Depressive Disorder, MajorPhase 1DriveSaFe2NCT02919579

A Study to Evaluate the Effects of a Single-Dose and Repeat-Administration of Intranasal Esketamine on On-Road Driving in Participants With Major Depressive Disorder

A Phase 1 study testing Esketamine and Alcohol in people with Depressive Disorder, Major, run by Janssen Research & Development, LLC at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary purpose of this study is to evaluate the effect of a single 84-milligram (mg) dose of intranasal esketamine compared to placebo, on next day driving performance and repeated administration of 84 mg intranasal esketamine on same-day driving performance as assessed by the mean difference of standard… Read more about this study

Who is it for?: Ages 22 to 60 years
Conditions the study is for: Depressive Disorder, Major
What is being tested?: Esketamine and Alcohol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 27 participants
Where: 1 siteNetherlands
Study dates: 7 Oct 2016to 29 Jun 2018
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 22 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Willing and able to adhere to the prohibitions and restrictions specified in this protocol
If a woman, must have a negative serum beta human chorionic gonadotropin pregnancy test at screening and a negative urine pregnancy test on Day 1 of Period 1 in Part A and prior to study drug administration in Part B
Comfortable with self-administration of intranasal medication and able to follow instructions provided
Normal visual acuity (corrected or uncorrected)
Based on self-report, able to consume an amount of alcohol that typically produces a blood alcohol concentration (BAC) of 0.05 percent (that is, 2 to 3 alcoholic drinks ingested within 2 hours on a single occasion)

Who cannot join

Current or prior diagnosis of psychosis/psychotic or bipolar disorder
Primary sleep disorder, such as insomnia, requiring pharmacological intervention at Screening
Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or Day 1 of Period 1 as deemed appropriate by the investigator
Clinically significant abnormal physical examination, vital signs, or 12-lead electrocardiogram (ECG) at screening or Day 1 of Period 1 as deemed appropriate by the investigator
History of moderate or severe use disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV or DSM-5) criteria within 1 year before screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates, cocaine, cannabinoids, amphetamines, and benzodiazepines) at screening and Day 1 of Period 1

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Study site
Leiden

Other trials in Netherlands

About this study

Official title: A Placebo- and Active-Controlled Study to Evaluate the Effects of a Single-Dose and Repeat-Administration of Intranasal Esketamine on On-Road Driving in Subjects With Major Depressive Disorder (DriveSaFe2)

Conditions: Depressive Disorder, Major
Being tested: Placebo (Intranasal), Esketamine, Alcohol, Placebo (Oral)
Medical subject headings: Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Placebo (Intranasal)Drug
Participants will receive intranasal placebo in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.
EsketamineDrug
Participants will receive intranasal esketamine in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.
AlcoholOther
Participants will receive oral alcohol in Part A (as per the treatment sequence in period 1,2 and 3).
Placebo (Oral)Drug
Participants will receive oral placebo in Part A (as per the treatment sequence in period 1,2 and 3).

