Identifying brain receptor availability in mood disorders
Using 18F-FPEB PET to Identify mGLUR5 Availability in Affective Disorders
This study is testing how a new treatment affects brain receptors in young adults with Major Depressive Disorder or Bipolar Disorder to see if it helps improve their symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 59 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | All |
| Sponsor | Central South University Academic / other |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT05840861 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the availability of metabotropic glutamate receptor 5 (mGLUR5) in patients with Major Depressive Disorder (MDD) and Bipolar Disorder (BD) after two months of treatment with vortioxetine. The researchers hypothesize that abnormal mGLUR5 availability in specific brain regions may correlate with clinical symptoms and prognosis in these mood disorders. The study employs fMRI and NODDI techniques to assess brain function and neurite condition at baseline and after eight weeks of treatment. Participants are first-episode, medication-naïve patients aged 18 to 35 who meet specific diagnostic criteria.
Who should consider this trial
Good fit: Ideal candidates are first-episode, medication-naïve patients aged 18 to 35 with a current depressive episode.
Not a fit: Patients with significant medical or neurological disorders, active suicidal ideation, or those with certain psychiatric diagnoses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of mood disorders and improve treatment strategies based on mGLUR5 availability.
How similar studies have performed: While the specific approach of using mGLUR5 availability in mood disorders is novel, similar studies have explored receptor availability in other psychiatric conditions with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Changsha, Hunan
- Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University — Changsha, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Yan Zhang, MD PhD
- Email: yan.zhang@csu.edu.cn
- Phone: 13807315182
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.