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Effects of Ketamine on Eye Movements, Perception and Brain Function

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ClinicalTrials.gov Identifier: NCT02701933
Recruitment Status : Completed
First Posted : March 8, 2016
Last Update Posted : March 8, 2016
Sponsor:
Information provided by (Responsible Party):
Ulrich Ettinger, University of Bonn

Study Description
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Brief 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). 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.

Condition or disease Intervention/treatment Phase
Functional Neuroimaging Drug: Ketamine Drug: Saline Not Applicable

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Ketamine on Eye Movements, Perception and Brain Function
Study Start Date : April 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Ketamine-Saline
Each 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.
 Drug: Ketamine
Racemic ketamine, intravenous, at a concentration of 10mg ketamine per 50ml infusion
Other Name: Ketamin Ratiopharm

Drug: Saline
Saline, intravenous infusion
Other Name: Kochsalzloesung
Saline-Ketamine
Each 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.
 Drug: Ketamine
Racemic ketamine, intravenous, at a concentration of 10mg ketamine per 50ml infusion
Other Name: Ketamin Ratiopharm

Drug: Saline
Saline, intravenous infusion
Other Name: Kochsalzloesung


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02701933


Locations
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Germany
University of Bonn
Bonn, NRW, Germany, 53111
Sponsors and Collaborators
University of Bonn
Investigators
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Principal Investigator: Ulrich Ettinger, PhD Department of Psychology, University of Bonn
More Information
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Responsible Party: Ulrich Ettinger, Professor of Psychology, University of Bonn
ClinicalTrials.gov Identifier: NCT02701933    
Other Study ID Numbers: #14-03-20
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
 Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action