Study groups in NCT02919579
Study group	Role	What they receive
Part A: Sequence ABC (Placebo+Alcohol+Esketamine)	Experimental	Participants will receive intranasal placebo on Day 1 and oral placebo on Day 2 [Treatment A] in Period 1, then intranasal placebo on Day 1 and Oral alcohol on Day 2 [Treatment B] in Period 2, followed by intranasal esketamine on Day 1 and oral placebo on Day 2 [Treatment C] in Period 3. Receives: Drug: Placebo (Intranasal); Drug: Esketamine; Other: Alcohol; Drug: Placebo (Oral)
Part A: Sequence BCA (Placebo+Alcohol+Esketamine)	Experimental	Participants will receive Treatment B in Period 1, then Treatment C in Period 2, followed by Treatment A in Period 3. Receives: Drug: Placebo (Intranasal); Drug: Esketamine; Other: Alcohol; Drug: Placebo (Oral)
Part A: Sequence CAB (Placebo+Alcohol+Esketamine)	Experimental	Participants will receive Treatment C in Period 1, then Treatment A in Period 2, followed by Treatment B in Period 3. Receives: Drug: Placebo (Intranasal); Drug: Esketamine; Other: Alcohol; Drug: Placebo (Oral)
Part A: Sequence CBA (Placebo+Alcohol+Esketamine)	Experimental	Participants will receive Treatment C in Period 1, then Treatment B in Period 2, followed by Treatment A in Period 3. Receives: Drug: Placebo (Intranasal); Drug: Esketamine; Other: Alcohol; Drug: Placebo (Oral)
Part A: Sequence ACB (Placebo+Alcohol+Esketamine)	Experimental	Participants will receive Treatment A in Period 1, then Treatment C in Period 2, followed by Treatment B in Period 3. Receives: Drug: Placebo (Intranasal); Drug: Esketamine; Other: Alcohol; Drug: Placebo (Oral)
Part A: Sequence BAC (Placebo+Alcohol+Esketamine)	Experimental	Participants will receive Treatment B in Period 1, then Treatment A in Period 2, followed by Treatment C in Period 3. Receives: Drug: Placebo (Intranasal); Drug: Esketamine; Other: Alcohol; Drug: Placebo (Oral)
Part B: Placebo+Esketamine	Experimental	Participants will receive intranasal placebo on Day 1, followed by intranasal esketamine on Days 4, 8, 11, 15, 18, 22 and 25. Receives: Drug: Placebo (Intranasal); Drug: Esketamine

What is being measured

The primary outcome is the main question the study is designed to answer.

The Effect of a Single 84-Milligram (mg) Dose of Intranasal Esketamine Compared to Placebo, on Next day Driving Performance and Repeated Administration of 84 mg Intranasal Esketamine on Same-day Driving Performance
Driving performance will be assessed by the mean difference of standard deviation of lateral position (SDLP) from an on-road driving test.
Measured: Part A: Day 2
The Effect of a Single 84-mg Dose of Intranasal Esketamine Compared to Placebo, on Next day Driving Performance and Repeated Administration of 84 mg Intranasal Esketamine on Same-day Driving Performance
Driving performance will be assessed by the mean difference of standard deviation of lateral position (SDLP) from an on-road driving test.
Measured: Part B: Day 1
The Effect of a Single 84-mg Dose of Intranasal Esketamine Compared to Placebo, on Next day Driving Performance and Repeated Administration of 84 mg Intranasal Esketamine on Same-day Driving Performance
Driving performance will be assessed by the mean difference of standard deviation of lateral position (SDLP) from an on-road driving test.
Measured: Part B: Day 11
The Effect of a Single 84-mg Dose of Intranasal Esketamine Compared to Placebo, on Next day Driving Performance and Repeated Administration of 84 mg Intranasal Esketamine on Same-day Driving Performance
Driving performance will be assessed by the mean difference of standard deviation of lateral position (SDLP) from an on-road driving test.
Measured: Part B: Day 18
The Effect of a Single 84-mg Dose of Intranasal Esketamine Compared to Placebo, on Next day Driving Performance and Repeated Administration of 84 mg Intranasal Esketamine on Same-day Driving Performance
Driving performance will be assessed by the mean difference of standard deviation of lateral position (SDLP) from an on-road driving test.
Measured: Part B: Day 25

Secondary outcomes (9)

