An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives

NCT04476446 | Completed Phase 3

• 2 other identifiers: CR10869054135419TRD4006
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this expanded access program (EAP) is to provide expanded access to esketamine treatment and collect additional safety data and quality of life until esketamine is commercially available for participants with Treatment-Resistant Depression (TRD).

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events (AEs)

  An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

  Up to 6 months

Secondary Outcomes (1)

• Change from Baseline in European Quality of Life (EuroQol) Group, 5-Dimension, 5-Level (EQ 5D-5L)

  Up to 6 months

Study Arms (1)

Intranasal Esketamine

EXPERIMENTAL

Induction Phase: Participants will self-administer esketamine intranasally 56 milligram (mg) on Day 1 followed by 56 mg or 84 mg (as a flexible dose regimen) twice per week for 4 weeks. Participants greater than or equal to (\>=) 65 years old will start at a dose of 28 mg on Day 1. Maintenance Phase: Participants will self-administer esketamine 56 mg or 84 mg intranasally once per week from Week 5 to Week 9. Subsequently from Week 9, based on the investigator's clinical judgment, participants will self-administer esketamine 56 mg or 84 mg intranasally once or twice a week.

Drug: Esketamine

Interventions

Esketamine DRUG

Participants will receive esketamine at doses of either 56 mg or 84 mg intranasally once or twice a week based on the investigator's clinical judgment.

Also known as: JNJ-54135419

Intranasal Esketamine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must have an unmet medical need to treat treatment-resistant depression (TRD) with Esketamine Nasal Spray, an investigational compound, that has not been approved the local 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
• Participant 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 (a) Participants must meet the Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM)-5 diagnostic criteria for single-episode major depressive episode (MDD) (if single-episode MDD, the duration must be 2 years) or recurrent MDD, without psychotic features (b) Participants must have had nonresponse to 2 or more oral antidepressant (of the same or a different class) treatments in the current episode of depression confirmed by documented medical history and/or pharmacy/prescription records i.e., treatments were prescribed in adequate dosages for adequate duration with affirmation of treatment adherence, to meet criteria for TRD, and have failed at least one augmentation/combination strategy and have failed an adequate course (greater than or equal to \[\>=\] 7 sessions) of, or have a contraindication/no access or refuses electro-convulsive therapy (ECT)
• Participants must have exhausted clinical trials, early access programs or named patient programs that may be available in your region
• Participants must have moderate to severe depression per clinical judgement
• Participants must be medically stable based on physical examination, medical history, vital signs (including stable blood pressure) and 12-lead electrocardiogram (ECG) performed prior to dosing
• Participants must be medically stable based on clinical laboratory tests (complete blood count (CBC), chemistry, liver enzymes and thyroid stimulating hormone \[TSH\]) performed prior to first dose
• Participants must be comfortable with self-administration of intranasal medication and be able to follow the intranasal administration instructions provided
• Before the start of dosing, a woman must be either: non-childbirth potential or practicing a highly effective method of birth control consistent with local regulations. Men must agree to use a barrier method of birth control.
• A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \[beta-hCG\]) before dosing begins and a negative urine pregnancy test each time tested
• Participants must be willing and able to adhere to the prohibitions and restrictions specified for study
• Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for early access program (EPA) and is willing to participate in the EPA, if required by law or regulation

You may not qualify if:

• 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 Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnosis of a psychotic disorder or major depressive episode (MDD) with psychosis, bipolar or related disorders, or intellectual disability (only DSM-5 diagnostic code 319).
• Participant has homicidal ideation/intent or has suicidal ideation with some intent to act within 6 months per the requesting psychiatrist's clinical judgment

Sponsors & Collaborators

• Janssen-Cilag, S.A.: lead

Study Sites (8)

Clínica de Ansiedad, Depresión y Estrés CADE, S. de R.L. de C.V.

Guadalajara, 44520, Mexico

Location

Gabipros SC.

Mexico City, 07000, Mexico

Location

Avalon Vinculación Médica En Salud Mental

Mexico City, 11000, Mexico

Location

Hospital Espanol

Mexico City, 11520, Mexico

Location

Ketamine Mexico S. de RL. de C.V.

Mexico City, 4100, Mexico

Location

Ángel Alberto Ruiz Chow

México, 01000, Mexico

Location

Especialidades en Neuropsiquiatría de México S.C.

México, 11000, Mexico

Location

Clínica de Interdisciplinas Congnitivo Conductuales

México, 11950, Mexico

Location

MeSH Terms

Conditions

Depression

Interventions

Esketamine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Janssen-Cilag, S.A. Clinical Trial

  Janssen-Cilag, S.A.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 20, 2020
• Study Start: September 8, 2020
• Primary Completion: June 16, 2023
• Study Completion: June 16, 2023
• Last Updated: September 14, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share

Locations

ME (8)