DepressionPhase 3NCT04476446
An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
A Phase 3 study testing Esketamine in people with Depression, run by Janssen-Cilag, S.A. at 8 sites in Mexico.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression
- What is being tested?
- Esketamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 8 sitesMexico
- Study dates
- 8 Sep 2020to 16 Jun 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
- 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 active seizures (uncomplicated childhood febrile seizures with no sequelae are not exclusionary). Participants with a history of seizure are allowed provided that seizures are controlled, and no seizure has been experienced in the 6 months prior to expanded access protocol (EAP) entry
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Mexico8 sites
Clínica de Ansiedad, Depresión y Estrés CADE, S. de R.L. de C.V.
Guadalajara, 44520
Ángel Alberto Ruiz Chow
México, 01000
Especialidades en Neuropsiquiatría de México S.C.
México, 11000
Clínica de Interdisciplinas Congnitivo Conductuales
México, 11950
Gabipros SC.
Mexico City, 07000
Avalon Vinculación Médica En Salud Mental
Mexico City, 11000
Hospital Espanol
Mexico City, 11520
Ketamine Mexico S. de RL. de C.V.
Mexico City, 4100
About this study
Official title: An Open-Label Expanded Access Protocol for Esketamine Treatment of Subjects With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
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
- Being tested
- Esketamine
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
Also called JNJ-54135419
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Esketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months
Secondary outcomes (1)
Change from Baseline in European Quality of Life (EuroQol) Group, 5-Dimension, 5-Level (EQ 5D-5L)
The EQ-5D-5L is a standardized instrument used as a measure of health outcome, designed for self-completion by respondents. The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each of the 5 dimensions is divided into 5 levels of perceived problems. Where Level 1: no problem, Level 2: slight problems, Level 3: moderate problems, Level 4: severe problems and Level 5: extreme problems).
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start8 Sep 2020
- Primary completion16 Jun 2023
- Study completion16 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag, S.A. Clinical Trial, Study director, Janssen-Cilag, S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04476446
- Sponsor's protocol ID
- CR108690
- Other IDs
- 54135419TRD4006
- Status last verified
- Sep 2023
- First submitted
- 15 Jul 2020
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Expanded Access Protocol for Esketamine Treatment of Subjects With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives
- ClinicalTrials.gov ID
- NCT04476446
- Acronym / sponsor ID
- CR108690
- Conditions
- Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Janssen-Cilag, S.A.Industry (pharma, biotech, devices)
- Study start
- 8 Sep 2020 (actual)
- Primary completion
- 16 Jun 2023 (actual)
- Study completion
- 16 Jun 2023 (actual)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intranasal Esketamine | Experimental | Drug: EsketamineInduction 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (5 listed)
- 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
- 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 active seizures (uncomplicated childhood febrile seizures with no sequelae are not exclusionary). Participants with a history of seizure are allowed provided that seizures are controlled, and no seizure has been experienced in the 6 months prior to expanded access protocol (EAP) entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsketamineAlso: JNJ-54135419Participants 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. | Drug | Intranasal Esketamine |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: Up to 6 months
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.
1 secondary outcome
Change from Baseline in European Quality of Life (EuroQol) Group, 5-Dimension, 5-Level (EQ 5D-5L)
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag, S.A. Clinical Trial study director
Janssen-Cilag, S.A.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Esketamine in people with Depression, run by Janssen-Cilag, S.A. at 8 sites in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (AEs) (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2023.