Effect on Subjective Driving Ability Scale
Immediately after each driving test, subjects will indicate the perceived quality of their driving performance on a visual analog scale from 0 ('I drove exceptionally poorly') to 20 ('I drove exceptionally well') around a midpoint of 'I drove normally'.
Measured: Part A: Day 2; Part B: Day 1, 11, 18 and 25
Karolinska Sleepiness Scale (KSS) Score
KSS is a participant reported assessment used to rate sleepiness on a scale of 1 to 9, ranging from 'extremely alert' (1) to 'very sleepy, great effort to keep awake, fighting sleep (9).
Measured: Part A: Day 2; Part B: Day 1, 11, 18 and 25
Efficacy Measured by the Montgomery Asberg Depression Rating Scale (MADRS)
MADRS consists of 10 items covering all the important complaints which Participant with depression have (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Item is scored from 0 (normal) to 6 (severe). Total score (0 to 60) is calculated by adding the scores of all 10 items. A higher score represents a more severe condition. Negative Change in Score Indicates Improvement.
Measured: Baseline; Part A: Predose, Day 2; Part B: Predose, Days 1, 11, 18, and 25; End of study (up to Day 98)
Effects on Suicidal Ideation/Behavior Measured by the Columbia Suicide Severity Rating Scale (C-SSRS)
C-SSRS is a clinician rated assessment of suicidal behavior and / or intent. Scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation consists of 5 'yes/no' items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Only items with yes responses are listed. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.
Measured: Baseline; Part A: Predose, Day 2; Part B: Predose, Days 1, 11, 18, and 25; End of study (up to Day 98)
Effects on Dissociative Symptoms Using the Clinician-Administered Dissociative State Scale (CADSS)
The CADSS is an instrument for the measurement of present-state dissociative symptoms. The CADSS comprises 23 subjective items, divided into 3 components: Depersonalization, Derealization and Amnesia. Participant's responses are coded on a 5-point scale (0 = "Not at all" through to 4 = "Extremely").
Measured: Baseline; Part A: Predose, Day 1; Part B: Predose, Days 1, 11, 18, and 25
Potential Relationship Between Changes in SDLP and the Plasma Concentration of Esketamine and Noresketamine
Potential relationship will be assessed using visual displays of data. The relationship between the standard deviation of lateral position (SDLP) and the concentration of esketamine and noresketamine in plasma will be evaluated.
Measured: Part A: 1 hour postdose (Day 1); Part B: 1 hour postdose (Day 11, 18 and 25)
Effect on Subjective Mental Effort Scale
The level of mental effort the participant had to invest in performing the driving test will be assessed on a 15 centimeter (cm) visual analogue scale with markings ranging from 'absolutely no effort' to over 'extreme effort.
Measured: Part A: Day 2; Part B: Day 1, 11, 18 and 25
Potential Relationship Between Changes in Mean Lateral Position (MLP) and the Plasma Concentration of Esketamine and Noresketamine
Potential relationship will be assessed using visual displays of data. The relationship between the MLP and the concentration of esketamine and noresketamine in plasma will be evaluated. The MLP will be measured from a validated on-road driving test in a 100 kilometer (km) highway-driving lane.
Measured: Part A: 1 hour postdose (Day 1); Part B: 1 hour postdose (Day 11, 18 and 25)
Potential Relationship Between Changes in Mean Speed and the Plasma Concentration of Esketamine and Noresketamine
Potential relationship will be assessed using visual displays of data. The relationship between the mean speed (MS) and the concentration of esketamine and noresketamine in plasma will be evaluated. The MS will be measured from a validated on-road driving test in a 100 km highway-driving lane.
Measured: Part A: 1 hour postdose (Day 1); Part B: 1 hour postdose (Day 11, 18 and 25)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Oct 201629 Jun 2018

First posted29 Sep 2016 (estimated)
Study start7 Oct 2016
Primary completion29 Jun 2018
Study completion29 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02919579
Sponsor's protocol ID: CR108228
Other IDs: 2016-002424-86, 54135419TRD1019, 2016
Acronym: DriveSaFe2
Status last verified: Apr 2025
First submitted: 1 Sep 2016
Last updated: 27 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated device: No

