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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05840861
• Other study ID #: PCT 202007
• Status: Recruiting
• Start date: November 5, 2020
• Est. completion date: September 5, 2023

Study information

• Verified date: August 2023
• Source: Central South University
• Contact: Yan Zhang, MD PhD
• Phone: 13807315182
• Email: yan.zhang[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 59
• Est. completion date: September 5, 2023
• Est. primary completion date: August 21, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Mood Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

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