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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02717052
Other study ID # 1643/2014
Secondary ID 2014-003280-38
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 2016
Est. completion date December 31, 2019

Study information

Verified date October 2018
Source Medical University of Vienna
Contact Rupert Lanzenberger, Prof.
Phone 014040035760
Email rupert.lanzenberger@meduniwien.ac.at
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
(S)-ketamine (Main study)
Ketanest® S (Esketaminhydrochlorid) 5mg/ml and 25mg/ml ampoules; Actavis Italy S.P.A./Pfizer Corporation Austria GmbH Dosis: 0.25mg/kg bodyweight i.v. over 40 Minutes (ending 10 minutes before PET measurement)
(S)-ketamine (Pilot II)
Ketanest® S (Esketaminhydrochlorid) 5mg/ml and 25mg/ml ampoules; Actavis Italy S.P.A./Pfizer Corporation Austria GmbH Dosis: 0.10mg/kg bodyweight i.v. bolus applied over 5 minutes (starting 15 minutes before PET measurement) and continuous infusion of 0.30mg/kg bodyweight i.v. applied over the course of 130 minutes.
(R,S)-ketamine (Pilot II)
Ketamin-hameln (Ketaminhydrochlorid) 50mg/ml Ampullen; Hameln Pharma Plus GmbH; Sanova Pharma Dosis: 0.20mg/kg bodyweight i.v. bolus applied over 5 minutes (starting 15 minutes before PET measurement) and continuous infusion of 0.60mg/kg bodyweight applied i.v. over the course of 130 minutes.
Placebo
0.9% saline solution i.v. over 40 Minutes (ending 10 minutes before PET measurement)
Other:
PILOT Study II: PET1
[11C]DASB PET
PILOT Study II: PET2
[11C]DASB PET
Main Study: PET1
[11C]DASB PET
Main Study: PET2
[11C]DASB PET
PILOT Study I: PET1
[11C]DASB PET
PILOT Study I: PET2
[11C]DASB PET
Drug:
(R,S)-ketamine (Pilot I)
Ketamin-hameln (Ketaminhydrochlorid) 50mg/ml Ampullen; Hameln Pharma Plus GmbH; Sanova Pharma Dosis: 0.50mg/kg bodyweight i.v. over 40 Minutes (ending 10 minutes before PET measurement)
(R,S)-ketamine (Pilot III)
Ketamin-hameln (Ketaminhydrochlorid) 50mg/ml Ampullen; Hameln Pharma Plus GmbH; Sanova Pharma Dosis: 0.80mg/kg bodyweight i.v. over 50
Other:
PILOT Study III: PET1
[11C]DASB PET
PILOT Study III: PET2
[11C]DASB PET

Locations

Country Name City State
Austria Department of Psychiatry and Psychotherapy, Medical University of Vienna Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

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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