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

NCT01394757 | Completed

• 2 other identifiers: P14193ONB2010-022772-31
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Ketamine-induced changes in BOLD-activity over time

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

  1 year

Secondary Outcomes (1)

• 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)

Interventions

Esketamine hydrochloride DRUG

Bolus: 15 mg/kg over 1 minute, followed by a maintenance infusion of 0.25 mg/kg/h for 19 minutes.

Also known as: Ketanest S, Ketamine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Psychiatry and Psychotherapy, Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

Related Links

• Homepage of the Functional Neuroimaging Group, Department of Psychiatry and Psychotherapy, Medical University of Vienna

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Rupert Lanzenberger, A/Prof., MD

  Department of Psychiatry and Psychotherapy, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A/Prof. PD Dr.

Study Record Dates

• First Submitted: July 13, 2011
• First Posted: July 14, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: December 31, 2013

Record last verified: 2013-12

Locations

AU (1)