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Completed

NCT Number: NCT02701933

Effects of Ketamine on Eye Movements, Perception and Brain Function

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Bonn

Bonn, North Rhine-Westphalia, 53111, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

ketamine

Drug

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

Other names: Ketamin Ratiopharm

Saline

Drug

Saline, intravenous infusion

Other names: Kochsalzloesung

Primary outcomes

  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

    Time frame: within 1 hour of start of IV infusion

Secondary outcomes

  1. Psychotomimetic State Inventory (PSI)

    Time frame: 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"

    Time frame: within 1 hour of start of IV infusion

  3. d2 Attention Test, a measure of sustained attention

    Time frame: within 1 hour of start of IV infusion

    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

  4. Recognition memory performance (latencies in ms)

    Time frame: after 5 days of washout period

  5. Recognition memory performance (percent correct responses)

    Time frame: after 5 days of washout period

  6. Smooth pursuit gain (%)

    Time frame: within 1 hour of start of IV infusion

  7. Smooth pursuit root mean square error (RMSE)

    Time frame: within 1 hour of start of IV infusion

  8. Smooth pursuit saccadic frequency (number per second)

    Time frame: within 1 hour of start of IV infusion

  9. Prosaccade latency (ms)

    Time frame: within 1 hour of start of IV infusion

  10. Prosaccade gain (%)

    Time frame: within 1 hour of start of IV infusion

  11. Prosaccade spatial error (%)

    Time frame: within 1 hour of start of IV infusion

  12. Prosaccade velocity (degrees per second)

    Time frame: within 1 hour of start of IV infusion

  13. Prosaccade error rate (%)

    Time frame: within 1 hour of start of IV infusion

  14. Antisaccade latency (ms)

    Time frame: within 1 hour of start of IV infusion

  15. Antisaccade gain (%)

    Time frame: within 1 hour of start of IV infusion

  16. Antisaccade spatial error (%)

    Time frame: within 1 hour of start of IV infusion

  17. Antisaccade velocity (degrees per second)

    Time frame: within 1 hour of start of IV infusion

  18. Antisaccade error rate (%)

    Time frame: within 1 hour of start of IV infusion

Sponsors and collaborators

Lead sponsor

University of Bonn

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 8, 2016
Registry last updated
Mar 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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