Positron Emission Tomography Assessment of Ketamine Binding of the Serotonin Transporter

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.

Intervention / Treatment

  • Drug: (S)-ketamine (Main study)
  • Drug: (S)-ketamine (Pilot II)
  • Drug: (R,S)-ketamine (Pilot II)
  • Drug: Placebo
  • Other: PILOT Study II: PET1
  • Other: PILOT Study II: PET2
  • Other: Main Study: PET1
  • Other: Main Study: PET2
  • Other: PILOT Study I: PET1
  • Other: PILOT Study I: PET2
  • Drug: (R,S)-ketamine (Pilot I)
  • Drug: (R,S)-ketamine (Pilot III)
  • Other: PILOT Study III: PET1
  • Other: PILOT Study III: PET2

Condition or Disease

  • Depression
  • Ketamine

Phase

Study Design

Study type: Interventional
Status: Recruiting
Study results: No Results Available
Age: 18 Years to 55 Years   (Adult)
Enrollment: 74 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: May 16, 2020
Primary Completion: Dec 31, 2019
Completion Date: Dec 31, 2019
Study First Posted: Mar 23, 2016
Results First Posted: Aug 31, 2020
Last Updated: Oct 15, 2018

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Location

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

Sex: All
Minimum Age: 18
Maximum Age: 55

This clinical trial is recruiting

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More Details

NCT Number: NCT02717052
Other IDs: 1643/2014|2014-003280-38
Study URL: https://ClinicalTrials.gov/show/NCT02717052
Last updated: Jun 17, 2022