HealthyPhase 1DRiVESaFeNCT02228239
Study to Assess the Effects of Esketamine on Safety of On-road Driving in Healthy Participants
A Phase 1 study testing Esketamine and Mirtazapine in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Netherlands.
Trial summary
The purpose of this study is to evaluate the effect of esketamine compared to placebo on driving performance as assessed by the mean difference of standard deviation of lateral position (SDLP) from an on-road driving test in healthy participants. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Esketamine and Mirtazapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2014to Dec 2014
- 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) (weight [kg]/height^2[m^2]) between 18 and 30 kg/m^2 (inclusive), and body weight not less than 45 kg
- Blood pressure (after the participants is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at Screening and pre-dose on Day 1 of Period 1
- A woman of childbearing potential must have a negative urine pregnancy test at Screening and pre-dose on Day 1 of Period 1
- A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function at Screening and pre-dose on Day 1 of Period 1, including: sinus rhythm, heart rate between 45 and 90 beats per minute (bpm), QTc interval less than or equal to 450 milliseconds (ms), QRS interval of less than 120 ms, PR interval less than 200 ms and morphology consistent with healthy cardiac conduction and function 1st degree AV block is exclusionary
- Participant has a valid driving license for more than 3 years, has driven at least 5000 kilometer (km) in the past year and is driving a car regularly
Who cannot join
- Participant has clinically significant liver or renal insufficiency; cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic (including cataplexy and cognitive impairment), hematologic, rheumatologic, psychiatric, or metabolic disturbances. A significant primary sleep disorder is exclusionary
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at Screening, as deemed appropriate by the Investigator
- Clinically significant abnormal physical examination, vital signs, or 12-lead electrocardiogram (ECG) at Screening or on Day 1 of Period 1, as deemed appropriate by the Investigator
- Anatomical or medical conditions that may impede delivery or absorption of study medication (for example, undergone facial reconstruction, rhinoplasty, significant structural or functional abnormalities of the nose or upper airway; obstructions or mucosal lesions of the nostrils or nasal passages; undergone sinus surgery in the previous 2 years; or signs and symptoms of rhinitis predose on Day 1 of Period 1)
- Has an abnormal or deviated nasal septum with any one or more of the following symptoms: blockage of one or both nostrils, nasal congestion (especially 1-sided), frequent nosebleeds, frequent sinus infections, and at times has facial pain, headaches, and postnasal drip
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo-Controlled, 3-way Crossover Study to Evaluate the Single Dose Effects of Intranasal Esketamine on Safety of On-Road Driving in Healthy Subjects
The purpose of this study is to evaluate the effect of esketamine compared to placebo on driving performance as assessed by the mean difference of standard deviation of lateral position (SDLP) from an on-road driving test in healthy participants.
Read the detailed description
This is a Phase 1, randomized (study medication assigned to participants by chance), double-blind (neither Investigator nor participant knows which treatment the participant receives), placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), single-center, single-dose and 3-way crossover (the same medications provided to all participants but in different sequence) study of esketamine in healthy participants. Participants will be randomly assigned to 1 of 6 treatment sequences. The study will consist of 3 parts: Screening Phase (between 21 days and 1 day prior to the first dose administration), a 3-way crossover double-blind, single dose treatment Phase (45 days) and follow-up Phase (7 to 10 days after last dose administration). The maximum study duration for each participant will not exceed 7 weeks. Participants will receive either Treatment A (esketamine 84 milligram (mg) intranasal and 1 placebo capsule), Treatment B (placebo intranasal and 1 mirtazapine 30 mg capsule) or Treatment C (placebo intranasal and placebo capsule) in each treatment period. Driving performance will be assessed primarily by the mean difference of SDLP from an on road driving test. Participants' safety will be monitored throughout the study.
- Conditions
- Healthy
- Being tested
- Esketamine, Mirtazapine, Placebo (Matched to Esketamine), Placebo (Matched to Mirtazapine)
- Keywords
- Healthy, Esketamine, Mirtazapine, Psychomotor.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
Also called JNJ-54135419
Esketamine 84 milligram (mg) [3*1 of spray in each nostril] will be administered intranasally on Day 1 in one of the treatment periods.
