CLINICAL TRIALS PROFILE FOR SPRAVATO

All Clinical Trials for SPRAVATO

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT06103760 ↗	Positioning of Esketamine Treatment in the Real-world Management of Depression	Recruiting	Janssen-Cilag Pty Ltd	Phase 4	2023-10-31	The goal of this naturalistic, open label, single arm intervention study is to investigate the effects of Esketamine in treating depression.The main aims to answer are: - to investigate whether Esketamine is effective when added to ongoing antidepressant treatment - to identify patient characteristics that will determine a therapeutic response to Esketamine in real-world practice Participants will: - attend the clinic for supervised self-administration of intranasal Esketamine treatment - be observed for 2 hours following Esketamine administration including blood pressure monitoring - be asked to complete a battery of questionnaires - be reimbursed for travel expenses
NCT06103760 ↗	Positioning of Esketamine Treatment in the Real-world Management of Depression	Recruiting	Royal North Shore Hospital	Phase 4	2023-10-31	The goal of this naturalistic, open label, single arm intervention study is to investigate the effects of Esketamine in treating depression.The main aims to answer are: - to investigate whether Esketamine is effective when added to ongoing antidepressant treatment - to identify patient characteristics that will determine a therapeutic response to Esketamine in real-world practice Participants will: - attend the clinic for supervised self-administration of intranasal Esketamine treatment - be observed for 2 hours following Esketamine administration including blood pressure monitoring - be asked to complete a battery of questionnaires - be reimbursed for travel expenses
NCT05554627 ↗	VA Aripiprazole vs Esketamine for Treatment Resistant Depression	Not yet recruiting	VA Office of Research and Development	Phase 4	2023-03-01	This is an open-label, parallel-group, randomized clinical trial of up to 6 months treatment of adjunctive intranasal (IN) esketamine (ESK) vs. adjunctive aripiprazole (ARI) in Veterans with unipolar Treatment Resistant Depression (TRD). This study will assess the efficacy, safety, and acceptability of adjunctive IN ESK in comparison to ARI, one of the best studied and most widely used adjunctive therapies for TRD. The primary hypothesis is that participants receiving adjunctive IN ESK will be significantly more likely to achieve remission after six weeks of treatment as compared to those who receive adjunctive ARI. Depressive symptoms will be assessed by central raters (CR), blinded to treatment assignment, using the clinician rated version of the Quick Inventory of Depressive Symptomatology (QIDS-C16), a well-validated tool that is commonly used and is easily translated across other depression inventory scales. The study is powered to detect an absolute difference in remission rates of 10%, or larger, at 6 weeks. Additional outcomes of interest include symptom reduction across 6 months of randomized therapy, side effects and other tolerability indices, attrition rates and measures of quality of life and cost-effectiveness.
NCT05323019 ↗	Repeated Intranasal Esketamine Plus Almond Therapy in Patients With Treatment Resistant Depression	Not yet recruiting	Zylorion Health	Phase 2	2022-05-01	To examine the efficacy of Almond Therapy compared to Treatment as Usual when used in addition to an approved version of intranasal esketamine.
NCT05268497 ↗	A Study to Assess Feasibility of Using Clinician-directed and Digital Application Supported Cognitive Behavior Therapy (CBT) in Conjunction With Esketamine in Participants With Treatment-resistant Depression	Not yet recruiting	Janssen Research & Development, LLC	Phase 1	2022-03-14	The purpose of this study is to explore feasibility of combining clinician-directed cognitive behavioral therapy (CBT) supplemented with the Mindset app with esketamine therapy in participants with Treatment-resistant Depression.

Clinical Trial Conditions for SPRAVATO

Condition Name

Condition Name for SPRAVATO
Intervention	Trials
Treatment Resistant Major Depressive Disorder	1
Depression	1
Depressive Disorder, Major	1
Major Depressive Disorder	1

Condition MeSH

Condition MeSH for SPRAVATO
Intervention	Trials
Depressive Disorder	4
Depressive Disorder, Major	3
Depression	3
Depressive Disorder, Treatment-Resistant	1

Clinical Trial Locations for SPRAVATO

Trials by Country

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−

Trials by Country for SPRAVATO
Location	Trials
United States	25
Australia	1

Trials by US State

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−

Trials by US State for SPRAVATO
Location	Trials
Ohio	2
Illinois	2
Connecticut	2
New Mexico	1
Missouri	1

Clinical Trial Progress for SPRAVATO

Clinical Trial Phase

Clinical Trial Phase for SPRAVATO
Clinical Trial Phase	Trials
Phase 4	2
Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for SPRAVATO
Clinical Trial Phase	Trials
Not yet recruiting	3
Recruiting	1

Clinical Trial Sponsors for SPRAVATO

Sponsor Name

Sponsor Name for SPRAVATO
Sponsor	Trials
Janssen Research & Development, LLC	1
Zylorion Health	1
VA Office of Research and Development	1

Sponsor Type

Sponsor Type for SPRAVATO
Sponsor	Trials
Industry	3
U.S. Fed	1
Other	1

SPRAVATO: A Revolutionary Treatment for Depression - Clinical Trials, Market Analysis, and Projections

Introduction to SPRAVATO

SPRAVATO, also known as esketamine, is a groundbreaking medication approved by the FDA for the treatment of treatment-resistant depression (TRD) and depressive symptoms in adults with major depressive disorder (MDD) who have acute suicidal ideation or behavior. This intranasal therapy, derived from ketamine, has been making significant waves in the psychiatric treatment landscape.

Clinical Trials and Efficacy

Rapid Onset and Sustained Improvement

Clinical trials have consistently shown that SPRAVATO, when combined with oral antidepressants, leads to rapid and sustained improvement in depressive symptoms. Patients treated with SPRAVATO demonstrated a significant reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) scores, with a 19.8-point reduction after four weeks, which is nearly five points higher than those treated with oral antidepressants alone[1][4].

