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NMDA receptor antagonist

Esketamine Nasal Spray for Depression (SUSTAIN-3 Trial)

Phase 3
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ind phase: up to 4 weeks; op/ma phase: up to 78 months
Awards & highlights

SUSTAIN-3 Trial Summary

This trial will test if esketamine is a safe and tolerable treatment for people with treatment-resistant depression.

Eligible Conditions
  • Depression

SUSTAIN-3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~ind phase: up to 4 weeks; op/ma phase: up to 78 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and ind phase: up to 4 weeks; op/ma phase: up to 78 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Blood Oxygen Saturation
Change From Baseline in Heart Rate
Change From Baseline in Respiratory Rate
+9 more
Secondary outcome measures
Change From Baseline as Assessed by EQ 5D-5L: Sum Score
Change From Baseline in Clinical Global Impression-severity (CGI-S) Score
Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score
+4 more

Side effects data

From 2022 Phase 3 trial • 1148 Patients • NCT02782104
22%
Dissociation
21%
Dizziness
18%
Nausea
17%
Vertigo
17%
Dysgeusia
15%
Headache
10%
Hypoaesthesia
9%
Somnolence
8%
Vision Blurred
8%
Hypoaesthesia Oral
8%
Blood Pressure Increased
7%
Anxiety
6%
Throat Irritation
6%
Paraesthesia Oral
5%
Feeling Drunk
5%
Nasal Discomfort
5%
Sedation
5%
Dizziness Postural
5%
Paraesthesia
4%
Fatigue
4%
Vomiting
3%
Diplopia
3%
Diarrhoea
3%
Nasopharyngitis
3%
Insomnia
2%
Rhinorrhoea
2%
Oropharyngeal Pain
2%
Urinary Tract Infection
2%
Arthralgia
1%
Back Pain
1%
Abdominal Pain Upper
1%
Cough
1%
Abdominal Pain
1%
Constipation
1%
Influenza
1%
Upper Respiratory Tract Infection
1%
Myalgia
1%
Migraine
100%
80%
60%
40%
20%
0%
Study treatment Arm
Esketamine Nasal Spray (IND Phase)
Esketamine Nasal Spray (OP/MA Phase)

SUSTAIN-3 Trial Design

1Treatment groups
Experimental Treatment
Group I: Esketamine Nasal SprayExperimental Treatment1 Intervention
Open-Label Induction Phase: Participants will self-administer with esketamine nasal spray twice per week for 4 weeks as a flexible dose regimen (56 milligram [mg] or 84 mg for those < 65 years; 28 mg, 56 mg or 84 mg for those >= 65 years). Participants >= 65 years old will start at a dose of 28 mg on Day 1. Optimization/Maintenance Phase: Participants entering from studies ESKETINTRD3001 (NCT02417064), ESKETINTRD3002 (NCT02418585), ESKETINTRD3003 (NCT02493868), ESKETINTRD3004 (NCT02497287), or ESKETINTRD3006 (US sites only) will self-administer esketamine nasal spray (same dose) once weekly. Participants entering from study ESKETINTRD3005 (NCT02422186) will self-administer esketamine nasal spray (28 mg in week 1; 28 or 56 mg in week 2; and 28, 56 or 84 mg in week 3 and 4) once weekly. After Week 4 (starting at Week 5), based on the Investigator's clinical judgment, the dose of esketamine for all participants can be adjusted based upon efficacy and tolerability.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Esketamine Nasal Spray
2016
Completed Phase 3
~1150

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,383,160 Total Patients Enrolled
44 Trials studying Depression
10,635 Patients Enrolled for Depression
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,958,757 Total Patients Enrolled
36 Trials studying Depression
9,164 Patients Enrolled for Depression

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the researchers trying to achieve with this experiment?

"Janssen Research & Development, LLC, the primary sponsor for this clinical trial, has announced that the primary outcome being measured over the course of the study is change in heart rate from baseline. This 5 year 3 month long study will also be evaluating secondary outcomes including changes in participant-reported health status, as assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) Visual Analog Scale (VAS), Clinical Global Impression-Severity (CGI-S) score and Participant-Reported Depressive Symptoms Using the Patient Health Questionnaire - 9 (PHQ9) Total Score"

Answered by AI

Are the methods used in this trial new or innovative?

"As of right now, there are 26 Esketamine Nasal Spray clinical trials happening in 95 cities and 31 countries. The first one started back in 2016 and was completed in the Phase 3 drug approval stage. Since then, 48 more studies have been conducted."

Answered by AI

How many subjects are in this experiment?

"Currently, this trial is not recruiting patients. The study was originally posted on June 9th 2016 and the most recent update was October 12th 2022. However, there are other clinical trials that may be of interest; 1357 studies for patients with depressive disorder and 26 for those specifically interested in Esketamine Nasal Spray."

Answered by AI

Has Esketamine Nasal Spray received regulatory approval from the FDA?

"Esketamine Nasal Spray is considered safe by our team at Power. This is due to the fact that it is a Phase 3 trial, meaning that there is evidence of its efficacy and multiple rounds of data supporting its safety."

Answered by AI

In how many different medical clinics is this research being conducted today?

"There are 55 sites running this trial currently, with Boston, Wichita Falls and Ottawa among the locations. To reduce travel requirements, patients should try to enroll at the location nearest them."

Answered by AI

Can you share what indications Esketamine Nasal Spray is most often prescribed for?

"Esketamine Nasal Spray is most frequently used to treat unipolar depression, but it has also been shown to help manage pain, status asthmaticus, and muscle relaxation."

Answered by AI

Could you walk me through other scientific research that has been done on Esketamine Nasal Spray?

"Esketamine Nasal Spray was first studied in 2016 under the identifier NCT02782104. As of now, there have been 48 completed trials with 26 more presently active and recruiting patients. Most of these latter clinical studies are based out of Boston, Massachusetts."

Answered by AI

Are we still recruiting people for this research project?

"This clinical trial is no longer actively recruiting patients, according to the information on clinicaltrials.gov. The study was first posted on June 9, 2016 and was last updated on October 12, 2022. However, there are 1383 other trials currently looking for participants that you may be eligible for."

Answered by AI

Who else is applying?

What state do they live in?
Ontario
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
NCT02782104
~130 spots leftby Apr 2025