Spravato

Status Asthmaticus, Chronic Pain, Depression + 3 more

Treatment

9 FDA approvals

20 Active Studies for Spravato

What is Spravato

Esketamine

The Generic name of this drug

Treatment Summary

Major depressive disorder (MDD) is a common health condition that can lead to disability or even suicide. In 2019, the FDA approved a new nasal spray drug called Spravato (also known as Esketamine) to help people with MDD who have not responded to other treatments. This is the first time Esketamine has been approved by the FDA. Esketamine is a form of Ketamine, which was approved by the FDA in 1970. It is believed that Esketamine may be an effective treatment for MDD due to its easy administration and fast onset of action, compared to other antidepressant medications which may take weeks to

Spravato

is the brand name

image of different drug pills on a surface

Spravato Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Spravato

Esketamine

2019

1

Approved as Treatment by the FDA

Esketamine, also called Spravato, is approved by the FDA for 9 uses including Pain and Intubation .

Pain

Intubation

Major depressive disorder, recurrent episode

Used to treat Major depressive disorder, recurrent episode in combination with null

Status Asthmaticus

Muscle Relaxation

Chronic Pain

General Anesthesia

Depression

Used in combination with Fluoxetine for Major Depressive Disorder (MDD)

Unipolar Depression

Used to treat Major depressive disorder, recurrent episode in combination with null

Effectiveness

How Spravato Affects Patients

Esketamine is a drug that can cause drowsiness, dizziness, and tiredness. It also has a calming and antidepressant effect. Short-term use of esketamine may lead to trouble concentrating and slower reactions. It has been studied to evaluate its effect on driving ability, and no major difference between those taking esketamine and those taking a placebo was found. Esketamine can increase heart rate, but it is not known to cause long-term heart rhythm issues. Also, it may increase blood pressure, but this effect goes away after about 4 hours. In studies, people taking esketamine had

How Spravato works in the body

Esketamine works by blocking the NMDA receptor, which is a type of glutamate receptor. This helps decrease nerve firing and can be used to treat depression. It is not yet known exactly how esketamine works, but its main metabolite has a similar effect, though with a weaker affinity.

When to interrupt dosage

The suggested dosage of Spravato is contingent upon the recognized ailment, including General Anesthesia, Status Asthmaticus and Muscle Relaxation. The measure of dosage changes as per the technique of administration (e.g. Solution - Nasal or Solution) tabulated in the table beneath.

Condition

Dosage

Administration

Status Asthmaticus

280.0 mg/mL, , 28.0 mg, 28.0 mg/pump actuation

Solution - Nasal, Solution, Nasal,

Chronic Pain

280.0 mg/mL, , 28.0 mg, 28.0 mg/pump actuation

Solution - Nasal, Solution, Nasal,

Depression

280.0 mg/mL, , 28.0 mg, 28.0 mg/pump actuation

Solution - Nasal, Solution, Nasal,

General Anesthesia

280.0 mg/mL, , 28.0 mg, 28.0 mg/pump actuation

Solution - Nasal, Solution, Nasal,

Muscle Relaxation

280.0 mg/mL, , 28.0 mg, 28.0 mg/pump actuation

Solution - Nasal, Solution, Nasal,

Unipolar Depression

280.0 mg/mL, , 28.0 mg, 28.0 mg/pump actuation

Solution - Nasal, Solution, Nasal,

Warnings

Spravato Contraindications

Condition

Risk Level

Notes

Aneurysm

Do Not Combine

Stroke

Do Not Combine

Arteriovenous Malformations

Do Not Combine

Severe Hypersensitivity Reactions

Do Not Combine

Esketamine may interact with Pulse Frequency

There are 20 known major drug interactions with Spravato.

Common Spravato Drug Interactions

Drug Name

Risk Level

Description

Abemaciclib

Major

The metabolism of Abemaciclib can be increased when combined with Esketamine.

Acalabrutinib

Major

The metabolism of Acalabrutinib can be increased when combined with Esketamine.

Alectinib

Major

The metabolism of Alectinib can be increased when combined with Esketamine.

Aminophylline

Major

The metabolism of Aminophylline can be increased when combined with Esketamine.

Astemizole

Major

The metabolism of Astemizole can be increased when combined with Esketamine.

Spravato Toxicity & Overdose Risk

The toxic dose of ketamine hydrochloride for rats is 447mg/kg. People who take ketamine may experience side effects such as nausea, kidney issues, heart problems, and nerve damage. Prolonged use has been linked to physical dependence and withdrawal symptoms, such as cravings, fatigue, poor appetite, and anxiety. It is also known to cause tolerance, meaning increasingly larger doses are needed to experience the same effects. Pregnant women should avoid taking ketamine as it could harm the fetus, and breastfeeding mothers should also avoid it due to the risk of neurotoxicity to the infant.

image of a doctor in a lab doing drug, clinical research

Spravato Novel Uses: Which Conditions Have a Clinical Trial Featuring Spravato?

228 active clinical trials are currently assessing the efficacy of Spravato in relieving Status Asthmaticus, Intubations and facilitating General Anesthesia.