Publications

Dijkstra FM, van de Loo AJ, Abdulahad S, Bosma ER, Hartog M, Huls H, Kuijper DC, de Vries E, Solanki B, Singh J, Aluisio L, Zannikos P, Stuurman FE, Jacobs GE, Verster JC. The effects of intranasal esketamine on on-road driving performance in patients with major depressive disorder or persistent depressive disorder. J Psychopharmacol. 2022 May;36(5):614-625. doi: 10.1177/02698811221078764. Epub 2022 Feb 25.
PubMed 35212235

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Placebo- and Active-Controlled Study to Evaluate the Effects of a Single-Dose and Repeat-Administration of Intranasal Esketamine on On-Road Driving in Subjects With Major Depressive Disorder (DriveSaFe2)
ClinicalTrials.gov ID: NCT02919579
Acronym / sponsor ID: DriveSaFe2 / CR108228
Conditions: Depressive Disorder, Major
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: 7 Oct 2016 (actual)
Primary completion: 29 Jun 2018 (actual)
Study completion: 29 Jun 2018 (actual)
First posted: 29 Sep 2016 (estimated)
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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 7

Arm	Type	Receives
Part A: Sequence ABC (Placebo+Alcohol+Esketamine)	Experimental	Drug: Placebo (Intranasal), Drug: Esketamine, Other: Alcohol, Drug: Placebo (Oral)Participants will receive intranasal placebo on Day 1 and oral placebo on Day 2 [Treatment A] in Period 1, then intranasal placebo on Day 1 and Oral alcohol on Day 2 [Treatment B] in Period 2, followed by intranasal esketamine on Day 1 and oral placebo on Day 2 [Treatment C] in Period 3.
Part A: Sequence BCA (Placebo+Alcohol+Esketamine)	Experimental	Drug: Placebo (Intranasal), Drug: Esketamine, Other: Alcohol, Drug: Placebo (Oral)Participants will receive Treatment B in Period 1, then Treatment C in Period 2, followed by Treatment A in Period 3.
Part A: Sequence CAB (Placebo+Alcohol+Esketamine)	Experimental	Drug: Placebo (Intranasal), Drug: Esketamine, Other: Alcohol, Drug: Placebo (Oral)Participants will receive Treatment C in Period 1, then Treatment A in Period 2, followed by Treatment B in Period 3.
Part A: Sequence CBA (Placebo+Alcohol+Esketamine)	Experimental	Drug: Placebo (Intranasal), Drug: Esketamine, Other: Alcohol, Drug: Placebo (Oral)Participants will receive Treatment C in Period 1, then Treatment B in Period 2, followed by Treatment A in Period 3.
Part A: Sequence ACB (Placebo+Alcohol+Esketamine)	Experimental	Drug: Placebo (Intranasal), Drug: Esketamine, Other: Alcohol, Drug: Placebo (Oral)Participants will receive Treatment A in Period 1, then Treatment C in Period 2, followed by Treatment B in Period 3.
Part A: Sequence BAC (Placebo+Alcohol+Esketamine)	Experimental	Drug: Placebo (Intranasal), Drug: Esketamine, Other: Alcohol, Drug: Placebo (Oral)Participants will receive Treatment B in Period 1, then Treatment A in Period 2, followed by Treatment C in Period 3.
Part B: Placebo+Esketamine	Experimental	Drug: Placebo (Intranasal), Drug: EsketamineParticipants will receive intranasal placebo on Day 1, followed by intranasal esketamine on Days 4, 8, 11, 15, 18, 22 and 25.

Who may qualify

Ages: 22 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Willing and able to adhere to the prohibitions and restrictions specified in this protocol
If a woman, must have a negative serum beta human chorionic gonadotropin pregnancy test at screening and a negative urine pregnancy test on Day 1 of Period 1 in Part A and prior to study drug administration in Part B
Comfortable with self-administration of intranasal medication and able to follow instructions provided
Normal visual acuity (corrected or uncorrected)
Based on self-report, able to consume an amount of alcohol that typically produces a blood alcohol concentration (BAC) of 0.05 percent (that is, 2 to 3 alcoholic drinks ingested within 2 hours on a single occasion)

