalTrials.gov ID
- NCT05840861
- Acronym / sponsor ID
- PCT 202007
- Conditions
- Major Depressive Disorder, Bipolar Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 21 Aug 2023 (estimated)
- Study completion
- 5 Sep 2023 (estimated)
- First posted
- 3 May 2023 (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.
Evidence suggests that mGLUR5 availability may play a key role in the biology of mood disorders. This study aimed to investigate the changes in metabotropic glutamate receptor 5 (mGLUR5) availability and clinical symptoms in patients with MDD and bipolar disorder(BD) after two months of vortioxetine treatment. The investigators hypothesized that patients with MDD and BP have abnormal mGluR5 availability in certain brain regions, and baseline mGLUR5 availability can predict prognosis the prognosis of MDD and BD. fMRI and NODDI are also used to evaluate the function or neurite condition at baseline and 8 week
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MDD | – | Drug: VortioxetineParticipants with major depressive disorder (MDD), unmedicated and currently depressed to participate in MRI and [18F]FPEB PET scans |
| Bipolar | – | Drug: QuetiapineParticipants with bipolar disorder, unmedicated and currently depressed to participate in MRI and [18F]FPEB PET scans |
| Healthy Control | – | –Healthy participant with no MDD or other psychiatric condition to participate in MRI and [18F]FPEB PET scans |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 15 healthy controls, 22 MDD patients, 22 BD patients
Key inclusion criteria (5 listed)
- Meet DSM-V criteria for a current depressive episode.
- Being first-episode patients who were medication-naïve;
- Score >17 on 17-item Hamilton Depression Rating Scale (HDRS), score >22 on Montgomery-Asberg Depression Rating Scale (MADRS), and score <6 on Young Mania Rating Scale (YMRS).
- Age 18 to 35.
- Able to give written informed consent.
Key exclusion criteria (7 listed)
- Have a current or past significant medical, neurological or metabolic disorder or head injury
- Have active, significant suicidal ideation or past suicide attempts
- Have implanted metallic devices or any MR contraindications
- Are women who are pregnant or breastfeeding
- Met DSM-5 criteria for substance use disorder
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 |
|---|---|---|
| VortioxetineAll MDD patients will receive 5mg of Vortioxetine per day at the start of this study, which will be gradually increased to 10mg per day within one week. | Drug | MDD |
| QuetiapineAll patients with bipolar disorder will receive 50mg of Quetiapine at day 1, 100mg of Quetiapine at day 2, 200mg of Quetiapine at day 3, and 400mg of Quetiapine per day since day 4. | Drug | Bipolar |
Primary outcome
Baseline concentration of mGLUR5 availability
Time frame: Day 0
BPND at baseline as measured by PET
Change in concentration of mGLUR5 availability from baseline to 8 weeks
Time frame: Week 8
BPND changes from baseline to 8 weeks
Change of Hamilton Depression Rating Scale-17 (HAMD-17) score from baseline to 8 weeks
Time frame: Week 8
Change of Hamilton Depression Rating Scale-17 (HAMD-17) score from baseline to 8 weeks, range: 0-51, higher score means more severe symptom of depression
Clinical outcome: Number of Participants with remitters and non-remitters
Time frame: Week 8
Remitters: Hamilton Depression Rating Scale (HAMD-17)≤7, non-remitters: Hamilton Depression Rating Scale (HAMD-17)≥8
functional-connectivity
Time frame: baseline and week8
functional-connectivity from functional-MRI
neurite density
Time frame: baseline and week8
neurite density from Neurite Orientation Dispersion and Density Imaging (NODDI)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
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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 and Bipolar Disorder, run by Central South 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 5 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 14 Aug 2023. 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 Yan Zhang, MD PhD (13807315182, yan.zhang@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline concentration of mGLUR5 availability (time frame: Day 0). The study lists 6 primary outcomes in all. 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 14 Aug 2023.