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

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.

Intervention / Treatment

  • esketamine hydrochloride (DRUG)
    Bolus: 15 mg/kg over 1 minute, followed by a maintenance infusion of 0.25 mg/kg/h for 19 minutes.

Condition or Disease

  • Healthy Volunteers

Phase

  • Not Applicable
  • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 55 Years
    Enrollment: 52 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Basic Science

    Masking

    TRIPLE:
    • Participant
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Aug 01, 2011
    Primary Completion: Aug 01, 2012 ACTUAL
    Completion Date: Aug 01, 2012 ACTUAL
    Study First Posted: Jul 14, 2011 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Dec 29, 2013

    Sponsors / Collaborators

    Responsible Party: N/A

    Location

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 55
    Age Groups: Adult
    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

    Primary Outcomes
    • participants will be measured twice and all participants are expected to be recruited and measured within 1 year

    Secondary Outcomes
    • Change of task-induced BOLD-activity by ketamine application 60 minutes (before and after ketamine infusion) at each MRI session (interval between MRI scans: 1 week)

    More Details

    NCT Number: NCT01394757
    Other IDs: P14193ONB
    Study URL: https://clinicaltrials.gov/study/NCT01394757
    Last updated: Sep 29, 2023