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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 (DriveSaFe2)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2016 by Janssen Research & Development, LLC
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT02919579
First received: September 1, 2016
Last updated: September 28, 2016
Last verified: September 2016
  Purpose
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 deviation of lateral position (SDLP) from an on-road driving test.

Condition Intervention Phase
Depressive Disorder, Major
Drug: Placebo (Intranasal)
Drug: Esketamine
Other: Alcohol
Drug: Placebo (Oral)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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)

Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Driving performance will be assessed by the mean difference of standard deviation of lateral position (SDLP) from an on-road driving test.


Secondary Outcome Measures:
  • Effect on Subjective Driving Ability Scale [ Time Frame: Part A: Day 2; Part B: Day 1, 11, 18 and 25 ] [ Designated as safety issue: No ]
    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'.

  • Karolinska Sleepiness Scale (KSS) Score [ Time Frame: Part A: Day 2; Part B: Day 1, 11, 18 and 25 ] [ Designated as safety issue: No ]
    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).

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: Yes ]
    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").

  • 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) ] [ Designated as safety issue: No ]
    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.

  • Effect on Subjective Mental Effort Scale [ Time Frame: Part A: Day 2; Part B: Day 1, 11, 18 and 25 ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 24
Study Start Date: September 2016
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part A: Sequence ABC (Placebo+Alcohol+Esketamine)
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.
Drug: 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: Esketamine
Participants will receive intranasal esketamine in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.
Other: Alcohol
Participants will receive oral alcohol in Part A (as per the treatment sequence in period 1,2 and 3).
Drug: Placebo (Oral)
Participants will receive oral placebo in Part A (as per the treatment sequence in period 1,2 and 3).
Experimental: Part A: Sequence BCA (Placebo+Alcohol+Esketamine)
Participants will receive Treatment B in Period 1, then Treatment C in Period 2, followed by Treatment A in Period 3.
Drug: 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: Esketamine
Participants will receive intranasal esketamine in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.
Other: Alcohol
Participants will receive oral alcohol in Part A (as per the treatment sequence in period 1,2 and 3).
Drug: Placebo (Oral)
Participants will receive oral placebo in Part A (as per the treatment sequence in period 1,2 and 3).
Experimental: Part A: Sequence CAB (Placebo+Alcohol+Esketamine)
Participants will receive Treatment C in Period 1, then Treatment A in Period 2, followed by Treatment B in Period 3.
Drug: 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: Esketamine
Participants will receive intranasal esketamine in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.
Other: Alcohol
Participants will receive oral alcohol in Part A (as per the treatment sequence in period 1,2 and 3).
Drug: Placebo (Oral)
Participants will receive oral placebo in Part A (as per the treatment sequence in period 1,2 and 3).
Experimental: Part A: Sequence CBA (Placebo+Alcohol+Esketamine)
Participants will receive Treatment C in Period 1, then Treatment B in Period 2, followed by Treatment A in Period 3.
Drug: 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: Esketamine
Participants will receive intranasal esketamine in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.
Other: Alcohol
Participants will receive oral alcohol in Part A (as per the treatment sequence in period 1,2 and 3).
Drug: Placebo (Oral)
Participants will receive oral placebo in Part A (as per the treatment sequence in period 1,2 and 3).
Experimental: Part A: Sequence ACB (Placebo+Alcohol+Esketamine)
Participants will receive Treatment A in Period 1, then Treatment C in Period 2, followed by Treatment B in Period 3.
Drug: 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: Esketamine
Participants will receive intranasal esketamine in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.
Other: Alcohol
Participants will receive oral alcohol in Part A (as per the treatment sequence in period 1,2 and 3).
Drug: Placebo (Oral)
Participants will receive oral placebo in Part A (as per the treatment sequence in period 1,2 and 3).
Experimental: Part A: Sequence BAC (Placebo+Alcohol+Esketamine)
Participants will receive Treatment B in Period 1, then Treatment A in Period 2, followed by Treatment C in Period 3.
Drug: 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: Esketamine
Participants will receive intranasal esketamine in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.
Other: Alcohol
Participants will receive oral alcohol in Part A (as per the treatment sequence in period 1,2 and 3).
Drug: Placebo (Oral)
Participants will receive oral placebo in Part A (as per the treatment sequence in period 1,2 and 3).
Experimental: Part B: Placebo+Esketamine
Participants will receive intranasal placebo on Day 1, followed by intranasal esketamine on Days 4, 8, 11, 15, 18, 22 and 25.
Drug: 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: Esketamine
Participants will receive intranasal esketamine in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.

  Eligibility

Ages Eligible for Study:   22 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02919579

Contacts
Contact: This study is not yet recruiting patients. Please check back for future recruiting sites, or email JNJ.CT@sylogent.com

Locations
Netherlands
Not yet recruiting
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: NCT02919579     History of Changes
Other Study ID Numbers: CR108228  2016-002424-86  54135419TRD1019 
Study First Received: September 1, 2016
Last Updated: September 28, 2016
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2016