MirtazapineDrug
Mirtazapine 30 mg capsule will be administered orally on Day 1 in one of the treatment periods.
Placebo (Matched to Esketamine)Drug
Placebo [3*1 in each nostril] will be administered intranasally on Day 1 in one of the treatment periods.
Placebo (Matched to Mirtazapine)Drug
Placebo capsule will be administered orally on Day 1 in one of the treatment periods.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 (ABC) | Experimental | Participants will receive Treatment A (esketamine 84 milligram (mg) intranasally and 1 placebo capsule) in Period 1, Treatment B (placebo intranasally and 1 mirtazapine 30 mg capsule) in Period 2 and Treatment C (placebo intranasally and placebo capsule) in Period 3 with a washout interval of at least 6 days between treatment periods. Receives: Drug: Esketamine; Drug: Mirtazapine; Drug: Placebo (Matched to Esketamine); Drug: Placebo (Matched to Mirtazapine) |
| Sequence 2 (BCA) | Experimental | Participants will receive Treatment B (placebo intranasally and 1 mirtazapine 30 mg capsule) in Period 1, Treatment C (placebo intranasally and placebo capsule) in Period 2 and Treatment A (esketamine 84 mg intranasally and 1 placebo capsule) in Period 3 with a washout interval of at least 6 days between treatment periods. Receives: Drug: Esketamine; Drug: Mirtazapine; Drug: Placebo (Matched to Esketamine); Drug: Placebo (Matched to Mirtazapine) |
| Sequence 3 (CAB) | Experimental | Participants will receive Treatment C (placebo intranasally and placebo capsule) in Period 1, Treatment A (esketamine 84 mg intranasally and 1 placebo capsule) in Period 2 and Treatment B (placebo intranasally and 1 mirtazapine 30 mg capsule) in Period 3 with a washout interval of at least 6 days between treatment periods. Receives: Drug: Esketamine; Drug: Mirtazapine; Drug: Placebo (Matched to Esketamine); Drug: Placebo (Matched to Mirtazapine) |
| Sequence 4 (CBA) | Experimental | Participants will receive Treatment C (placebo intranasally and placebo capsule) in Period 1, Treatment B (placebo intranasally and 1 mirtazapine 30 mg capsule) in Period 2 and Treatment A (esketamine 84 mg intranasally and 1 placebo capsule) in Period 3 with a washout interval of at least 6 days between treatment periods. Receives: Drug: Esketamine; Drug: Mirtazapine; Drug: Placebo (Matched to Esketamine); Drug: Placebo (Matched to Mirtazapine) |
| Sequence 5 (ACB) | Experimental | Participants will receive Treatment A (esketamine 84 mg intranasally and 1 placebo capsule) in Period 1, Treatment C (placebo intranasally and placebo capsule) in Period 2 and Treatment B (placebo intranasally and 1 mirtazapine 30 mg capsule) in Period 3 with a washout interval of at least 6 days between treatment periods. Receives: Drug: Esketamine; Drug: Mirtazapine; Drug: Placebo (Matched to Esketamine); Drug: Placebo (Matched to Mirtazapine) |
| Sequence 6 (BAC) | Experimental | Participants will receive Treatment B (placebo intranasally and 1 mirtazapine 30 mg capsule) in Period 1, Treatment A (esketamine 84 mg intranasally and 1 placebo capsule) in Period 2 and Treatment C (placebo intranasally and placebo capsule) in Period 3 with a washout interval of at least 6 days between treatment periods. Receives: Drug: Esketamine; Drug: Mirtazapine; Drug: Placebo (Matched to Esketamine); Drug: Placebo (Matched to Mirtazapine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard Deviation of Lateral Position (SDLP) Assessed From an On-road Driving Test
The SDLP will be measured from a validated on-road driving test in a 100 kilometer (km) highway-driving lane.
Measured: 4 to 14 hours post-dose
Secondary outcomes (9)
Standard Deviation of Speed (SDS) Assessed From an On-road Driving Test
The SDS will be measured from a validated on-road driving test in a 100 km highway-driving lane.
