Clinical trial NCT02717052: Positron Emission Tomography Assessment of Ketamine Binding of the Serotonin Transporter
Official title: Positron Emission Tomography Assessment of Ketamine Binding of the Serotonin Transporter and Its Relevance for Rapid Antidepressant Response
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Depression
Ketamine
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot I and Pilot III not randomised
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Intravenous application of ketamine is currently dramatically gaining in significance as a rapid and highly effective antidepressant treatment option. Ketamine modulates various neurotransmitter systems, though the mechanisms responsible for its antidepressant effects remain unkownn. However, the serotonin transporter (SERT) presents a target of high interest due to the SERT's fundamental role in depression's pathophysiology as well as in 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. Further, investigation of severely depressed patients provides the unique opportunity to establish the relationship between ketamine's SERT binding and its antidepressant efficacy.

Eligibility criteria: 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)

Primary outcomes:
measure: Pilot Study II: (S)-ketamine SERT occupancy assessed with DASB binding potential (BP)
timeFrame: during PET/during 135 minutes of infusion
measure: Pilot Study II: (R,S)-ketamine SERT occupancy assessed with DASB binding potential (BP)
timeFrame: during PET/during 135 minutes of infusion
measure: Main Study: (S)-ketamine SERT occupancy assessed with DASB binding potential (BP)
timeFrame: during PET/starting 10 minutes afer 40 minutes of infusion
measure: Pilot Study I: (R,S)-ketamine SERT occupancy assessed with DASB binding potential (BP)
timeFrame: during PET/starting 10 minutes afer 40 minutes of infusion
measure: Pilot Study III: (R,S)-ketamine SERT occupancy assessed with DASB binding potential (BP)
timeFrame: during PET
measure: Pilot Study III: resting state MRI
timeFrame: after PET 2
measure: Pilot Study III: MRS
timeFrame: after PET 2
Secondary outcomes:
measure: Change in Hamilton Depression Rating Scale Points
timeFrame: 2 hours after infusion to baseline
measure: Change in Hamilton Depression Rating Scale Points
timeFrame: 1 day after infusion to baseline
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Psychiatry and Psychotherapy, Medical University of Vienna
Study officials:
affiliation: Department of Psychiatry and Psychotherapy, Medical University of Vienna
name: Rupert Lanzenberger, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spies M, James GM, Berroteran-Infante N, Ibeschitz H, Kranz GS, Unterholzner J, Godbersen M, Gryglewski G, Hienert M, Jungwirth J, Pichler V, Reiter B, Silberbauer L, Winkler D, Mitterhauser M, Stimpfl T, Hacker M, Kasper S, Lanzenberger R. Assessment of Ketamine Binding of the Serotonin Transporter in Humans with Positron Emission Tomography. Int J Neuropsychopharmacol. 2018 Feb 1;21(2):145-153. doi: 10.1093/ijnp/pyx085.