Depression
Conditions
Interventions
Trade Name: Ketamin-hameln
Product Name: Ketamin hameln
Product Code: 32265.00.00
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: KETAMINE
Other descriptive name: KETAMINE HY
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - General health based on medical history and physical examination - Psychiatric health based on structured clinical interview for DSM--5 (SCID) for healthy controls - Major depressive episode (first or recurrent) based on structured clinical interview for DSM- 5 and ICD-10 for patients - Age 18 to 55 years - Right-handedness (due to potential lateralization effects of left-handed subjects) - Willingness and competence to sign the informed consent form. 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 65 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Current or history of neurological disease -Current medical illness requiring treatment -Psychiatric diagnosis for healthy individuals -Psychiatric comorbidity with the exception of anxiety disorders for depressed individuals -Pregnancy or current breastfeeding -Current or former substance abuse -Previous ketamine use in lifetime -Any contraindication for MRI (e.g., MR incompatible implants, etc.) including dental implants causing signal artifacts -Failure to comply with the study protocol or to follow the instruction of the investigating team.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To characterize the effects of ketamine on brain activation and connectivity To characterize the effects of ketamine on hedonic experiences;Secondary Objective: Impact of Ketamine on reward processing and fMRI correlates in depression Impact of Ketamine on sexual arousal and fMRI correlates in depression ;Primary end point(s): 1. BOLD signal: cerebral activation, functional connectivity during aesthetic paradigm 2. resting state functional connectivity 3.fMRI activity 4. Chills, Pleasantness;Timepoint(s) of evaluation of this end point: 1. Study Session 2, 3 2. Study Session 2, 3 3. Study Session 1,2, 3, 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. BOLD signal: cerebral activation, functional connectivity during reward paradigm 2. BOLD signal: cerebral activation, functional connectivity during sexual arousal paradigm;Timepoint(s) of evaluation of this end point: 1. Study Session 2, 3 2. Study Session 2, 3 | — |
Countries
Austria
Contacts
Public ContactSponsor
Rupert Lanzenberger, Department of Psychiatry and Psychotherapy, Medical University of Vienna
Outcome results
None listed