Measured: 4 to 14 hours post-dose
Mean Speed (MS) Assessed From an On-road Driving Test
The MS will be measured from a validated on-road driving test in a 100 km highway-driving lane.
Measured: 4 to 14 hours post-dose
Mean Lateral Position (MLP) Assessed From an On-road Driving Test
The MLP will be measured from a validated on-road driving test in a 100 km highway-driving lane.
Measured: 4 to 14 hours post-dose
Subjective Driving Performance Score
Participants will indicate the perceived quality of their driving performance on a visual analog scale, which ranges from 0 ('I drove exceptionally poorly') to 20 ('I drove exceptionally well').
Measured: After completion of driving test (4 to 14 hours post-dose)
Karolinska Sleepiness Scale (KSS) Score
The KSS is a participant-reported assessment used to rate sleepiness on a scale of 1 to 9, ranging from 1 (extremely alert) to 9 (very sleepy, great effort to keep awake, fighting sleep).
Measured: Pre-dose, 1, 2 hours and after completion of driving test (4 to 14 hours post-dose)
Columbia Suicide Severity Rating Scale (C-SSRS) Score
The C-SSRS is a low-burden measure of the spectrum of suicidal ideation and behavior developed to assess severity and track suicidal events providing a summary of both suicidal ideation and behavior to identify the level and type of suicidality present.
Measured: Up to 7 to 10 days after last dose administration
Brief Psychiatric Rating Scale (BPRS) Symptom Sub-Scale Score
The BPRS is an 18-item rating scale which is used to assess a range of psychotic and affective symptoms rated from both observation of the participant and the participant's own report. Only the 4-item positive symptom subscale (consisting of: suspiciousness/persecution, hallucinations, unusual thought content, and conceptual disorganization) will be used and each question is rated on a 7-point scale ranging from 0 (not present) to 6 (extremely severe).
Measured: Pre-dose, 1 and 2 hours post-dose
Clinician Administered Dissociative States Scale (CADSS) Score
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: Pre-dose, 1 and 2 hours post-dose
Maximum plasma concentration (Cmax)
The Cmax is the maximum observed plasma concentration of esketamine or noresketamine.
Measured: Pre-dose, 0.5, 1, 3 and 4 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228239
- Sponsor's protocol ID
- CR104764
- Other IDs
- 2014-002005-38, ESKETINTRD1006, 2014
- Acronym
- DRiVESaFe
- Status last verified
- Dec 2014
- First submitted
- 27 Aug 2014
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-Controlled, 3-way Crossover Study to Evaluate the Single Dose Effects of Intranasal Esketamine on Safety of On-Road Driving in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02228239
- Acronym / sponsor ID
- DRiVESaFe / CR104764
- Conditions
- Healthy
- Keywords
- Healthy, Esketamine, Mirtazapine, Psychomotor.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 Aug 2014 (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.
The purpose of this study is to evaluate the effect of esketamine compared to placebo on driving performance as assessed by the mean difference of standard deviation of lateral position (SDLP) from an on-road driving test in healthy participants.
