HealthyPhase 1NCT02129088
A Pharmacokinetic, Safety and Tolerability Study of Esketamine in Healthy Elderly and Adult Participants
A Phase 1 study testing Esketamine in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
Trial summary
The purpose of this study is to compare the pharmacokinetics (explores what the body does to the drug), safety and tolerability of esketamine, administered intranasally (administered through the nose) in healthy elderly (Cohort 1) and healthy adult (Cohort 2) participants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Esketamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2014to May 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female participant must be postmenopausal (no spontaneous menses for at least 2 years), surgically sterile, abstinent (abstinence is an acceptable means of birth control only if it is already established as the participant's usual and preferred lifestyle), or, if sexually active, be practicing an effective method of birth control (for example, prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study
- Body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m^2) (inclusive), and body weight not less than 50 kilogram (kg)
- Systolic blood pressure (after the participant is supine for 5 minutes) between 90 and 150 millimeter of mercury (mmHg) (inclusive) and diastolic blood pressure not more than 90 mmHg
- Comfortable with self-administration of intranasal medication and able to follow instructions provided
- A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function
Who cannot join
- Current significant psychiatric (mental disorders) disorder including but not limited to psychotic (a person exhibiting mental illness), bipolar, major depressive or anxiety disorder
- Clinically significant medical illness including (but not limited to) cardiac arrhythmias (irregular heart beat) or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias [disorder of blood]), lipid abnormalities, significant pulmonary (having to do with the lungs) disease, including bronchospastic respiratory disease, diabetes mellitus (disorder in which there is decreased insulin in the body or the body's insulin is not effective, resulting in high blood sugar, increased thirst and urine, and many other side effects), renal or hepatic insufficiency, thyroid disease, neurologic disease, infection, hypertension or vascular disorders, kidney or urinary tract disturbances, sleep apnea (breathing problems while sleeping), myasthenia gravis (disorder that causes muscles to get tired quickly), or any other illness that the Investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Use of any prescription or nonprescription medication, within 14 days before the first scheduled dose of the study drug
- Anatomical or medical conditions that may delay delivery or absorption of study medication (for example. undergone facial reconstructions, structural or functional abnormalities of the nose or upper airway; obstructions or mucosal lesions (any visible local abnormality of the tissues of the skin) of the nostrils or nasal passages; undergone sinus (a depression or cavity formed by a bending or curving) surgery in the previous 2 years; or signs and symptoms of upper respiratory infection, rhinitis, active allergies, or has a history of frequent sinus infections or complications)
- Has an abnormal or deviated nasal septum (when the inner wall separating the two sides of the nose is off to one side) with any 1 or more of the following symptoms: blockage of 1 or both nostrils, nasal congestion (especially 1-sided), frequent nosebleeds, frequent sinus infections, noisy breathing during sleep, facial pain, headaches, and postnasal drip
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Single-Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine in Healthy Elderly and Adult Subjects
The purpose of this study is to compare the pharmacokinetics (explores what the body does to the drug), safety and tolerability of esketamine, administered intranasally (administered through the nose) in healthy elderly (Cohort 1) and healthy adult (Cohort 2) participants.
Read the detailed description
This is a Phase 1, open-label (all people know the identity of the intervention), single-center, and single-dose study of esketamine, in healthy elderly (Cohort 1) and adult (Cohort 2) participants. Cohort 1 will comprise of 14 healthy elderly participants (greater than or equal to [>=] 65 years) with at least 3 participants above >=75 years of age and Cohort 2 will comprise of 20 healthy adult participants (18 to 55 years of age, inclusive). The study comprises of 3 phases: a Screening phase, an open-label Treatment phase (consisting of 1 treatment period for Cohort 1 and 2 treatment periods for Cohort 2), and a Safety follow-up phase. The duration of Screening phase is of 3 weeks; duration of treatment period for cohort 1 is of 3 days and for cohort 2 is 3 - 5 days (In Treatment period 1: 5 days for the first 7 participants who will complete the additional urine and fecal collection up to 72 hours post dose and 3 days for the last 13 participants who will be discharged after 24 hours; in Treatment period 2: 3 days for all participants). A washout period of 5 to 10 days will separate each intranasal esketamine treatment regimen for Cohort 2. All participants in Cohort 1 will receive Treatment A (that is, esketamine 14 milligram [mg] will be self-administered as intranasal spray into each nostril under the direct supervision of the investigator or designee), whereas, all participants in Cohort 2 will receive Treatment A followed by Treatment B (that is, esketamine 14 mg will be self-administered as intranasal spray followed by self-administration of placebo solution after 5 and 10 minutes of esketamine administration into each nostril, under the direct supervision of the investigator or designee) in a fixed sequence. The total esketamine dose will be 28 mg for each regimen. Blood samples will be collected for evaluation of pharmacokinetic parameters pre-dose and until 24 hours post-dose for evaluation of pharmacokinetic parameters. Participants' safety will be monitored throughout the study.
