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

Recruiting

• Conditions: Major Depressive Disorder; Bipolar Disorder
• Interventions: Drug: Vortioxetine; Drug: Quetiapine

• Registration Number: NCT05840861
• Lead Sponsor: Central South University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-05
• Study First Submitted: 2023-04-23
• Study First Submitted QC: 2023-04-23
• Study First Posted: 2023-05-03
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-08
• Last Update Posted: 2023-08-14
• Primary Completion: 2023-08-21
• Study Completion: 2023-09-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MDD	Vortioxetine	Participants with major depressive disorder (MDD), unmedicated and currently depressed to participate in MRI and \[18F\]FPEB PET scans
Bipolar	Quetiapine	Participants with bipolar disorder, unmedicated and currently depressed to participate in MRI and \[18F\]FPEB PET scans

Primary Outcome Measures

Name	Time	Method
Baseline concentration of mGLUR5 availability	Day 0	BPND at baseline as measured by PET
neurite density	baseline and week8	neurite density from Neurite Orientation Dispersion and Density Imaging (NODDI)
Clinical outcome: Number of Participants with remitters and non-remitters	Week 8	Remitters: Hamilton Depression Rating Scale (HAMD-17)≤7, non-remitters: Hamilton Depression Rating Scale (HAMD-17)≥8
functional-connectivity	baseline and week8	functional-connectivity from functional-MRI
Change of Hamilton Depression Rating Scale-17 (HAMD-17) score from baseline to 8 weeks	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
Change in concentration of mGLUR5 availability from baseline to 8 weeks	Week 8	BPND changes from baseline to 8 weeks

Trial Locations

Locations (1)

Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University; 🇨🇳 Changsha, Hunan, China