Condition

Clinical Trials

Trial Phases

Depression

212 Actively Recruiting

Phase 3, Phase 2, Not Applicable, Phase 4, Phase 1, Early Phase 1

Status Asthmaticus

1 Actively Recruiting

Phase 2

Chronic Pain

129 Actively Recruiting

Not Applicable, Phase 4, Phase 2, Phase 3, Early Phase 1, Phase 1

Muscle Relaxation

0 Actively Recruiting

General Anesthesia

1 Actively Recruiting

Phase 4

Unipolar Depression

47 Actively Recruiting

Not Applicable, Phase 4, Early Phase 1, Phase 3, Phase 2, Phase 1

Spravato Reviews: What are patients saying about Spravato?

5

Patient Review

3/11/2022

Spravato for Additional Medications to Treat Depression

Sprovato has been a life-changing medication for me. I've gone from being severely suicidal and self-harming to truly happy. It's helped me be a better mom and wife. My psychiatrist says this is the happiest he's seen me in five years, even though there are some side effects like disassociation.

5

Patient Review

7/27/2020

Spravato for Additional Medications to Treat Depression

Spravato was the first and only treatment that helped me achieve remission from my depression. I had been struggling with it for over three decades, and neither medication nor therapy were able to give me any relief. Spravato has truly been a life-saver.

5

Patient Review

4/30/2021

Spravato for Additional Medications to Treat Depression

I had been struggling with depression for 25 years when I finally found a nurse practitioner who uses Spravato in their clinic. This drug completely changed my life for the better and helped me become the person I used to be before depression took over.

5

Patient Review

8/3/2020

Spravato for Additional Medications to Treat Depression

This medication has been a game-changer for me. I'm finally able to live my life without PPHN constantly looming over me.

4.7

Patient Review

6/5/2021

Spravato for Additional Medications to Treat Depression

This treatment completely changed my life for the better after years of depression. I finally feel like I have a reason to live again.

4

Patient Review

10/1/2022

Spravato for Additional Medications to Treat Depression

Finally, after 30 years, something has made a dent in my severe depression. It's not a panacea by any means, but it has lifted the horrible gray fog of numbness. The only downside is that it must be administered by a doctor and you have to stay for two hours afterwards, during which time you cannot drive.

3.3

Patient Review

3/22/2022

Spravato for Additional Medications to Treat Depression

Ketamine infusions were a godsend for my major depressive disorder, but they became too expensive to keep up with because insurance wouldn't cover them. I decided to give esketamine a try since it was covered by my insurance, but I don't think it works nearly as well as the ketamine infusions did. It's also very time-consuming, with 8 treatments in month 1, 4 in month 2, and 2 in month 3.

3

Patient Review

9/24/2019

Spravato for Additional Medications to Treat Depression

This drug is stronger than Ketamine, but the main downside is that it can run down your throat. I found that 28mg didn't do much more than make me relaxed. The second dose started things rolling and after a few minutes I really started to feel it. The third dose is where the fun begins! For the most part, I had a good experience with this drug, especially when coming off of it.

2.7

Patient Review

8/8/2022

Spravato for Additional Medications to Treat Depression

I experienced the typical side effects while taking this medication. I took it for a year, and while it may have helped me initially, I didn't see much improvement over the course of 12 months. I suffer from TRD and anxiety with panic attacks, and it seems like none of the medications work for me.

1.7

Patient Review

8/8/2022

Spravato for Additional Medications to Treat Depression

The location of this treatment is very inconvenient, and I have not seen any benefits after 8 sessions. I'm ready to quit the trial because it feels like a waste of time and resources.

1

Patient Review

5/18/2019

Spravato for Additional Medications to Treat Depression

I had the exact same issue as the first person who posted here. I was approved for the drug, but my provider never got back to me after the initial appointment. Janssen says we should be ready to go, but I've tried contacting my provider multiple times and have gotten no response. Something is definitely wrong here, and it's frustrating that the providers aren't willing to share what that is.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about spravato

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

Is Spravato a psychedelic?

"Industry experts say that of all the psychedelic treatments, Compass Pathways Plc is the furthest along."

Answered by AI

Is Spravato a narcotic?

"Will Spravato be a controlled substance in the United States?

Yes, Spravato (esketamine) is classified as a Schedule III controlled substance in the United States. Spravato is a rapid-acting nasal spray used in combination with an oral antidepressant to treat adults with treatment-resistant depression."

Answered by AI

What is Spravato used for?

"The U.S. Food and Drug Administration today approved Spravato (esketamine) nasal spray to be used in conjunction with an oral antidepressant for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression)."

Answered by AI

How do you qualify for Spravato?

"SPRAVATO® must only be dispensed and administered in certified healthcare settings. Patients being treated in outpatient settings (e.g. medical offices and clinics) must be enrolled in the program."

Answered by AI

How does Spravato make you feel?

"Spravato can cause you to feel sleepy, anxious, or disconnected from yourself and your thoughts. In studies, feeling disconnected from yourself was the most common side effect, and feeling sleepy was one of the most common side effects."

