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Functional NeuroimagingNCT02701933

Effects of Ketamine on Eye Movements, Perception and Brain Function

A study testing Ketamine and Saline in people with Functional Neuroimaging, run by University of Bonn at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this study, the investigators examine the effects of low-dose ketamine on different oculomotor, perceptual and cognitive functions. They also examine effects on concurrent brain activity using blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI). Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Functional Neuroimaging
What is being tested?
Ketamine and Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteGermany
Study dates
Apr 2014to Dec 2014
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 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • MRI-suitability
  • suitability for video-based combined pupil and corneal reflection (VCPCR) eye-tracking
  • good command of German language
  • willingness to take part

Who cannot join

  • any current or history of axis I disorder diagnosis as assessed by the Mini-International Neuropsychiatric Interview (M.I.N.I.)
  • any neurological conditions and heart conditions
  • use of any prescription or non-prescription medication up to one week before participation
  • personal history of head-injuries, loss of consciousness, eye surgery or impairment of vision (other than corrective lenses)
  • any other relevant medical conditions such as high blood pressure
  • positive urine drug test (Drug-Screen Multi "5T", nal von minden GmbH)
Show all 9Show fewer
  • history of drug use or current drug use
  • under- or overweight (below 18.5 and above 24.9 body mass index (BMI) values)
  • any diagnosis of psychotic disorders among first-degree relatives

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University of Bonn

    Bonn, North Rhine-Westphalia, 53111

Other trials in Germany

About this study

In this study, the investigators examine the effects of low-dose ketamine on different oculomotor, perceptual and cognitive functions. They also examine effects on concurrent brain activity using blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI). A sample of N=25 healthy, male participants is required to complete the study. The design is within-subjects, placebo-controlled, double-blind and cross-over. A targeted ketamine level in plasma of 100ng/ml is applied. It is hypothesised that ketamine, compared to placebo, will lead to changes in task performance and brain activity similar to those observed in patients with schizophrenia.

Read the detailed description

The uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist ketamine has been proposed as a model system of the symptoms of schizophrenia. To complement this model system and to allow neurobiological as well as translational studies, biomarkers are often applied to people under the influence of ketamine. Here, we apply oculomotor, perceptual and cognitive biomarkers to healthy human volunteers whilst they undergo BOLD fMRI at 3 Tesla field strength. We use a counter-balanced, placebo-controlled, double-blind, within-subjects design. A sample of 25 healthy participants is required. Participants will receive intravenous (IV) racemic ketamine (with a 100ng/ml target plasma concentration) on one of two assessment days and they will receive placebo (intravenous saline) on the other assessment day. BOLD fMRI will be carried out on a Siemens Trio scanner at the Life\&Brain Centre, Bonn. In addition to brain functional and cognitive, perceptual and oculomotor responses, we will also measure self-ratings of psychosis-like experiences. These will be obtained using the Psychotomimetic States Inventory (PSI; Mason et al 2008).

Being tested
Ketamine, Saline

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KetamineDrug

    Also called Ketamin Ratiopharm

    Racemic ketamine, intravenous, at a concentration of 10mg ketamine per 50ml infusion

  • SalineDrug

    Also called Kochsalzloesung

    Saline, intravenous infusion

Study groups in NCT02701933
Study groupRoleWhat they receive
Ketamine-SalineOtherEach participant receives both ketamine and placebo (saline) in randomised order in a repeated-measures design. In this arm, ketamine is administered on the first assessment and placebo (saline) is administered on the second assessment.
Receives: Drug: Ketamine; Drug: Saline
Saline-KetamineOtherEach participant receives both ketamine and placebo (saline) in randomised order in a repeated-measures design. In this arm, placebo (saline) is administered on the first assessment and ketamine is administered on the second assessment.
Receives: Drug: Ketamine; Drug: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Brain activity in cortical and subcortical areas as assessed using BOLD (blood oxygen level dependent) functional magnetic resonance imaging (fMRI) at 3 Tesla field strength

    Measured: within 1 hour of start of IV infusion

Secondary outcomes (18)

  1. Psychotomimetic State Inventory (PSI)

    Measured: within 1 hour of start of IV infusion

  2. Visual Analogue Rating Scales (VARS) from Norris 1971; self-rating scores of the subscales "mental sedation", "physical sedation", "tranquillisation" and "other feelings and attitudes"

    Measured: within 1 hour of start of IV infusion

  3. d2 Attention Test, a measure of sustained attention

    The test requires the crossing out of the letter d combined with two dashes amidst letters d and p combined with one, two, three or four dashes and is a well-established measure of sustained attention

    Measured: within 1 hour of start of IV infusion

  4. Recognition memory performance (latencies in ms)

    Measured: after 5 days of washout period

  5. Recognition memory performance (percent correct responses)

    Measured: after 5 days of washout period

  6. Smooth pursuit gain (%)

    Measured: within 1 hour of start of IV infusion

  7. Smooth pursuit root mean square error (RMSE)

    Measured: within 1 hour of start of IV infusion

  8. Smooth pursuit saccadic frequency (number per second)

    Measured: within 1 hour of start of IV infusion

  9. Prosaccade latency (ms)

    Measured: within 1 hour of start of IV infusion

  10. Prosaccade gain (%)

    Measured: within 1 hour of start of IV infusion

  11. Prosaccade spatial error (%)

    Measured: within 1 hour of start of IV infusion

  12. Prosaccade velocity (degrees per second)

    Measured: within 1 hour of start of IV infusion

  13. Prosaccade error rate (%)

    Measured: within 1 hour of start of IV infusion

  14. Antisaccade latency (ms)

    Measured: within 1 hour of start of IV infusion

  15. Antisaccade gain (%)

    Measured: within 1 hour of start of IV infusion

  16. Antisaccade spatial error (%)

    Measured: within 1 hour of start of IV infusion

  17. Antisaccade velocity (degrees per second)

    Measured: within 1 hour of start of IV infusion

  18. Antisaccade error rate (%)

    Measured: within 1 hour of start of IV infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2016 (estimated)
  2. Study startApr 2014
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

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
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02701933
Sponsor's protocol ID
#14-03-20
Status last verified
Mar 2016
First submitted
17 Feb 2016
Last updated
8 Mar 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Ketamine and Saline in people with Functional Neuroimaging, run by University of Bonn at 1 site in Germany.

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 4 inclusion and 9 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 8 Mar 2016. 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 Germany. 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?

Brain activity in cortical and subcortical areas as assessed using BOLD (blood oxygen level dependent) functional magnetic resonance imaging (fMRI) at 3 Tesla field strength (time frame: within 1 hour of start of IV infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02701933.

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 8 Mar 2016.

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