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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-022772-31-AT
Enrollment
Unknown
Registered
2011-02-02
Start date
2011-02-09
Completion date
Unknown
Last updated
2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Ketanest S 5 mg/ml-Ampullen Pharmaceutical Form: Solution for infusion INN or Proposed INN: Esketamine Hydrochloride CAS Number: 33643-46-8 Other descriptive name: ESKETAMINE HYDROCHLORIDE

Sponsors

Medizinische Universität Wien, Universitätsklinik für Psychiatrie und Psychotherapie
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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.—

Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026