Network Dysfunction, Schizophrenia and Pharmacological Magnetic Resonance Imaging (phMRI)
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Purpose
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 | Intervention |
|---|---|
|
Healthy Volunteers |
Drug: Esketamine hydrochloride |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, 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 |
- 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
- 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 ]
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
-
Drug: Esketamine hydrochloride
- Ketanest S
- Ketamine
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: Dietmar Winkler, A/Prof., MD | +43-1-40400-3547 | dietmar.winkler@meduniwien.ac.at |
| Contact: Rupert Lanzenberger, A/Prof., MD | +43-1-40400-3825 | rupert.lanzenberger@meduniwien.ac.at |
| Austria | |
| Department of Psychiatry and Psychotherapy, Medical University of Vienna | Recruiting |
| Vienna, Austria, 1090 | |
| Contact: Rupert Lanzenberger, A/Prof., MD +43-1-40400-3825 rupert.lanzenberger@meduniwien.ac.at | |
| Contact: Anna Hoeflich, MD +43-1-664-800 166 2002 anna.hoeflich@meduniwien.ac.at | |
| Principal Investigator: Rupert Lanzenberger, A/Prof., MD | |
| Principal Investigator: | Rupert Lanzenberger, A/Prof., MD | Department of Psychiatry and Psychotherapy, Medical University of Vienna |
More Information
Additional Information:
No publications provided
| 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 |
| Study First Received: | July 13, 2011 |
| Last Updated: | November 15, 2011 |
| Health Authority: | Austria: Human Research Ethics Committee, Medical University of Vienna Austria: Austrian Agency for Health and Food Safety |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Ketamine Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013