Key exclusion criteria (5 listed)

Current or prior diagnosis of psychosis/psychotic or bipolar disorder
Primary sleep disorder, such as insomnia, requiring pharmacological intervention at Screening
Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or Day 1 of Period 1 as deemed appropriate by the investigator
Clinically significant abnormal physical examination, vital signs, or 12-lead electrocardiogram (ECG) at screening or Day 1 of Period 1 as deemed appropriate by the investigator
History of moderate or severe use disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV or DSM-5) criteria within 1 year before screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates, cocaine, cannabinoids, amphetamines, and benzodiazepines) at screening and Day 1 of Period 1

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
Placebo (Intranasal)Participants will receive intranasal placebo in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.	Drug	Part A: Sequence ABC (Placebo+Alcohol+Esketamine), Part A: Sequence ACB (Placebo+Alcohol+Esketamine), Part A: Sequence BAC (Placebo+Alcohol+Esketamine), Part A: Sequence BCA (Placebo+Alcohol+Esketamine), Part A: Sequence CAB (Placebo+Alcohol+Esketamine), Part A: Sequence CBA (Placebo+Alcohol+Esketamine), Part B: Placebo+Esketamine
EsketamineParticipants will receive intranasal esketamine in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.	Drug	Part A: Sequence ABC (Placebo+Alcohol+Esketamine), Part A: Sequence ACB (Placebo+Alcohol+Esketamine), Part A: Sequence BAC (Placebo+Alcohol+Esketamine), Part A: Sequence BCA (Placebo+Alcohol+Esketamine), Part A: Sequence CAB (Placebo+Alcohol+Esketamine), Part A: Sequence CBA (Placebo+Alcohol+Esketamine), Part B: Placebo+Esketamine
AlcoholParticipants will receive oral alcohol in Part A (as per the treatment sequence in period 1,2 and 3).	Other	Part A: Sequence ABC (Placebo+Alcohol+Esketamine), Part A: Sequence ACB (Placebo+Alcohol+Esketamine), Part A: Sequence BAC (Placebo+Alcohol+Esketamine), Part A: Sequence BCA (Placebo+Alcohol+Esketamine), Part A: Sequence CAB (Placebo+Alcohol+Esketamine), Part A: Sequence CBA (Placebo+Alcohol+Esketamine)
Placebo (Oral)Participants will receive oral placebo in Part A (as per the treatment sequence in period 1,2 and 3).	Drug	Part A: Sequence ABC (Placebo+Alcohol+Esketamine), Part A: Sequence ACB (Placebo+Alcohol+Esketamine), Part A: Sequence BAC (Placebo+Alcohol+Esketamine), Part A: Sequence BCA (Placebo+Alcohol+Esketamine), Part A: Sequence CAB (Placebo+Alcohol+Esketamine), Part A: Sequence CBA (Placebo+Alcohol+Esketamine)

Primary outcome

The Effect of a Single 84-Milligram (mg) Dose of Intranasal Esketamine Compared to Placebo, on Next day Driving Performance and Repeated Administration of 84 mg Intranasal Esketamine on Same-day Driving Performance
Time frame: Part A: Day 2
Driving performance will be assessed by the mean difference of standard deviation of lateral position (SDLP) from an on-road driving test.
The Effect of a Single 84-mg Dose of Intranasal Esketamine Compared to Placebo, on Next day Driving Performance and Repeated Administration of 84 mg Intranasal Esketamine on Same-day Driving Performance
Time frame: Part B: Day 1
Driving performance will be assessed by the mean difference of standard deviation of lateral position (SDLP) from an on-road driving test.
The Effect of a Single 84-mg Dose of Intranasal Esketamine Compared to Placebo, on Next day Driving Performance and Repeated Administration of 84 mg Intranasal Esketamine on Same-day Driving Performance
Time frame: Part B: Day 11
Driving performance will be assessed by the mean difference of standard deviation of lateral position (SDLP) from an on-road driving test.
The Effect of a Single 84-mg Dose of Intranasal Esketamine Compared to Placebo, on Next day Driving Performance and Repeated Administration of 84 mg Intranasal Esketamine on Same-day Driving Performance
Time frame: Part B: Day 18
Driving performance will be assessed by the mean difference of standard deviation of lateral position (SDLP) from an on-road driving test.
The Effect of a Single 84-mg Dose of Intranasal Esketamine Compared to Placebo, on Next day Driving Performance and Repeated Administration of 84 mg Intranasal Esketamine on Same-day Driving Performance
Time frame: Part B: Day 25
Driving performance will be assessed by the mean difference of standard deviation of lateral position (SDLP) from an on-road driving test.

