Brain Network Dysfunction as a Model for Schizophrenia: Connectivity Alterations using Ketamine and pharmacological Magnetic Resonance Imaging - Network Dysfunction, Schizophrenia and phMRI

• Conditions: Quantify changes of resting-state functional connectivity in response to Esketamine in healthy volunteers.; MedDRA version: 12.1Level: LLTClassification code 10029817Term: Nuclear magnetic resonance imaging brain

• Registration Number: EUCTR2010-022772-31-AT
• Lead Sponsor: Medizinische Universität Wien, Universitätsklinik für Psychiatrie und Psychotherapie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-02
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-) general health based on history, physical examination, ECG, laboratory screening and structured interview for DSM-IV (SCID)
-) willingness and competence to sign the informed consent form
-) Age 18 to 55
-) right handedness
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-) any medical, psychiatric or neurological disease
-) 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
-) lifetime use of antipsychotic drugs
-) treatment with psychotropic agents such as SSRIs in the last 6 months
-) failures to comply with the study protocol or to follow the instructions of the investigating team

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate time-dependent changes in functional connectivity associated with esketamine, altering glutamatergic signalling between brain areas.;Secondary Objective: To investigate esketamine-induced changes in resting-state functional connectivity compared to placebo.;Primary end point(s): resting-state functional connectivity, BOLD signal.