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

NCT ID: NCT01394757

Last Updated: 2013-12-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Interventions

Esketamine hydrochloride

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

Intervention Type: DRUG

Other Intervention Names

Ketanest S; Ketamine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Rupert Lanzenberger

A/Prof. PD Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rupert Lanzenberger, A/Prof., MD

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry and Psychotherapy, Medical University of Vienna

Locations

Department of Psychiatry and Psychotherapy, Medical University of Vienna

Vienna, Vienna, Austria

Countries

Austria

Related Links

http://www.meduniwien.ac.at/neuroimaging/

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

Other Identifiers

2010-022772-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P14193ONB

Identifier Type: -

Identifier Source: org_study_id