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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05840861
Enrollment
59
Registered
2023-05-03
Start date
2020-11-05
Completion date
2023-09-05
Last updated
2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Major Depressive Disorder

Brief 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

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.

Sponsors

Central South University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes

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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Baseline concentration of mGLUR5 availabilityDay 0BPND at baseline as measured by PET
Change in concentration of mGLUR5 availability from baseline to 8 weeksWeek 8BPND changes from baseline to 8 weeks
Change of Hamilton Depression Rating Scale-17 (HAMD-17) score from baseline to 8 weeksWeek 8Change 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-remittersWeek 8Remitters: Hamilton Depression Rating Scale (HAMD-17)≤7, non-remitters: Hamilton Depression Rating Scale (HAMD-17)≥8
functional-connectivitybaseline and week8functional-connectivity from functional-MRI
neurite densitybaseline and week8neurite density from Neurite Orientation Dispersion and Density Imaging (NODDI)

Countries

China

Contacts

Primary ContactYan Zhang, MD PhD
yan.zhang@csu.edu.cn13807315182

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026