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

NCT05840861 | Unknown

• 1 other identifier: PCT 202007
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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

Conditions

Major Depressive Disorder; Bipolar Disorder

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (3)

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

Vortioxetine DRUG

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.

MDD

Quetiapine DRUG

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.

Bipolar

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

15 healthy controls, 22 MDD patients, 22 BD patients

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University

Changsha, Hunan, 410001, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Bipolar Disorder

Interventions

Vortioxetine; Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Bipolar and Related Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Yan Zhang, MD PhD

CONTACT

13807315182; yan.zhang@csu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 23, 2023
• First Posted: May 3, 2023
• Study Start: November 5, 2020
• Primary Completion: August 21, 2023
• Study Completion: September 5, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

CN (1)