Network Dysfunction, Schizophrenia and Pharmacological Ma... | NCT01394757

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

NCT01394757

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Dec 31, 2013Estimated

Enrollment

52Actual

Phase

Not Applicable

Conditions

Healthy Volunteers

Interventions

Esketamine hydrochloride

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2010-022772-31	EudraCT Number

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Aug 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Jul 13, 2011

First Submission Date that Met QC Criteria

Jul 13, 2011

First Posted Date

Jul 14, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2013

Last Update Posted Date

Dec 31, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rupert Lanzenberger, A/Prof. PD Dr., Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Esketamine hydrochloride	Drug	Bolus: 15 mg/kg over 1 minute, followed by a maintenance infusion of 0.25 mg/kg/h for 19 minutes.		Ketanest S Ketamine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rupert Lanzenberger, A/Prof., MD	Department of Psychiatry and Psychotherapy, Medical University of Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Psychiatry and Psychotherapy, Medical University of Vienna		Vienna	State of Vienna	1090	Austria

References Module

Citations

Not provided

ID	Term
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic