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Pre-Approval Access to Esketamine Nasal Spray for the Treatment of Treatment-Resistant Depression (TRD)

Primary Purpose

Depressive Disorder, Treatment-Resistant

Status
Approved for marketing
Phase
Locations
Study Type
Expanded Access
Intervention
Esketamine
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Depressive Disorder, Treatment-Resistant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Must have an unmet medical need to treat treatment-resistant depression (TRD) with esketamine nasal spray, an investigational compound, that has not been approved by any health authority. This means no other treatment options are available and the participant must be unable to participate in a clinical trial; for example, because they do not fulfill the eligibility criteria of the protocol or there are no trial sites within a reasonable distance of where they reside
  • Must not participate in a clinical trial or be concurrently treated with an investigational drug when being treated with esketamine nasal spray
  • Participants must have TRD with the diagnosis verified by a psychiatrist, and have exhausted all other options including all alternative treatment options with marketed therapies, specifically:

    1. Participant must meet the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnostic criteria for single-episode major depressive episode (major depressive disorder [MDD]) (if single-episode MDD, the duration must be greater than [>]2 years) or recurrent MDD, without psychotic features.
    2. Participant must have had nonresponse to 2 or more oral antidepressant treatments in the current episode of depression confirmed by documented medical history and/or pharmacy/prescription records to meet criteria for TRD and have failed at least one augmentation strategy (for example, atypical antipsychotics such as aripiprazole or quetiapine, lithium, thyroid hormones, bupropion, etc) and have failed an adequate course (greater than or equal to [>=] 7 unilateral [UL] sessions) of, or have a contraindication to electro-convulsive therapy (ECT) and transcranial magnetic stimulation (TMS)
  • Participants must have exhausted clinical trials, early access programs or named patient programs that may be available in their region
  • Participants must have moderate to severe depression per clinical judgment

Exclusion Criteria:

  • The participant's depressive symptoms have previously demonstrated nonresponse to Esketamine Nasal Spray or ketamine in the current major depressive episode per clinical judgment
  • Participant has a current or prior DSM-5 diagnosis of a psychotic disorder or MDD with psychosis, bipolar or related disorders, comorbid obsessive- compulsive disorder, intellectual disability (only DSM-5 diagnostic code 319), borderline personality disorder, antisocial personality disorder, histrionic personality disorder, or narcissistic personality disorder
  • Participant has homicidal ideation/intent or has suicidal ideation with some intent to act within 6 months or a history of suicidal behavior within the past year, per the requesting psychiatrist's clinical judgment
  • Participant has a history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria, except nicotine or caffeine, within 6 months before the start of the first dose.

    a) A history (lifetime) of ketamine, phencyclidine (PCP), lysergic acid diethylamide (LSD), or 3, 4-methylenedioxy-methamphetamine (MDMA) hallucinogen-related use disorder is exclusionary

  • Participants with a current or past history of seizures (uncomplicated childhood febrile seizures with no sequelae are not exclusionary)

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 1, 2019
    Last Updated
    February 6, 2020
    Sponsor
    Janssen Research & Development, LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03829579
    Brief Title
    Pre-Approval Access to Esketamine Nasal Spray for the Treatment of Treatment-Resistant Depression (TRD)
    Official Title
    Esketamine Single Patient Request
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Approved for marketing
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Janssen Research & Development, LLC

    4. Oversight

    5. Study Description

    Brief Summary
    This is a pre-approval access program (PAAP) for eligible participants. The main purpose of this program is to provide access to esketamine nasal spray to eligible participant with treatment-resistant depression (TRD), who have exhausted all other treatment options, including all alternative treatment options with marketed therapies.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depressive Disorder, Treatment-Resistant

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Esketamine
    Intervention Description
    Participants will self-administer esketamine nasal spray, under the supervision of the healthcare professional at the site of care. A starting dose of 56 milligram (mg) will be administered intranasally into each nostril on Day 1 with subsequent doses of 56 mg or 84 mg administered during Weeks 1-4 (2 treatment sessions per week). For participants who respond, treatment is continued as follows: 56 mg or 84 mg of esketamine nasal spray during Weeks 5-8 (once weekly), and Week 9 onwards (every 2 weeks or once weekly), with period re-evaluation to determine the need for continued treatment. Doses will be adjusted based on efficacy and tolerability to the previous dosing.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: Must have an unmet medical need to treat treatment-resistant depression (TRD) with esketamine nasal spray, an investigational compound, that has not been approved by any health authority. This means no other treatment options are available and the participant must be unable to participate in a clinical trial; for example, because they do not fulfill the eligibility criteria of the protocol or there are no trial sites within a reasonable distance of where they reside Must not participate in a clinical trial or be concurrently treated with an investigational drug when being treated with esketamine nasal spray Participants must have TRD with the diagnosis verified by a psychiatrist, and have exhausted all other options including all alternative treatment options with marketed therapies, specifically: Participant must meet the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnostic criteria for single-episode major depressive episode (major depressive disorder [MDD]) (if single-episode MDD, the duration must be greater than [>]2 years) or recurrent MDD, without psychotic features. Participant must have had nonresponse to 2 or more oral antidepressant treatments in the current episode of depression confirmed by documented medical history and/or pharmacy/prescription records to meet criteria for TRD and have failed at least one augmentation strategy (for example, atypical antipsychotics such as aripiprazole or quetiapine, lithium, thyroid hormones, bupropion, etc) and have failed an adequate course (greater than or equal to [>=] 7 unilateral [UL] sessions) of, or have a contraindication to electro-convulsive therapy (ECT) and transcranial magnetic stimulation (TMS) Participants must have exhausted clinical trials, early access programs or named patient programs that may be available in their region Participants must have moderate to severe depression per clinical judgment Exclusion Criteria: The participant's depressive symptoms have previously demonstrated nonresponse to Esketamine Nasal Spray or ketamine in the current major depressive episode per clinical judgment Participant has a current or prior DSM-5 diagnosis of a psychotic disorder or MDD with psychosis, bipolar or related disorders, comorbid obsessive- compulsive disorder, intellectual disability (only DSM-5 diagnostic code 319), borderline personality disorder, antisocial personality disorder, histrionic personality disorder, or narcissistic personality disorder Participant has homicidal ideation/intent or has suicidal ideation with some intent to act within 6 months or a history of suicidal behavior within the past year, per the requesting psychiatrist's clinical judgment Participant has a history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria, except nicotine or caffeine, within 6 months before the start of the first dose. a) A history (lifetime) of ketamine, phencyclidine (PCP), lysergic acid diethylamide (LSD), or 3, 4-methylenedioxy-methamphetamine (MDMA) hallucinogen-related use disorder is exclusionary Participants with a current or past history of seizures (uncomplicated childhood febrile seizures with no sequelae are not exclusionary)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janssen Research & Development, LLC Clinical Trial
    Organizational Affiliation
    Janssen Research & Development, LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Pre-Approval Access to Esketamine Nasal Spray for the Treatment of Treatment-Resistant Depression (TRD)

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