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

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 Overview

• Status: Recruiting
• Conditions: Bipolar Disorder; Major Depressive Disorder
• Intervention / Treatment: Drug: Vortioxetine; Drug: Quetiapine

• Study Type: Observational
• Enrollment (Estimated): 59

Contacts and Locations

• Study Contact: Name: Yan Zhang, MD PhD; Phone Number: 13807315182; Email: yan.zhang@csu.edu.cn

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

15 healthy controls, 22 MDD patients, 22 BD patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MDD; Participants with major depressive disorder (MDD), unmedicated and currently depressed to participate in MRI and [18F]FPEB PET scans	Drug: Vortioxetine; 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.
Bipolar; Participants with bipolar disorder, unmedicated and currently depressed to participate in MRI and [18F]FPEB PET scans	Drug: Quetiapine; 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.
Healthy Control; Healthy participant with no MDD or other psychiatric condition to participate in MRI and [18F]FPEB PET scans

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline concentration of mGLUR5 availability	BPND at baseline as measured by PET	Day 0
Change in concentration of mGLUR5 availability from baseline to 8 weeks	BPND changes from baseline to 8 weeks	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	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	Week 8
functional-connectivity	functional-connectivity from functional-MRI	baseline and week8
neurite density	neurite density from Neurite Orientation Dispersion and Density Imaging (NODDI)	baseline and week8

Collaborators and Investigators

• Sponsor: Central South University

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2020
• Primary Completion (Estimated): August 21, 2023
• Study Completion (Estimated): September 5, 2023

Study Registration Dates

• First Submitted: April 23, 2023
• First Submitted That Met QC Criteria: April 23, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 8, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Bipolar and Related Disorders; Depressive Disorder; Bipolar Disorder; Mood Disorders; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin Antagonists; Anti-Anxiety Agents; Serotonin 5-HT3 Receptor Antagonists; Selective Serotonin Reuptake Inhibitors; Vortioxetine; Quetiapine Fumarate
• Other Study ID Numbers: PCT 202007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No