- Conditions
- Healthy
- Being tested
- Esketamine, Placebo
- Keywords
- Healthy, Esketamine, Phase 1, Placebo, Elderly, Adult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
Esketamine 14 mg will be self-administered by participants as intranasal spray into each nostril on Day 1 to cohort 1 and cohort 2 in a fixed sequence.
PlaceboDrug
Placebo will be self-administered as intranasal spray by participants after 5 and 10 minutes of esketamine administration into each nostril on Day 1 of Treatment period 2 to Cohort 2.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants will receive esketamine 14 milligram (mg) as intranasal spray into each nostril on Day 1. Receives: Drug: Esketamine |
| Cohort 2 | Experimental | All participants will receive esketamine 14 mg as intranasal spray into each nostril on Day 1 of Period 1 as Treatment A and esketamine 14 mg as intranasal spray followed by intranasal administration of placebo solution after 5 and 10 minutes of esketamine administration into each nostril on Day 1 of Period 2 as Treatment B in a fixed sequence. Receives: Drug: Esketamine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of Esketamine
The Cmax is the maximum plasma concentration.
Measured: 0 (pre-dose), 7, 12, 22, 32, 40, 50 minutes; 1, 1.25, 1.5, 2, 3, 4, 6, 9, 12, 18 and 24 hours after study drug administration
Time to Reach Maximum Concentration (tmax)
The tmax is time to reach the maximum observed plasma concentration.
Measured: 0 (pre-dose), 7, 12, 22, 32, 40, 50 minutes; 1, 1.25, 1.5, 2, 3, 4, 6, 9, 12, 18 and 24 hours after study drug administration
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
Measured: 0 (pre-dose), 7, 12, 22, 32, 40, 50 minutes; 1, 1.25, 1.5, 2, 3, 4, 6, 9, 12, 18 and 24 hours after study drug administration
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(0-last)/lambda(z), wherein AUC(0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time; C(0-last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
Measured: 0 (pre-dose), 7, 12, 22, 32, 40, 50 minutes; 1, 1.25, 1.5, 2, 3, 4, 6, 9, 12, 18 and 24 hours after study drug administration
Percentage Area Under the Plasma Concentration Curve From Time Zero to Infinite Time (%AUC [0-infinity])
Percentage AUC[0-infinity] is obtained by extrapolation of the concentration-time curve. It is calculated by AUC[0-infinity] minus AUC[0-last] divided by AUC[0-infinity] multiplied by 100.
Measured: 0 (pre-dose), 7, 12, 22, 32, 40, 50 minutes; 1, 1.25, 1.5, 2, 3, 4, 6, 9, 12, 18 and 24 hours after study drug administration
Elimination Half-Life (t [1/2] Lambda)
Elimination half-life (t [1/2] Lambda) is associated with the terminal slope (lambda [z]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).
Measured: 0 (pre-dose), 7, 12, 22, 32, 40, 50 minutes; 1, 1.25, 1.5, 2, 3, 4, 6, 9, 12, 18 and 24 hours after study drug administration
Rate Constant (Lambda[z])
Lambda(z) is first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve .
Measured: 0 (pre-dose), 7, 12, 22, 32, 40, 50 minutes; 1, 1.25, 1.5, 2, 3, 4, 6, 9, 12, 18 and 24 hour after study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2014
- Study completionMay 2014
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 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 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
- NCT02129088
- Sponsor's protocol ID
- CR103806
- Other IDs
- ESKETINTRD1003, 2013-005372-18
- Status last verified
- Jul 2014
- First submitted
- 30 Apr 2014
- Last updated
- 25 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Perez-Ruixo C, Rossenu S, Zannikos P, Nandy P, Singh J, Drevets WC, Perez-Ruixo JJ. Population Pharmacokinetics of Esketamine Nasal Spray and its Metabolite Noresketamine in Healthy Subjects and Patients with Treatment-Resistant Depression. Clin Pharmacokinet. 2021 Apr;60(4):501-516. doi: 10.1007/s40262-020-00953-4. Epub 2020 Oct 31.
