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

Sponsor
Central South University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05840861
Collaborator
(none)
59
1
29.8
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
59 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Using 18F-FPEB PET to Identify mGLUR5 Availability in Affective Disorders
Actual Study Start Date :
Nov 5, 2020
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Baseline mGLUR5 availability [Day 0]

    BPND at baseline as measured by PET

  2. Change in mGLUR5 availability from baseline to 8 weeks [Week 8]

    BPND changes from baseline to 8 weeks

  3. Change of Hamilton Depression Rating Scale (HAMD) score from baseline to 8 weeks [Week 8]

    Change of Hamilton Depression Rating Scale (HAMD) score from baseline to 8 weeks

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Meet DSM-V criteria for a current depressive episode.

  • Medication free for at least 4 weeks.

  • Score >21 on 24-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 60.

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University Changsha Hunan China 410001

Sponsors and Collaborators

  • Central South University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhang Yan, Professor, Central South University
ClinicalTrials.gov Identifier:
NCT05840861
Other Study ID Numbers:
  • PCT 202007
First Posted:
May 3, 2023
Last Update Posted:
May 3, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 3, 2023