Answered by AI

Clinical Trials for Spravato

Image of AltaSciences, Inc in Cypress, United States.

SBS-147 Safety Study

18 - 55
All Sexes
Cypress, CA

This study is part of the HEAL Initiative supported by the NIH. The purpose of this study is to learn how safe the study drug, SBS-147, is and how people's bodies respond to and process it. Researchers will also look for any side effects that may occur when taking SBS-147. Some participants will receive SBS-147, and others will receive a placebo, which looks the same but does not contain any medicine. This helps researchers fairly compare results. The study includes two parts: Single-Dose Group, where Participants receive SBS-147 or placebo one time. Multiple-Dose Group, where Participants receive SBS-147 or placebo once or twice daily for 7 days.

Phase 1
Waitlist Available

AltaSciences, Inc

Jeff Reich, MD

Sparian Biosciences, Inc

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We made a collection of clinical trials featuring Spravato, we think they might fit your search criteria.
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We made a collection of clinical trials featuring Spravato, we think they might fit your search criteria.
Go to Trials
Image of UCLA Semel Institute in Los Angeles, United States.

Psilocybin-assisted CBT for Depression

21 - 60
All Sexes
Los Angeles, CA

The primary objectives of this clinical investigation are to (1) determine the acceptability and feasibility of joining psilocybin-assisted therapy with cognitive-behavioral therapy (PA-CBT) for patients with depression, (2) optimize CBT to most effectively integrate the psilocybin experience with psychotherapy and (3) examine the clinical benefit of psilocybin as an adjunct to cognitive-behavioral therapy (CBT) for major depressive disorder. This study is a randomized, two-arm, fixed dose trial that will test the feasibility, acceptability, and participant and therapist adherence to PA-CBT. Both treatment arms will receive two doses of psilocybin (10mg and then 25mg, separated by one month). In Phase II, participants will be randomized (1:1) to either a 12-session PA-CBT or a 6-session standard psilocybin-assisted therapy (PAT) condition (3 hours of preparation plus 3 hours of supportive therapy integration following the psilocybin experiences).

Phase 1 & 2
Recruiting

UCLA Semel Institute

Image of University of Rochester Medical Center in Rochester, United States.

Deaf CBT-TS for Suicide Risk

18+
All Sexes
Rochester, NY

The goal of this clinical trial is to learn if a short, Zoom-based intervention, Cognitive Behavioral Therapy for Treatment-Seeking for Deaf Individuals (Deaf CBT-TS) can change beliefs about mental health treatment and increase treatment-seeking behaviors in Deaf adults with untreated mental health or alcohol use problems. It will also see if Deaf CBT-TS may reduce suicide risk and explore factors that may increase the effectiveness of Deaf CBT-TS. The main questions it aims to answer are: * Does Deaf CBT-TS increase positive beliefs about treatment and increase treatment-seeking behaviors? * Does Deaf CBT-TS increase hope and reduce mental health symptoms, suicide ideation, and alcohol use? * Is Deaf CBT-TS more effective for individuals with less cultural stress compared to those with high levels of cultural stress? * Is Deaf CBT-TS more effective for Deaf individuals in residential areas with more Deaf resources than those with less Deaf resources? Researchers will compare individuals who complete Deaf CBT-TS to those on a waitlist to see if Deaf CBT-TS works to increase positive beliefs about treatment and treatment-seeking behaviors. Participants will: * Complete a baseline assessment including demographic information, measures of hope, general mental health and functioning, alcohol use, suicide ideation, cultural stress, and beliefs about treatment. * Receive Deaf CBT-TS (2 sessions) or be placed on a waitlist with the option of receiving Deaf CBT-Ts after 4 months * Complete two follow-up assessments in 2 and 4 months.

Waitlist Available
Has No Placebo

University of Rochester Medical Center

Image of Sunwise Clinical Research /ID# 277555 in Walnut Creek, United States.

Icalcaprant for Depression

18 - 65
All Sexes
Walnut Creek, CA

Major depressive disorder (MDD; depression) is a mood disorder that causes a continued feeling of sadness and loss of interest. It is a common and serious illness that can cause both emotional and physical symptoms such as feelings of sadness, irritability, not being able to focus on activities, tiredness, changes in eating habits, and aches and pains. This study will assess the changes in disease activity and adverse events of oral Icalcaprant in adult participants with major depressive disorder who are currently experiencing a major depressive episode (MDE). Icalcaprant is an investigational drug being developed for the treatment of depressive episodes in adult participants with major depressive disorder. Participants are placed in 1 of 3 groups, called treatment arms. There is a 1 in 3 chance that a participant will be assigned to placebo treatment. Around 195 adult participant with major depressive disorder will be enrolled in approximately 35 sites in North America. Participants will receive oral capsules of Icalcaprant or matching placebo once daily for 6 weeks, with a 30-day safety follow-up. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Phase 2
Recruiting

Sunwise Clinical Research /ID# 277555 (+12 Sites)

ABBVIE INC.

AbbVie

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We made a collection of clinical trials featuring Spravato, we think they might fit your search criteria.
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