Healthy VolunteersNCT01394757
Network Dysfunction, Schizophrenia and Pharmacological Magnetic Resonance Imaging (phMRI)
A study testing Esketamine hydrochloride in people with Healthy Volunteers, run by Medical University of Vienna at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Esketamine hydrochloride
- Type of treatment
- Injection or infusion
- How many people
- 52 participants
- Where
- 1 siteAustria
- Study dates
- Aug 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Psychiatry and Psychotherapy, Medical University of Vienna
Vienna, State of Vienna, 1090
About this study
Official title: Brain Network Dysfunction as a Model for Schizophrenia: Connectivity Alterations Using Ketamine and Pharmacological Magnetic Resonance Imaging
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
- Being tested
- Esketamine hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esketamine hydrochlorideDrug
Also called Ketanest S, Ketamine
Bolus: 15 mg/kg over 1 minute, followed by a maintenance infusion of 0.25 mg/kg/h for 19 minutes.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (1)
Change of task-induced BOLD-activity by ketamine application
Measured: 60 minutes (before and after ketamine infusion) at each MRI session (interval between MRI scans: 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rupert Lanzenberger, Medical University of Vienna
- Investigators
- Rupert Lanzenberger, A/Prof., MD, Principal investigator, Department of Psychiatry and Psychotherapy, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394757
- Sponsor's protocol ID
- P14193ONB
- Other IDs
- 2010-022772-31
- Status last verified
- Dec 2013
- First submitted
- 13 Jul 2011
- Last updated
- 31 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Network Dysfunction as a Model for Schizophrenia: Connectivity Alterations Using Ketamine and Pharmacological Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT01394757
- Acronym / sponsor ID
- P14193ONB
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 14 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esketamine hydrochlorideAlso: Ketanest S, KetamineBolus: 15 mg/kg over 1 minute, followed by a maintenance infusion of 0.25 mg/kg/h for 19 minutes. | Drug | – |
Primary outcome
Ketamine-induced changes in BOLD-activity over time
Time frame: 1 year
participants will be measured twice and all participants are expected to be recruited and measured within 1 year
1 secondary outcome
Change of task-induced BOLD-activity by ketamine application
Time frame: 60 minutes (before and after ketamine infusion) at each MRI session (interval between MRI scans: 1 week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2013.
- Homepage of the Functional Neuroimaging Group, Department of Psychiatry and Psychotherapy, Medical University of ViennaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rupert Lanzenberger, A/Prof., MD principal investigator
Department of Psychiatry and Psychotherapy, Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esketamine hydrochloride in people with Healthy Volunteers, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ketamine-induced changes in BOLD-activity over time (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2013; AzTrials last refreshed its copy on 2 Nov 2026.