9 secondary outcomes

Effect on Subjective Driving Ability Scale
Time frame: Part A: Day 2; Part B: Day 1, 11, 18 and 25
Karolinska Sleepiness Scale (KSS) Score
Time frame: Part A: Day 2; Part B: Day 1, 11, 18 and 25
Efficacy Measured by the Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: Baseline; Part A: Predose, Day 2; Part B: Predose, Days 1, 11, 18, and 25; End of study (up to Day 98)
Effects on Suicidal Ideation/Behavior Measured by the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline; Part A: Predose, Day 2; Part B: Predose, Days 1, 11, 18, and 25; End of study (up to Day 98)
Effects on Dissociative Symptoms Using the Clinician-Administered Dissociative State Scale (CADSS)
Time frame: Baseline; Part A: Predose, Day 1; Part B: Predose, Days 1, 11, 18, and 25
Potential Relationship Between Changes in SDLP and the Plasma Concentration of Esketamine and Noresketamine
Time frame: Part A: 1 hour postdose (Day 1); Part B: 1 hour postdose (Day 11, 18 and 25)
Effect on Subjective Mental Effort Scale
Time frame: Part A: Day 2; Part B: Day 1, 11, 18 and 25
Potential Relationship Between Changes in Mean Lateral Position (MLP) and the Plasma Concentration of Esketamine and Noresketamine
Time frame: Part A: 1 hour postdose (Day 1); Part B: 1 hour postdose (Day 11, 18 and 25)
Potential Relationship Between Changes in Mean Speed and the Plasma Concentration of Esketamine and Noresketamine
Time frame: Part A: 1 hour postdose (Day 1); Part B: 1 hour postdose (Day 11, 18 and 25)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
Derived from this study: PubMed 35212235Dijkstra FM, van de Loo AJ, Abdulahad S, Bosma ER, Hartog M, Huls H, Kuijper DC, de Vries E, Solanki B, Singh J, Aluisio L, Zannikos P, Stuurman FE, Jacobs GE, Verster JC. The effects of intranasal esketamine on on-road driving performance in patients with major depressive disorder or persistent depressive disorder. J Psychopharmacol. 2022 May;36(5):614-625. doi: 10.1177/02698811221078764. Epub 2022 Feb 25.
A Placebo- and Active-Controlled Study to Evaluate the Effects of a Single-Dose and Repeat-Administration of Intranasal Esketamine on On-Road Driving in Subjects With Major Depressive Disorder (DriveSaFe2)Link provided by the sponsor.

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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.

Janssen Research & Development, LLC Clinical Trial study director

Janssen Research & Development, LLC

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 Esketamine and Alcohol in people with Depressive Disorder, Major, run by Janssen Research & Development, LLC at 1 site in Netherlands.

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 5 inclusion and 5 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: finished, as of the sponsor's last update on 27 Apr 2025. 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 Netherlands. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The Effect of a Single 84-Milligram (mg) Dose of Intranasal Esketamine Compared to Placebo, on Next day Driving Performance and Repeated Administration of 84 mg Intranasal Esketamine on Same-day Driving Performance (time frame: Part A: Day 2). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02919579, which also lists 1 linked publication.

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 27 Apr 2025.