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

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ClinicalTrials.gov 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

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.

Condition or disease Intervention/treatment
Healthy Volunteers Drug: Esketamine hydrochloride

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Brain Network Dysfunction as a Model for Schizophrenia: Connectivity Alterations Using Ketamine and Pharmacological Magnetic Resonance Imaging
Study Start Date : August 2011
Primary Completion Date : August 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine
U.S. FDA Resources

Intervention Details:
    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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01394757

Department of Psychiatry and Psychotherapy, Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: Rupert Lanzenberger, A/Prof., MD Department of Psychiatry and Psychotherapy, Medical University of Vienna

Additional Information:
Responsible Party: Rupert Lanzenberger, A/Prof. PD Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01394757     History of Changes
Other Study ID Numbers: P14193ONB
2010-022772-31 ( EudraCT Number )
First Posted: July 14, 2011    Key Record Dates
Last Update Posted: December 31, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action