PubMed 33128208
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine in Healthy Elderly and Adult Subjects
- ClinicalTrials.gov ID
- NCT02129088
- Acronym / sponsor ID
- CR103806
- Conditions
- Healthy
- Keywords
- Healthy, Esketamine, Phase 1, Placebo, Elderly, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 2 May 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 compare the pharmacokinetics (explores what the body does to the drug), safety and tolerability of esketamine, administered intranasally (administered through the nose) in healthy elderly (Cohort 1) and healthy adult (Cohort 2) participants.
Detailed description
This is a Phase 1, open-label (all people know the identity of the intervention), single-center, and single-dose study of esketamine, in healthy elderly (Cohort 1) and adult (Cohort 2) participants. Cohort 1 will comprise of 14 healthy elderly participants (greater than or equal to [>=] 65 years) with at least 3 participants above >=75 years of age and Cohort 2 will comprise of 20 healthy adult participants (18 to 55 years of age, inclusive). The study comprises of 3 phases: a Screening phase, an open-label Treatment phase (consisting of 1 treatment period for Cohort 1 and 2 treatment periods for Cohort 2), and a Safety follow-up phase. The duration of Screening phase is of 3 weeks; duration of treatment period for cohort 1 is of 3 days and for cohort 2 is 3 - 5 days (In Treatment period 1: 5 days for the first 7 participants who will complete the additional urine and fecal collection up to 72 hours post dose and 3 days for the last 13 participants who will be discharged after 24 hours; in Treatment period 2: 3 days for all participants). A washout period of 5 to 10 days will separate each intranasal esketamine treatment regimen for Cohort 2. All participants in Cohort 1 will receive Treatment A (that is, esketamine 14 milligram [mg] will be self-administered as intranasal spray into each nostril under the direct supervision of the investigator or designee), whereas, all participants in Cohort 2 will receive Treatment A followed by Treatment B (that is, esketamine 14 mg will be self-administered as intranasal spray followed by self-administration of placebo solution after 5 and 10 minutes of esketamine administration into each nostril, under the direct supervision of the investigator or designee) in a fixed sequence. The total esketamine dose will be 28 mg for each regimen. Blood samples will be collected for evaluation of pharmacokinetic parameters pre-dose and until 24 hours post-dose for evaluation of pharmacokinetic parameters. Participants' safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: EsketamineParticipants will receive esketamine 14 milligram (mg) as intranasal spray into each nostril on Day 1. |
| Cohort 2 | Experimental | Drug: Esketamine, Drug: PlaceboAll participants will receive esketamine 14 mg as intranasal spray into each nostril on Day 1 of Period 1 as Treatment A and esketamine 14 mg as intranasal spray followed by intranasal administration of placebo solution after 5 and 10 minutes of esketamine administration into each nostril on Day 1 of Period 2 as Treatment B in a fixed sequence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female participant must be postmenopausal (no spontaneous menses for at least 2 years), surgically sterile, abstinent (abstinence is an acceptable means of birth control only if it is already established as the participant's usual and preferred lifestyle), or, if sexually active, be practicing an effective method of birth control (for example, prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study
- Body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m^2) (inclusive), and body weight not less than 50 kilogram (kg)
- Systolic blood pressure (after the participant is supine for 5 minutes) between 90 and 150 millimeter of mercury (mmHg) (inclusive) and diastolic blood pressure not more than 90 mmHg
- Comfortable with self-administration of intranasal medication and able to follow instructions provided
- A 12-lead electrocardiogram (ECG) consistent with normal cardiac conduction and function
Key exclusion criteria (5 listed)
- Current significant psychiatric (mental disorders) disorder including but not limited to psychotic (a person exhibiting mental illness), bipolar, major depressive or anxiety disorder
- Clinically significant medical illness including (but not limited to) cardiac arrhythmias (irregular heart beat) or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias [disorder of blood]), lipid abnormalities, significant pulmonary (having to do with the lungs) disease, including bronchospastic respiratory disease, diabetes mellitus (disorder in which there is decreased insulin in the body or the body's insulin is not effective, resulting in high blood sugar, increased thirst and urine, and many other side effects), renal or hepatic insufficiency, thyroid disease, neurologic disease, infection, hypertension or vascular disorders, kidney or urinary tract disturbances, sleep apnea (breathing problems while sleeping), myasthenia gravis (disorder that causes muscles to get tired quickly), or any other illness that the Investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Use of any prescription or nonprescription medication, within 14 days before the first scheduled dose of the study drug
