Cognitive SymptomPhase 1NCT03469089
Touchscreen-based Cognitive Tests in Healthy Volunteers
A Phase 1 study testing Ketamine 0.58, Ketamine 0.31 and Modafinil in people with Cognitive Symptom and Schizophrenia, run by University of Eastern Finland at 1 site in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cognitive Symptom, Schizophrenia
- What is being tested?
- Ketamine 0.58, Ketamine 0.31 and Modafinil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteFinland
- Study dates
- 12 Mar 2018to 31 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site
University of Eastern Finland, Clinical Research Centre, Brain Research Unit
Kuopio, 70210
About this study
Official title: 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.
Read the 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.
- Conditions
- Cognitive Symptom, Schizophrenia
- Being tested
- Ketamine 0.58, Ketamine 0.31, Modafinil, Placebo for ketamine, Placebo for modafinil
- Keywords
- schizophrenia, cognitive symptom, healthy volunteer, cognitive testing
- Medical subject headings
- Neurobehavioral Manifestations, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine 0.58Drug
Also called Ketalar
Ketamine (0.23 mg/kg bolus + 0.58 mg/kg/h)
Ketamine 0.31Drug
Also called Ketalar
Ketamine (0.12 mg/kg bolus + 0.31 mg/kg/h)
ModafinilDrug
Also called Modafinil Orion
Modafinil tablet 100 mg placed in a capsule
Placebo for ketamineDrug
Also called Placebo
0.9 % NaCl infusion solution
Placebo for modafinilDrug
Also called Placebo
Placebo capsule for modafinil capsule
| Study group | Role | What they receive |
|---|---|---|
| Placebo/placebo | Placebo comparator | Placebo for ketamine (0.9% NaCl) + Placebo for modafinil (microcrystalline cellulose capsule) Receives: Drug: Placebo for ketamine; Drug: Placebo for modafinil |
| Ketamine 0.58/placebo | Experimental | Ketamine (0.23 mg/kg + 0.58 mg/kg/h) + Placebo for modafinil Receives: Drug: Ketamine 0.58; Drug: Placebo for modafinil |
| Ketamine 0.58/modafinil | Experimental | Ketamine (0.23 mg/kg + 0.58 mg/kg/h) + Modafinil (200 mg) Receives: Drug: Ketamine 0.58; Drug: Modafinil |
| Ketamine 0.31/placebo | Experimental | Ketamine (0.12 mg/kg + 0.31 mg/kg/h) + Placebo for modafinil Receives: Drug: Ketamine 0.31; Drug: Placebo for modafinil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ketamine-induced cognitive deficits
Ketamine-induced cognitive deficits are measured by using the touchscreen cognitive test battery
Measured: 15-60 min after initiation of ketamine or placebo infusion
Secondary outcomes (1)
Effect of modafinil on ketamine-induced cognitive deficits
The effect of modafinil on ketamine-induced cognitive deficits are measured by using the touchscreen cognitive test battery
Measured: 15-60 min after initiation of ketamine or placebo infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start12 Mar 2018
- Primary completion16 May 2018
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive SymptomStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All subjects will get each treatment according to balanced latin square design for four treatments with 12 days intervals
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus M Forsberg, PhD, Study director, University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469089
- Sponsor's protocol ID
- REVISE28347
- Other IDs
- 2017-004455-22, 2017
- Status last verified
- Oct 2018
- First submitted
- 12 Mar 2018
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Touchscreen-based Cognitive Tests in Assessment of Ketamine-induced Cognitive Deficits in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03469089
- Acronym / sponsor ID
- REVISE28347
- Conditions
- Cognitive Symptom, Schizophrenia
- Keywords
- schizophrenia, cognitive symptom, healthy volunteer, cognitive testing
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 16 May 2018 (actual)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 19 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- All subjects will get each treatment according to balanced latin square design for four treatments with 12 days intervals
| Arm | Type | Receives |
|---|---|---|
| Placebo/placebo | Placebo comparator | Drug: Placebo for ketamine, Drug: Placebo for modafinilPlacebo for ketamine (0.9% NaCl) + Placebo for modafinil (microcrystalline cellulose capsule) |
| Ketamine 0.58/placebo | Experimental | Drug: Ketamine 0.58, Drug: Placebo for modafinilKetamine (0.23 mg/kg + 0.58 mg/kg/h) + Placebo for modafinil |
| Ketamine 0.58/modafinil | Experimental | Drug: Ketamine 0.58, Drug: ModafinilKetamine (0.23 mg/kg + 0.58 mg/kg/h) + Modafinil (200 mg) |
| Ketamine 0.31/placebo | Experimental | Drug: Ketamine 0.31, Drug: Placebo for modafinilKetamine (0.12 mg/kg + 0.31 mg/kg/h) + Placebo for modafinil |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine 0.58Also: KetalarKetamine (0.23 mg/kg bolus + 0.58 mg/kg/h) | Drug | Ketamine 0.58/modafinil, Ketamine 0.58/placebo |
| Ketamine 0.31Also: KetalarKetamine (0.12 mg/kg bolus + 0.31 mg/kg/h) | Drug | Ketamine 0.31/placebo |
| ModafinilAlso: Modafinil OrionModafinil tablet 100 mg placed in a capsule | Drug | Ketamine 0.58/modafinil |
| Placebo for ketamineAlso: Placebo0.9 % NaCl infusion solution | Drug | Placebo/placebo |
| Placebo for modafinilAlso: PlaceboPlacebo capsule for modafinil capsule | Drug | Ketamine 0.31/placebo, Ketamine 0.58/placebo, Placebo/placebo |
Primary outcome
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
1 secondary outcome
Effect of modafinil on ketamine-induced cognitive deficits
Time frame: 15-60 min after initiation of ketamine or placebo infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus M Forsberg, PhD study director
University of Eastern Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ketamine 0.58, Ketamine 0.31 and Modafinil in people with Cognitive Symptom and Schizophrenia, run by University of Eastern Finland at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ketamine-induced cognitive deficits (time frame: 15-60 min after initiation of ketamine or placebo infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018; AzTrials last refreshed its copy on 28 Oct 2026.