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

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ClinicalTrials.gov Identifier: NCT02094378
Recruitment Status : Completed
First Posted : March 21, 2014
Last Update Posted : October 16, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to assess the cognitive effects associated with administration of intranasal esketamine 84 mg.

Condition or disease Intervention/treatment Phase
Healthy Drug: Esketamine Drug: Placebo Phase 1

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).

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : June 2014
Primary Completion Date : August 2014
Study Completion Date : August 2014
Arms and Interventions

Arm Intervention/treatment
Experimental: Esketamine-Placebo
Participants 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.
Drug: Esketamine
84 mg esketamine administered intranasally
Drug: Placebo
Placebo administered intranasally
Placebo Comparator: Placebo-Esketamine
Participants 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.
Drug: Esketamine
84 mg esketamine administered intranasally
Drug: Placebo
Placebo administered intranasally


Outcome Measures

Primary Outcome Measures :
  1. 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 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).

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

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


Secondary Outcome Measures :
  1. The concentration of esketamine and noresketamine from time zero to the last observable concentration (AUClast) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Day 1 at 0, 10, and 40 minutes and 1, 2, 4, and 6 hours after dosing ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02094378


Locations
Netherlands
Leiden, Netherlands
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02094378     History of Changes
Other Study ID Numbers: CR103823
ESKETINTRD1005 ( Other Identifier: Janssen Research & Development, LLC )
2014-000468-16 ( EudraCT Number )
First Posted: March 21, 2014    Key Record Dates
Last Update Posted: October 16, 2014
Last Verified: October 2014

Keywords provided by Janssen Research & Development, LLC:
Healthy
Esketamine
Cognitive functioning