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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03829579
Expanded Access Status : Approved for marketing
First Posted : February 4, 2019
Last Update Posted : February 10, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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.

Condition or disease Intervention/treatment
Depressive Disorder, Treatment-Resistant Drug: Esketamine

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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Esketamine Single Patient Request

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: Esketamine
    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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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:

    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)

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): NCT03829579


Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT03829579    
Other Study ID Numbers: CR108572
54135419TRD3012 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 10, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Treatment-Resistant
Mood Disorders
Mental Disorders
Esketamine
Antidepressive Agents
Psychotropic Drugs