EUCTR2022-003279-41-ATRecruitingPhase 1
Investigating N-methyl-d-aspartate (NMDA) receptor alterations in major depressive disorder by brain PET - NMDA receptor alterations depressed healthy
Medical University of Vienna, University Department of Psychiatry and Psychotherapy0 sites60 target enrollmentStarted: February 2, 2023Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •General health based on medical history, physical examination and vital signs at screening.
- •Male and female subjects, age 18 to 55 years
- •Willingness and competence to sign the informed consent form
- •Right-handedness
- •Non-smoker (less than 5 cigarettes per week)
- •Body weight 50-100 kg (BMI 19-26)
- •Depressed Patients
- •DSM-V diagnosis of MDD following SCID I, HDRS29, MADRS and BDI
- •Healthy subjects
- •Mental health based on history and initial screening (HDRS = 8, MADRS = 6 and BDI < 13)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Current or history of psychiatric or neurological disease (other than MDD)
- •Current medical illness requiring treatment (other than MDD)
- •Current or former psychopharmacological treatment within the last 6 months
- •Previous escitalopram intake
- •Hypersensitivity to escitalopram
- •Acute suicidality
- •Pregnancy or currently breastfeeding
- •Current or former substance or alcohol abuse
- •Any contraindication for MRI e.g. (implants, stainless steel graft, claustrophobia)
- •Failure to comply with the study protocol or to follow the instruction of the investigating team
- •Summed radiation exposure in this study and the past 10 years exceeds 30 mSv (limit for 10 years acc. to Austrian Radiation Protection Law Med. Strahlenschutzverordnung 2020, §25 (3)”
Investigators
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