participants will be measured twice and all participants are expected to be recruited and measured within 1 year
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
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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
Study Design
Study type: | INTERVENTIONAL |
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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 |
MaskingTRIPLE:
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Clinical Trial Dates
Start date: | Aug 01, 2011 | |
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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
Lead Sponsor:
Medical University of Vienna
Responsible Party:
N/A
Location
Eligibility Criteria
Sex: | All |
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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
* 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
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 |
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Other IDs: | P14193ONB |
Study URL: | https://clinicaltrials.gov/study/NCT01394757 |
Last updated: Sep 29, 2023