Monotherapy Trials

Recent Phase 4 trials have evaluated SPRAVATO as a monotherapy for adults with TRD. These studies showed rapid improvement in depressive symptoms as early as 24 hours after the first dose, with sustained effects through at least four weeks. The safety profile of SPRAVATO monotherapy was consistent with existing data, and no new safety concerns were identified[3][4].

Real-World Evidence

Real-world studies have reinforced the efficacy and safety of SPRAVATO. A retrospective observational study using data from health insurance claims and clinical observations found significant improvements in Patient-Reported Outcome (PRO) scores, including PHQ-9, HRSD, BDI-II, and QIDS-SR16, among patients with MDD and TRD[5].

Market Analysis

Sales Performance

SPRAVATO has been performing exceptionally well in the market. In the second quarter of 2024, global sales of SPRAVATO totaled $271 million, representing a 61% increase from the same period the previous year and a 20% jump from the first quarter. This growth is attributed to increased physician and patient confidence in the drug[2].

Revenue Projections

Johnson & Johnson anticipates that SPRAVATO sales will continue to grow, projecting annual revenues to reach between $1 billion and $5 billion. The strong sales trajectory supports the commercial viability of psychedelics in mental health treatment, with analysts like Andrew Tsai from Jefferies noting that SPRAVATO's success could bode well for other brain drugs in the same category[2].

Market Impact and Competitive Landscape

Market Significance

SPRAVATO's approval and success mark a significant shift in the treatment of depression, particularly for those with treatment-resistant depression. It is the first FDA-approved intranasal therapy for this condition and has been administered to over 100,000 people worldwide, approved in 77 countries[4].

Competitive Landscape

The success of SPRAVATO is part of a broader trend in the development of psychedelic-assisted therapies. Companies like Compass Pathways and Atai Life Sciences are also working on treatments using psilocybin and dimethyltryptamine, respectively, for treatment-resistant depression. However, the field is closely watched by regulatory bodies, as evidenced by the recent FDA advisory committee's recommendation to delay approval for MDMA-assisted therapy due to safety and trial conduct issues[2].

Safety and Administration

Supervised Use

Due to the risk of dissociation and suicidal thoughts, SPRAVATO is only available for use under the supervision of a healthcare professional in a medical office or clinic. This ensures that patients are monitored closely during and after administration[2][4].

Safety Profile

The safety profile of SPRAVATO has been extensively studied, and the data from both clinical trials and real-world use have been consistent. No new safety concerns were identified in the recent monotherapy trials, reinforcing the existing body of clinical data[3][4].

Future Directions

Monotherapy Approval

Johnson & Johnson has submitted a supplemental New Drug Application (sNDA) to the FDA seeking approval of SPRAVATO as a monotherapy for adults with TRD. This submission is supported by positive results from Phase 4 trials, which could expand the treatment options for patients who have not responded to other antidepressants[3][4].

Ongoing Research

In addition to SPRAVATO, Johnson & Johnson is developing other depression treatments, including seltorexant and aticaprant, which have shown promising results in clinical studies. This continued research focus in neuroscience underscores the company's commitment to addressing the complex needs of patients with depression[2].

Key Takeaways

• Rapid Efficacy: SPRAVATO shows rapid improvement in depressive symptoms, often within 24 hours, and sustained effects over several weeks.
• Clinical Trials: Both combination therapy and monotherapy trials have demonstrated significant reductions in MADRS scores and other PRO scores.
• Market Performance: SPRAVATO sales are growing rapidly, with projections indicating it could reach $1 billion to $5 billion in annual revenue.
• Safety: The drug is administered under medical supervision due to potential risks, but its safety profile is well-documented and consistent.
• Future Directions: Pending FDA approval for monotherapy use and ongoing research into other novel treatments.

FAQs

What is SPRAVATO and how is it administered?

SPRAVATO is an intranasal therapy derived from esketamine, administered via a nasal spray. It is used under the supervision of a healthcare professional in a medical office or clinic.

What conditions is SPRAVATO approved for?

SPRAVATO is approved for treating treatment-resistant depression (TRD) and depressive symptoms in adults with major depressive disorder (MDD) who have acute suicidal ideation or behavior.

How quickly does SPRAVATO show improvement in depressive symptoms?

Clinical trials have shown that SPRAVATO can lead to significant improvement in depressive symptoms as early as 24 hours after the first dose, with sustained effects over at least four weeks.

What are the potential risks associated with SPRAVATO?

SPRAVATO can cause dissociation and suicidal thoughts, which is why it is only available for use under the supervision of a healthcare professional.

How is SPRAVATO performing in the market?

SPRAVATO sales have been increasing significantly, with a 61% increase in the second quarter of 2024 compared to the same period the previous year, and projections indicate it could reach $1 billion to $5 billion in annual revenue.

What other treatments is Johnson & Johnson developing for depression?

Johnson & Johnson is developing other depression treatments, including seltorexant and aticaprant, which have shown promising results in clinical studies.

Sources

1. Revitalizing Infusion Therapies - SPRAVATO™ Clinical Studies
2. Yahoo Finance - Strengthening Spravato sales a positive sign for psychedelic drugs
3. PR Newswire - Johnson & Johnson seeks U.S. FDA approval of SPRAVATO® (esketamine) as the first and only monotherapy for adults with treatment-resistant depression
4. Johnson & Johnson - Johnson & Johnson seeks U.S. FDA approval of SPRAVATO® (esketamine) as the first and only monotherapy for adults with treatment-resistant depression
5. Janssen Science - Real World Evidence – Effectiveness and Safety of SPRAVATO® (esketamine)