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Effects of Ketamine on Eye Movements, Perception and Brain Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 17, 2016
First Posted Date  ICMJE March 8, 2016
Last Update Posted Date March 8, 2016
Study Start Date  ICMJE April 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2016)
  • Psychotomimetic State Inventory (PSI) [ Time Frame: within 1 hour of start of IV infusion ]
  • 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 ]
  • 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
  • Recognition memory performance (latencies in ms) [ Time Frame: after 5 days of washout period ]
  • Recognition memory performance (percent correct responses) [ Time Frame: after 5 days of washout period ]
  • Smooth pursuit gain (%) [ Time Frame: within 1 hour of start of IV infusion ]
  • Smooth pursuit root mean square error (RMSE) [ Time Frame: within 1 hour of start of IV infusion ]
  • Smooth pursuit saccadic frequency (number per second) [ Time Frame: within 1 hour of start of IV infusion ]
  • Prosaccade latency (ms) [ Time Frame: within 1 hour of start of IV infusion ]
  • Prosaccade gain (%) [ Time Frame: within 1 hour of start of IV infusion ]
  • Prosaccade spatial error (%) [ Time Frame: within 1 hour of start of IV infusion ]
  • Prosaccade velocity (degrees per second) [ Time Frame: within 1 hour of start of IV infusion ]
  • Prosaccade error rate (%) [ Time Frame: within 1 hour of start of IV infusion ]
  • Antisaccade latency (ms) [ Time Frame: within 1 hour of start of IV infusion ]
  • Antisaccade gain (%) [ Time Frame: within 1 hour of start of IV infusion ]
  • Antisaccade spatial error (%) [ Time Frame: within 1 hour of start of IV infusion ]
  • Antisaccade velocity (degrees per second) [ Time Frame: within 1 hour of start of IV infusion ]
  • Antisaccade error rate (%) [ Time Frame: within 1 hour of start of IV infusion ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Ketamine on Eye Movements, Perception and Brain Function
Official Title  ICMJE Effects of Ketamine on Eye Movements, Perception and Brain Function
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Functional Neuroimaging
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Ketamine
    • Drug: Saline
  • 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.
    Interventions:
    • Drug: Ketamine
    • Drug: Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2016)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02701933
Other Study ID Numbers  ICMJE #14-03-20
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ulrich Ettinger, University of Bonn
Study Sponsor  ICMJE University of Bonn
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ulrich Ettinger, PhD Department of Psychology, University of Bonn
PRS Account University of Bonn
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP