Touchscreen-based Cognitive Tests in Healthy Volunteers

October 15, 2018 updated by: University of Eastern Finland

Touchscreen-based Cognitive Tests in Assessment of Ketamine-induced Cognitive Deficits in Healthy Volunteers

This phase Ib study aims to evaluate applicability of touchscreen-based cognitive test battery for assessment of ketamine-induced schizophrenia-like cognitive deficits in healthy volunteers. Additionally, the study aims to assess whether ketamine-induced cognitive deficits are reversed by modafinil using touchscreen-based test battery for testing of cognition.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Ketamine-induced schizophrenia-like cognitive deficits in healthy volunteers are measured by using touchscreen-based cognitive tests. In addition, the study aims to assess whether ketamine-induced cognitive deficits detected by touchscreen-based cognitive tests are reversed by modafinil.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Kuopio, Finland, 70210
        • University of Eastern Finland, Clinical Research Centre, Brain Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy Caucasian men aged 20-40 years
  • Body weight 50-100 kg
  • Body mass index 19-26 kg/cm2
  • Normal physical examination including heart rate (HR; 50-90/min) blood pressure (BP; diastolic 65-90 and systolic 110-140) normal haematological and clinical chemistry variables normal ECG as judged by the investigator

Exclusion Criteria:

  • Visual disability or red-green color blindness
  • History of mental health disorders as determined by self-reported a) physician-determined diagnoses of mental health disorders, except for nicotine and caffeine dependence, or history of suicide attempt; b) medications for mental health disorders
  • History of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, or neurological disorder
  • History of orthostatic syncope
  • History of head injury with sequelae
  • First-degree relative with a history of psychosis or epilepsy/seizure disorder or of a condition with risk of seizures
  • Current regular medication
  • Vaccination 2 weeks prior to study or during the study
  • Known or suspected allergy/hypersensitivity to any drug
  • History of regular alcohol consumption
  • Current substance dependence (excluding nicotine and caffeine).
  • Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day
  • Use of any medication or alcohol 24 hours before each study visit
  • Education less than high school
  • Clinically relevant symptoms of depression, anxiety or sleep disturbances
  • Donation of blood within 1 month prior to study
  • Participation in any study with an investigational product within 2 months prior to study
  • Clinical signs of suicidal or violent behaviour or psychotic symptoms

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo/placebo
Placebo for ketamine (0.9% NaCl) + Placebo for modafinil (microcrystalline cellulose capsule)
Drug: Placebo for ketamine
0.9 % NaCl infusion solution
Other Names:
  • Placebo
Drug: Placebo for modafinil
Placebo capsule for modafinil capsule
Other Names:
  • Placebo
Experimental: Ketamine 0.58/placebo
Ketamine (0.23 mg/kg + 0.58 mg/kg/h) + Placebo for modafinil
Drug: Placebo for modafinil
Placebo capsule for modafinil capsule
Other Names:
  • Placebo
Drug: Ketamine 0.58
Ketamine (0.23 mg/kg bolus + 0.58 mg/kg/h)
Other Names:
  • Ketalar
Experimental: Ketamine 0.58/modafinil
Ketamine (0.23 mg/kg + 0.58 mg/kg/h) + Modafinil (200 mg)
Drug: Ketamine 0.58
Ketamine (0.23 mg/kg bolus + 0.58 mg/kg/h)
Other Names:
  • Ketalar
Drug: Modafinil
Modafinil tablet 100 mg placed in a capsule
Other Names:
  • Modafinil Orion
Experimental: Ketamine 0.31/placebo
Ketamine (0.12 mg/kg + 0.31 mg/kg/h) + Placebo for modafinil
Drug: Placebo for modafinil
Placebo capsule for modafinil capsule
Other Names:
  • Placebo
Drug: Ketamine 0.31
Ketamine (0.12 mg/kg bolus + 0.31 mg/kg/h)
Other Names:
  • Ketalar

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ketamine-induced cognitive deficits
Time Frame: 15-60 min after initiation of ketamine or placebo infusion
Ketamine-induced cognitive deficits are measured by using the touchscreen cognitive test battery
15-60 min after initiation of ketamine or placebo infusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effect of modafinil on ketamine-induced cognitive deficits
Time Frame: 15-60 min after initiation of ketamine or placebo infusion
The effect of modafinil on ketamine-induced cognitive deficits are measured by using the touchscreen cognitive test battery
15-60 min after initiation of ketamine or placebo infusion

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ketamine plasma levels
Time Frame: 14 and 60 min after initiation of ketamine or placebo infusion
Assessment of ketamine plasma levels
14 and 60 min after initiation of ketamine or placebo infusion
Brain-derived neurotrophic factor serum levels
Time Frame: 14 and 60 min after initiation of ketamine of placebo infusion
Assessment of Brain-derived neurotrophic factor serum levels
14 and 60 min after initiation of ketamine of placebo infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Eastern Finland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Markus M Forsberg, PhD, University of Eastern Finland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 12, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 16, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REVISE28347
  • 2017-004455-22 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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