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Status unknownNCT05840861Updated Aug 14, 2023

Using 18F-FPEB PET to Identify mGLUR5 Availability in Affective Disorders

An observational study in Major Depressive Disorder and Bipolar Disorder, sponsored by Central South University. Status unknown at 1 site in China. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-14.

Sponsored by Central South University · Observational

The sponsor has not verified this record recently (last verified Aug 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
59
Ages
18 Years to 35 Years
Sex
All
01

Study 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. 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

02

Conditions studied

  • Major Depressive Disorder
  • Bipolar Disorder
03

In context

Depressive Disorder, Major

2,805 studies on the registry are indexed under Depressive Disorder, Major; 565 are open to participants now.

This study's planned enrollment of 59 is below the median of 135 across 365 observational studies indexed under Depressive Disorder, Major.

Browse Depressive Disorder, Major studies →

Lead sponsor

Central South University is the lead sponsor of 131 studies on the registry; 29 are open to participants now.

Browse Central South University studies →

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

15 healthy controls, 22 MDD patients, 22 BD patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
59 participants (estimated)
Patient registry
No

Groups and cohorts

  • MDD

    Participants with major depressive disorder (MDD), unmedicated and currently depressed to participate in MRI and \[18F\]FPEB PET scans

    Drug: Vortioxetine

  • Bipolar

    Participants with bipolar disorder, unmedicated and currently depressed to participate in MRI and \[18F\]FPEB PET scans

    Drug: Quetiapine

  • Healthy Control

    Healthy participant with no MDD or other psychiatric condition to participate in MRI and \[18F\]FPEB PET scans

Interventions

  • DrugVortioxetine

    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.

  • DrugQuetiapine

    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.

06

What researchers measure

Primary outcomes

  1. Baseline concentration of mGLUR5 availability

    BPND at baseline as measured by PET

    Time frame: Day 0

  2. Change in concentration of mGLUR5 availability from baseline to 8 weeks

    BPND changes from baseline to 8 weeks

    Time frame: Week 8

  3. 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

    Time frame: Week 8

  4. 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

    Time frame: Week 8

  5. functional-connectivity

    functional-connectivity from functional-MRI

    Time frame: baseline and week8

  6. neurite density

    neurite density from Neurite Orientation Dispersion and Density Imaging (NODDI)

    Time frame: baseline and week8

07

Study locations

1 of 1 sites recruiting
  • Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University
    Changsha, Hunan 410001, China
    • Yan Zhang, MD PhD · Contact
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2020 (actual). Primary completion is estimated for Aug 2023, 33 months after the start.

Of 113 non-industry observational studies under Depressive Disorder, Major, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 73. This study's planned 33 months is below that.

Counting every sponsor, half of 138 studies reached it within 39 months; a quarter within 22 and three quarters within 67.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 23, 2023
First posted
May 3, 2023
StartActual
Nov 5, 2020
Primary completionEst.
Aug 21, 2023
CompletionEst.
Sep 5, 2023
Last update
Aug 14, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05840861
Lead sponsor
Central South University
Responsible party
Zhang Yan (Professor, Central South University) — Principal investigator
First posted
May 3, 2023
Start date
Nov 5, 2020
Primary completion
Aug 21, 2023 (estimated)
Completion
Sep 5, 2023 (estimated)
Last update
Aug 14, 2023

Study contacts

Yan Zhang, MD PhD
Contact
yan.zhang@csu.edu.cn
13807315182

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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