Network Dysfunction, Schizophrenia and Pharmacological Magnetic Resonance Imaging (phMRI)
Primary Purpose
Healthy Volunteers
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Esketamine hydrochloride
Sponsored by

About this trial
This is an interventional basic science trial for Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- general health based on history, physical examination, ECG, laboratory screening and structured clinical interview for DSM-IV(SCID)
- willingness and competence to sign the informed consent form
- aged 18 to 55 years
Exclusion Criteria:
- any medical, psychiatric or neurological illness
- current or former substance abuse
- any implant or stainless steel graft and any other contraindications for MRI
- pregnancy
- first degree relatives with a history of psychiatric illness or substance abuse
- failures to comply with the study protocol or to follow the instructions of the investigating team
- lifetime use of antipsychotic drugs
- treatment with psychotropic agents such as SSRIs within the last 6 months
Sites / Locations
- Department of Psychiatry and Psychotherapy, Medical University of Vienna
Outcomes
Primary Outcome Measures
Ketamine-induced changes in BOLD-activity over time
participants will be measured twice and all participants are expected to be recruited and measured within 1 year
Secondary Outcome Measures
Change of task-induced BOLD-activity by ketamine application
Full Information
NCT ID
NCT01394757
First Posted
July 13, 2011
Last Updated
December 29, 2013
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT01394757
Brief Title
Network Dysfunction, Schizophrenia and Pharmacological Magnetic Resonance Imaging (phMRI)
Official Title
Brain Network Dysfunction as a Model for Schizophrenia: Connectivity Alterations Using Ketamine and Pharmacological Magnetic Resonance Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Alterations of functional brain networks have been frequently demonstrated in schizophrenia, although the exact underlying molecular mechanisms remain unrevealed. Ketamine is known to exert its schizophrenia-like effects through modulation of the glutamatergic system, thus facilitating the investigation of the impact of this specific transmitter system on resting state functional brain networks. The aim of the study is therefore to use pharmacological functional Magnetic Resonance Imaging (phMRI) to examine changes in brain networks involved in schizophrenia in response to ketamine application compared to placebo. 30 healthy subjects (15 females) will be examined twice using a double-blind, placebo-controlled, randomized, crossover, counterbalanced-order design. Resting state fMRI will be investigated before, during and after either placebo or ketamine intravenous infusion for 20 minutes. Prior to the main trial 10 additional participants will be included in an open pilot trial.
Hypothesis: Ketamine application will induce changes in resting state networks previously associated with schizophrenia and in the connectivity of relevant brain regions such as the striatum, thalamus, caudate, hippocampus and amygdala. Furthermore, the application of ketamine will provoke changes in the BOLD-activation in three fMRI paradigms each performed before and after ketamine infusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Esketamine hydrochloride
Other Intervention Name(s)
Ketanest S, Ketamine
Intervention Description
Bolus: 15 mg/kg over 1 minute, followed by a maintenance infusion of 0.25 mg/kg/h for 19 minutes.
Primary Outcome Measure Information:
Title
Ketamine-induced changes in BOLD-activity over time
Description
participants will be measured twice and all participants are expected to be recruited and measured within 1 year
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change of task-induced BOLD-activity by ketamine application
Time Frame
60 minutes (before and after ketamine infusion) at each MRI session (interval between MRI scans: 1 week)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
general health based on history, physical examination, ECG, laboratory screening and structured clinical interview for DSM-IV(SCID)
willingness and competence to sign the informed consent form
aged 18 to 55 years
Exclusion Criteria:
any medical, psychiatric or neurological illness
current or former substance abuse
any implant or stainless steel graft and any other contraindications for MRI
pregnancy
first degree relatives with a history of psychiatric illness or substance abuse
failures to comply with the study protocol or to follow the instructions of the investigating team
lifetime use of antipsychotic drugs
treatment with psychotropic agents such as SSRIs within the last 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rupert Lanzenberger, A/Prof., MD
Organizational Affiliation
Department of Psychiatry and Psychotherapy, Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy, Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Links:
URL
http://www.meduniwien.ac.at/neuroimaging/
Description
Homepage of the Functional Neuroimaging Group, Department of Psychiatry and Psychotherapy, Medical University of Vienna
Learn more about this trial
Network Dysfunction, Schizophrenia and Pharmacological Magnetic Resonance Imaging (phMRI)
We'll reach out to this number within 24 hrs