Detailed description
This is a Phase 1, randomized (study medication assigned to participants by chance), double-blind (neither Investigator nor participant knows which treatment the participant receives), placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), single-center, single-dose and 3-way crossover (the same medications provided to all participants but in different sequence) study of esketamine in healthy participants. Participants will be randomly assigned to 1 of 6 treatment sequences. The study will consist of 3 parts: Screening Phase (between 21 days and 1 day prior to the first dose administration), a 3-way crossover double-blind, single dose treatment Phase (45 days) and follow-up Phase (7 to 10 days after last dose administration). The maximum study duration for each participant will not exceed 7 weeks. Participants will receive either Treatment A (esketamine 84 milligram (mg) intranasal and 1 placebo capsule), Treatment B (placebo intranasal and 1 mirtazapine 30 mg capsule) or Treatment C (placebo intranasal and placebo capsule) in each treatment period. Driving performance will be assessed primarily by the mean difference of SDLP from an on road driving test. Participants' safety will be monitored throughout the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 (ABC) | Experimental | Drug: Esketamine, Drug: Mirtazapine, Drug: Placebo (Matched to Esketamine), Drug: Placebo (Matched to Mirtazapine)Participants will receive Treatment A (esketamine 84 milligram (mg) intranasally and 1 placebo capsule) in Period 1, Treatment B (placebo intranasally and 1 mirtazapine 30 mg capsule) in Period 2 and Treatment C (placebo intranasally and placebo capsule) in Period 3 with a washout interval of at least 6 days between treatment periods. |
| Sequence 2 (BCA) | Experimental | Drug: Esketamine, Drug: Mirtazapine, Drug: Placebo (Matched to Esketamine), Drug: Placebo (Matched to Mirtazapine)Participants will receive Treatment B (placebo intranasally and 1 mirtazapine 30 mg capsule) in Period 1, Treatment C (placebo intranasally and placebo capsule) in Period 2 and Treatment A (esketamine 84 mg intranasally and 1 placebo capsule) in Period 3 with a washout interval of at least 6 days between treatment periods. |
| Sequence 3 (CAB) | Experimental | Drug: Esketamine, Drug: Mirtazapine, Drug: Placebo (Matched to Esketamine), Drug: Placebo (Matched to Mirtazapine)Participants will receive Treatment C (placebo intranasally and placebo capsule) in Period 1, Treatment A (esketamine 84 mg intranasally and 1 placebo capsule) in Period 2 and Treatment B (placebo intranasally and 1 mirtazapine 30 mg capsule) in Period 3 with a washout interval of at least 6 days between treatment periods. |
| Sequence 4 (CBA) | Experimental | Drug: Esketamine, Drug: Mirtazapine, Drug: Placebo (Matched to Esketamine), Drug: Placebo (Matched to Mirtazapine)Participants will receive Treatment C (placebo intranasally and placebo capsule) in Period 1, Treatment B (placebo intranasally and 1 mirtazapine 30 mg capsule) in Period 2 and Treatment A (esketamine 84 mg intranasally and 1 placebo capsule) in Period 3 with a washout interval of at least 6 days between treatment periods. |
| Sequence 5 (ACB) | Experimental | Drug: Esketamine, Drug: Mirtazapine, Drug: Placebo (Matched to Esketamine), Drug: Placebo (Matched to Mirtazapine)Participants will receive Treatment A (esketamine 84 mg intranasally and 1 placebo capsule) in Period 1, Treatment C (placebo intranasally and placebo capsule) in Period 2 and Treatment B (placebo intranasally and 1 mirtazapine 30 mg capsule) in Period 3 with a washout interval of at least 6 days between treatment periods. |
| Sequence 6 (BAC) | Experimental | Drug: Esketamine, Drug: Mirtazapine, Drug: Placebo (Matched to Esketamine), Drug: Placebo (Matched to Mirtazapine)Participants will receive Treatment B (placebo intranasally and 1 mirtazapine 30 mg capsule) in Period 1, Treatment A (esketamine 84 mg intranasally and 1 placebo capsule) in Period 2 and Treatment C (placebo intranasally and placebo capsule) in Period 3 with a washout interval of at least 6 days between treatment periods. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body mass index (BMI) (weight [kg]/height^2[m^2]) between 18 and 30 kg/m^2 (inclusive), and body weight not less than 45 kg
- Blood pressure (after the participants is supine for 5 minutes) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at Screening and pre-dose on Day 1 of Period 1
- A woman of childbearing potential must have a negative urine pregnancy test at Screening and pre-dose on Day 1 of Period 1