- Anatomical or medical conditions that may delay delivery or absorption of study medication (for example. undergone facial reconstructions, structural or functional abnormalities of the nose or upper airway; obstructions or mucosal lesions (any visible local abnormality of the tissues of the skin) of the nostrils or nasal passages; undergone sinus (a depression or cavity formed by a bending or curving) surgery in the previous 2 years; or signs and symptoms of upper respiratory infection, rhinitis, active allergies, or has a history of frequent sinus infections or complications)
- Has an abnormal or deviated nasal septum (when the inner wall separating the two sides of the nose is off to one side) with any 1 or more of the following symptoms: blockage of 1 or both nostrils, nasal congestion (especially 1-sided), frequent nosebleeds, frequent sinus infections, noisy breathing during sleep, 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 |
|---|---|---|
| EsketamineEsketamine 14 mg will be self-administered by participants as intranasal spray into each nostril on Day 1 to cohort 1 and cohort 2 in a fixed sequence. | Drug | Cohort 1, Cohort 2 |
| PlaceboPlacebo will be self-administered as intranasal spray by participants after 5 and 10 minutes of esketamine administration into each nostril on Day 1 of Treatment period 2 to Cohort 2. | Drug | Cohort 2 |
Primary outcome
Maximum Plasma Concentration (Cmax) of Esketamine
Time frame: 0 (pre-dose), 7, 12, 22, 32, 40, 50 minutes; 1, 1.25, 1.5, 2, 3, 4, 6, 9, 12, 18 and 24 hours after study drug administration
The Cmax is the maximum plasma concentration.
Time to Reach Maximum Concentration (tmax)
Time frame: 0 (pre-dose), 7, 12, 22, 32, 40, 50 minutes; 1, 1.25, 1.5, 2, 3, 4, 6, 9, 12, 18 and 24 hours after study drug administration
The tmax is time to reach the maximum observed plasma concentration.
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])
Time frame: 0 (pre-dose), 7, 12, 22, 32, 40, 50 minutes; 1, 1.25, 1.5, 2, 3, 4, 6, 9, 12, 18 and 24 hours after study drug administration
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
Time frame: 0 (pre-dose), 7, 12, 22, 32, 40, 50 minutes; 1, 1.25, 1.5, 2, 3, 4, 6, 9, 12, 18 and 24 hours after study drug administration
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(0-last)/lambda(z), wherein AUC(0-last) is area under the plasma concentration-time curve from time zero to last quantifiable time; C(0-last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant.
Percentage Area Under the Plasma Concentration Curve From Time Zero to Infinite Time (%AUC [0-infinity])
Time frame: 0 (pre-dose), 7, 12, 22, 32, 40, 50 minutes; 1, 1.25, 1.5, 2, 3, 4, 6, 9, 12, 18 and 24 hours after study drug administration
Percentage AUC[0-infinity] is obtained by extrapolation of the concentration-time curve. It is calculated by AUC[0-infinity] minus AUC[0-last] divided by AUC[0-infinity] multiplied by 100.
Elimination Half-Life (t [1/2] Lambda)
Time frame: 0 (pre-dose), 7, 12, 22, 32, 40, 50 minutes; 1, 1.25, 1.5, 2, 3, 4, 6, 9, 12, 18 and 24 hours after study drug administration
Elimination half-life (t [1/2] Lambda) is associated with the terminal slope (lambda [z]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z).
Rate Constant (Lambda[z])
Time frame: 0 (pre-dose), 7, 12, 22, 32, 40, 50 minutes; 1, 1.25, 1.5, 2, 3, 4, 6, 9, 12, 18 and 24 hour after study drug administration
Lambda(z) is first-order rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve .
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 25 Jul 2014.
- Derived from this study: PubMed 33128208Perez-Ruixo C, Rossenu S, Zannikos P, Nandy P, Singh J, Drevets WC, Perez-Ruixo JJ. Population Pharmacokinetics of Esketamine Nasal Spray and its Metabolite Noresketamine in Healthy Subjects and Patients with Treatment-Resistant Depression. Clin Pharmacokinet. 2021 Apr;60(4):501-516. doi: 10.1007/s40262-020-00953-4. Epub 2020 Oct 31.
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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 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
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 25 Jul 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 Belgium. 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?
Maximum Plasma Concentration (Cmax) of Esketamine (time frame: 0 (pre-dose), 7, 12, 22, 32, 40, 50 minutes; 1, 1.25, 1.5, 2, 3, 4, 6, 9, 12, 18 and 24 hours after study drug administration). The study lists 7 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 NCT02129088, 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 25 Jul 2014; AzTrials last refreshed its copy on 8 Nov 2026.