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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01394757
Recruitment Status : Completed
First Posted : July 14, 2011
Last Update Posted : December 31, 2013
Information provided by (Responsible Party):
Rupert Lanzenberger, Medical University of Vienna

July 13, 2011
July 14, 2011
December 31, 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 ]
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 ]
Complete list of historical versions of study NCT01394757 on 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) ]
Same as current
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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.

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Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
2010-022772-31 ( EudraCT Number )
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Rupert Lanzenberger, Medical University of Vienna
Medical University of Vienna
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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