- A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function at Screening and pre-dose on Day 1 of Period 1, including: sinus rhythm, heart rate between 45 and 90 beats per minute (bpm), QTc interval less than or equal to 450 milliseconds (ms), QRS interval of less than 120 ms, PR interval less than 200 ms and morphology consistent with healthy cardiac conduction and function 1st degree AV block is exclusionary
- Participant has a valid driving license for more than 3 years, has driven at least 5000 kilometer (km) in the past year and is driving a car regularly
Key exclusion criteria (5 listed)
- Participant has clinically significant liver or renal insufficiency; cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic (including cataplexy and cognitive impairment), hematologic, rheumatologic, psychiatric, or metabolic disturbances. A significant primary sleep disorder is exclusionary
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at Screening, as deemed appropriate by the Investigator
- Clinically significant abnormal physical examination, vital signs, or 12-lead electrocardiogram (ECG) at Screening or on Day 1 of Period 1, as deemed appropriate by the Investigator
- Anatomical or medical conditions that may impede delivery or absorption of study medication (for example, undergone facial reconstruction, rhinoplasty, significant structural or functional abnormalities of the nose or upper airway; obstructions or mucosal lesions of the nostrils or nasal passages; undergone sinus surgery in the previous 2 years; or signs and symptoms of rhinitis predose on Day 1 of Period 1)
- Has an abnormal or deviated nasal septum with any one or more of the following symptoms: blockage of one or both nostrils, nasal congestion (especially 1-sided), frequent nosebleeds, frequent sinus infections, and at times has facial pain, headaches, and postnasal drip
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 |
|---|---|---|
| EsketamineAlso: JNJ-54135419Esketamine 84 milligram (mg) [3*1 of spray in each nostril] will be administered intranasally on Day 1 in one of the treatment periods. | Drug | Sequence 1 (ABC), Sequence 2 (BCA), Sequence 3 (CAB), Sequence 4 (CBA), Sequence 5 (ACB), Sequence 6 (BAC) |
| MirtazapineMirtazapine 30 mg capsule will be administered orally on Day 1 in one of the treatment periods. | Drug | Sequence 1 (ABC), Sequence 2 (BCA), Sequence 3 (CAB), Sequence 4 (CBA), Sequence 5 (ACB), Sequence 6 (BAC) |
| Placebo (Matched to Esketamine)Placebo [3*1 in each nostril] will be administered intranasally on Day 1 in one of the treatment periods. | Drug | Sequence 1 (ABC), Sequence 2 (BCA), Sequence 3 (CAB), Sequence 4 (CBA), Sequence 5 (ACB), Sequence 6 (BAC) |
| Placebo (Matched to Mirtazapine)Placebo capsule will be administered orally on Day 1 in one of the treatment periods. | Drug | Sequence 1 (ABC), Sequence 2 (BCA), Sequence 3 (CAB), Sequence 4 (CBA), Sequence 5 (ACB), Sequence 6 (BAC) |
Primary outcome
Standard Deviation of Lateral Position (SDLP) Assessed From an On-road Driving Test
Time frame: 4 to 14 hours post-dose
The SDLP will be measured from a validated on-road driving test in a 100 kilometer (km) highway-driving lane.
9 secondary outcomes
Standard Deviation of Speed (SDS) Assessed From an On-road Driving Test
Time frame: 4 to 14 hours post-dose
Mean Speed (MS) Assessed From an On-road Driving Test
Time frame: 4 to 14 hours post-dose
Mean Lateral Position (MLP) Assessed From an On-road Driving Test
Time frame: 4 to 14 hours post-dose
Subjective Driving Performance Score
Time frame: After completion of driving test (4 to 14 hours post-dose)
Karolinska Sleepiness Scale (KSS) Score
Time frame: Pre-dose, 1, 2 hours and after completion of driving test (4 to 14 hours post-dose)
Columbia Suicide Severity Rating Scale (C-SSRS) Score
Time frame: Up to 7 to 10 days after last dose administration
Brief Psychiatric Rating Scale (BPRS) Symptom Sub-Scale Score
Time frame: Pre-dose, 1 and 2 hours post-dose
Clinician Administered Dissociative States Scale (CADSS) Score
Time frame: Pre-dose, 1 and 2 hours post-dose
Maximum plasma concentration (Cmax)
Time frame: Pre-dose, 0.5, 1, 3 and 4 hours post-dose
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 30 Dec 2014.
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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 Mirtazapine in people with Healthy, 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 30 Dec 2014. 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?
Standard Deviation of Lateral Position (SDLP) Assessed From an On-road Driving Test (time frame: 4 to 14 hours post-dose). 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 30 Dec 2014.