Depression Clinical Trial
Official title:
Positron Emission Tomography Assessment of Ketamine Binding of the Serotonin Transporter and Its Relevance for Rapid Antidepressant Response
The study at hand is the first to investigate ketamine's SERT binding in humans, by utilizing the highly selective SERT radioligand [11C]DASB and positron emission tomography.
Status | Recruiting |
Enrollment | 74 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - 18-55 years - somatic health - severe unipolar depression according to DSM-IV (SCID) und HAM-D (for patients) - capable of giving informed consent - negative pregnancy test (females) Exclusion Criteria: - severe somatic illness - psychiatric disorder (for healthy controls) - an axis I comorbidity other than MDD , other than anxiety symptoms (for patients) - clinically relevant alterations in blood draw, ecg, and somatic testing - substance dependency disorder - intake of psychopharmacological medication in last 6 months - first degree relative with Axis 1 disorder (for Pilot I study) |
Country | Name | City | State |
---|---|---|---|
Austria | Department of Psychiatry and Psychotherapy, Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pilot Study II: (S)-ketamine SERT occupancy assessed with DASB binding potential (BP) | Occupancy assessed using kinetic modeling | during PET/during 135 minutes of infusion | |
Primary | Pilot Study II: (R,S)-ketamine SERT occupancy assessed with DASB binding potential (BP) | Occupancy assessed using kinetic modeling | during PET/during 135 minutes of infusion | |
Primary | Main Study: (S)-ketamine SERT occupancy assessed with DASB binding potential (BP) | Occupancy (%)=(1-BPND PET 2 (treatment) / BPND PET 1 (baseline)) x100 | during PET/starting 10 minutes afer 40 minutes of infusion | |
Primary | Pilot Study I: (R,S)-ketamine SERT occupancy assessed with DASB binding potential (BP) | Occupancy (%)=(1-BPND PET 2 (treatment) / BPND PET 1 (baseline)) x100 | during PET/starting 10 minutes afer 40 minutes of infusion | |
Primary | Pilot Study III: (R,S)-ketamine SERT occupancy assessed with DASB binding potential (BP) | Occupancy (%)=(1-BPND PET 2 (treatment) / BPND PET 1 (baseline)) x100 | during PET | |
Primary | Pilot Study III: resting state MRI | changes to rsFC and rsfMRI after (R,S)-ketamine | after PET 2 | |
Primary | Pilot Study III: MRS | changes to Glutamate, GABA, and metabolites after (R,S)-ketami | after PET 2 | |
Secondary | Change in Hamilton Depression Rating Scale Points | 2 hours after infusion to baseline | ||
Secondary | Change in Hamilton Depression Rating Scale Points | 1 day after infusion to baseline |
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