Network Dysfunction, Schizophrenia and Pharmacological Magnetic Resonance Imaging (phMRI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rupert Lanzenberger, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01394757
First received: July 13, 2011
Last updated: December 29, 2013
Last verified: December 2013

July 13, 2011
December 29, 2013
August 2011
August 2012   (final data collection date for primary outcome measure)
Ketamine-induced changes in BOLD-activity over time [ Time Frame: 1 year ] [ Designated as safety issue: No ]
participants will be measured twice and all participants are expected to be recruited and measured within 1 year
Ketamine-induced changes in BOLD-activity over time [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01394757 on ClinicalTrials.gov Archive Site
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) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Network Dysfunction, Schizophrenia and Pharmacological Magnetic Resonance Imaging (phMRI)
Brain Network Dysfunction as a Model for Schizophrenia: Connectivity Alterations Using Ketamine and Pharmacological Magnetic Resonance Imaging

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Healthy Volunteers
Drug: Esketamine hydrochloride
Bolus: 15 mg/kg over 1 minute, followed by a maintenance infusion of 0.25 mg/kg/h for 19 minutes.
Other Names:
  • Ketanest S
  • Ketamine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
August 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01394757
P14193ONB, 2010-022772-31
No
Rupert Lanzenberger, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Rupert Lanzenberger, A/Prof., MD Department of Psychiatry and Psychotherapy, Medical University of Vienna
Medical University of Vienna
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP