Effects of Ketamine on Eye Movements, Perception and Brain Function

NCT02701933 | Completed

• 1 other identifier: #14-03-20
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Neuroimaging

Outcome Measures

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

  within 1 hour of start of IV infusion

Secondary Outcomes (18)

• Psychotomimetic State Inventory (PSI)

  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"

  within 1 hour of start of IV infusion

• d2 Attention Test, a measure of sustained attention

  within 1 hour of start of IV infusion

• Recognition memory performance (latencies in ms)

  after 5 days of washout period

• Recognition memory performance (percent correct responses)

  after 5 days of washout period

Study Arms (2)

Ketamine-Saline

OTHER

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; Drug: Saline

Saline-Ketamine

OTHER

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; Drug: Saline

Interventions

Ketamine DRUG

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

Also known as: Ketamin Ratiopharm

Ketamine-Saline; Saline-Ketamine

Saline DRUG

Saline, intravenous infusion

Also known as: Kochsalzloesung

Ketamine-Saline; Saline-Ketamine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bonn: lead

Study Sites (1)

University of Bonn

Bonn, North Rhine-Westphalia, 53111, Germany

Location

MeSH Terms

Interventions

Ketamine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ulrich Ettinger, PhD

  Department of Psychology, University of Bonn

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: March 8, 2016
• Study Start: April 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 8, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)