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HealthyPhase 1NCT02094378

A Study to Evaluate the Effect of Intranasal Esketamine on Cognitive Functioning in Healthy Subjects

A Phase 1 study testing Esketamine in people with Healthy, 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 purpose of this study is to assess the cognitive effects associated with administration of intranasal esketamine 84 mg. Read more about this study

Who is it for?
Ages 18 to 49 yearsHealthy 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
24 participants
Where
1 siteNetherlands
Study dates
Jun 2014to Aug 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 to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Body mass index (BMI) (weight [kg]/height[m2]) between 18 and 30 kg/m2 (inclusive), and body weight not less than 45 kg
  • Blood pressure (after the subject is supine for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic at Screening and predose on Day 1 of Period 1
  • A 12-lead ECG consistent with normal cardiac conduction and function at Screening and predose on Day 1 of Period 1
  • Comfortable with self-administration of intranasal medication and able to follow instructions provided
  • Non-smoker for at least 6 months before first study drug administration

Who cannot join

  • Subject has clinically significant liver or renal insufficiency; cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, 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 or on Day 1 of Period 1, as deemed appropriate by the investigator
  • Clinically significant abnormal physical examination, vital signs, or 12-lead 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 (e.g., 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 1 or more of the following symptoms: blockage of 1 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.

Netherlands1 site

  • Study site

    Leiden

Other trials in Netherlands

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, 2-period Crossover Study to Evaluate the Effect of Intranasal Esketamine on Cognitive Functioning in Healthy Subjects

The purpose of this study is to assess the cognitive effects associated with administration of intranasal esketamine 84 mg.

Read the detailed description

This is a randomized (participants assigned to 1 of 2 treatment sequences by chance), double-blind (identity of study drugs will not be known to participant or members of study staff), placebo-controlled (a substance without active drug identical in appearance to esketamine), 2-period crossover study (participants assigned to each treatment sequence will receive 1 dose of esketamine and 1 dose of placebo administered intranasally [through the nose]) conducted in healthy adult participants at a single center. Participants will complete 3 study phases: A screening phase of up to 3 weeks; a 2-week double-blind treatment phase, which includes 2 treatment periods (Periods 1 and 2) separated by a washout interval of at least 7 days; and, a 1-week posttreatment (follow up) phase, if applicable. The duration of the study for each participant will be approximately 6 weeks. Blood and urine samples will be collected during the study for laboratory assessments. Participants will be monitored for safety from the time of signing the informed consent form up until 1 week after the last dose of study drug (or end of treatment).

Conditions
Healthy
Being tested
Esketamine, Placebo
Keywords
Healthy, Esketamine, Cognitive functioning

What participants receive

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

  • EsketamineDrug

    84 mg esketamine administered intranasally

  • PlaceboDrug

    Placebo administered intranasally

Study groups in NCT02094378
Study groupRoleWhat they receive
Esketamine-PlaceboExperimentalParticipants assigned to treatment sequence 1 will receive 84 mg esketamine intranasally on Day 1 of Period 1 and then receive placebo intranasally on Day 1 in Period 2. Periods 1 and 2 will be separated by 7 days.
Receives: Drug: Esketamine; Drug: Placebo
Placebo-EsketaminePlacebo comparatorParticipants assigned to treatment sequence 2 will receive placebo intranasally on Day 1 of Period 1 and then receive 84 mg esketamine intranasally on Day 1 in Period 2. Periods 1 and 2 will be separated by 7 days.
Receives: Drug: Esketamine; Drug: Placebo

What is being measured

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

  1. Change from baseline in cognitive functioning measured by the The Cogstate® Computerized Battery

    The Cogstate® Computerized Battery of tests will include 5 tests: Detection (simple reaction time task measuring processing speed [lower score = better performance]); Identification (choice reaction time paradigm measuring attention [lower score = better performance]); One Card Learning (visual episodic memory measure [higher score = better performance]); One Back ( "n-back" working memory measure [higher score = better performance]); and, Groton Maze Learning Test (executive function measure; total number of errors made in attempting to learn the same hidden pathway on five consecutive trials at a single session [lower score = better performance]) (Maruff 2004, Snyder 2005).

    Measured: On Day 1 at -1 hour, 40 minutes, and at 2, 4, and 6 hours after dosing (or at the end of treatment)

  2. Change from baseline in cognitive functioning measured by the Karolinska Sleepiness Scale (KSS)

    The KSS is a subject-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) (Akerstedt 1990).

    Measured: On day 1 at -1 hour, 40 minutes, and at 2, 4, and 6 hours after dosing (or at the end of treatment)

  3. Change from baseline in cognitive functioning measured by the mental effort scale

    The mental effort scale is a subject-reported assessment of the level of effort needed to complete the test battery on a 15-cm equal interval scale (Zijlstra1993).

    Measured: On Day 1 at -1 hour, 40 minutes, and at 2, 4, and 6 hours after dosing (or at the end of treatment)

Secondary outcomes (3)

  1. The concentration of esketamine and noresketamine from time zero to the last observable concentration (AUClast)

    Measured: Day 1 at 0, 10, and 40 minutes and 1, 2, and 4 hours after dosing

  2. The maximum plasma concentration (Cmax) of esketamine and noresketamine

    Measured: Day 1 at 0,10, and 40 minutes and at 1, 2, 4, and 6 hours after dosing

  3. Time to Maximum Plasma Concentration (Tmax) of esketamine and noresketamine

    Measured: Day 1 at 0, 10, and 40 minutes and 1, 2, 4, and 6 hours after dosing

Timeline

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

  1. First posted21 Mar 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionAug 2014
  4. Study completionAug 2014

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02094378
Sponsor's protocol ID
CR103823
Other IDs
ESKETINTRD1005, 2014-000468-16, 2014
Status last verified
Oct 2014
First submitted
20 Mar 2014
Last updated
16 Oct 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Morrison RL, Fedgchin M, Singh J, Van Gerven J, Zuiker R, Lim KS, van der Ark P, Wajs E, Xi L, Zannikos P, Drevets WC. Effect of intranasal esketamine on cognitive functioning in healthy participants: a randomized, double-blind, placebo-controlled study. Psychopharmacology (Berl). 2018 Apr;235(4):1107-1119. doi: 10.1007/s00213-018-4828-5. Epub 2018 Feb 1.

    PubMed 29392371

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 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 16 Oct 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. 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?

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?

Change from baseline in cognitive functioning measured by the The Cogstate® Computerized Battery (time frame: On Day 1 at -1 hour, 40 minutes, and at 2, 4, and 6 hours after dosing (or at the end of treatment)). The study lists 3 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 NCT02094378, 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 16 Oct 2014.

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