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Last Updated: May 21, 2025

CLINICAL TRIALS PROFILE FOR RISPERDAL CONSTA


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All Clinical Trials for Risperdal Consta

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00044655 ↗ Switching Medication to Treat Schizophrenia Completed National Institute of Mental Health (NIMH) Phase 4 2001-07-01 This study will evaluate the effectiveness of switching medications in decreasing schizophrenia symptoms in individuals who are currently taking an antipsychotic medication for the treatment of schizophrenia.
NCT00044655 ↗ Switching Medication to Treat Schizophrenia Completed Icahn School of Medicine at Mount Sinai Phase 4 2001-07-01 This study will evaluate the effectiveness of switching medications in decreasing schizophrenia symptoms in individuals who are currently taking an antipsychotic medication for the treatment of schizophrenia.
NCT00094926 ↗ A Study of Effectiveness and Safety of Risperdal CONSTA Added to Usual Treatment in Patients With Bipolar Disorder Who Have Frequent Mood Episodes. Completed Janssen, LP Phase 3 2004-05-01 The purpose of this study is to examine the safety and effectiveness of the long acting injectable form of the atypical antipsychotic Risperidone (Risperdal CONSTA), along with treatment as usual (TAU), in bipolar disorder patients who had more than 4 mood episodes in the past year.
NCT00094926 ↗ A Study of Effectiveness and Safety of Risperdal CONSTA Added to Usual Treatment in Patients With Bipolar Disorder Who Have Frequent Mood Episodes. Completed Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Phase 3 2004-05-01 The purpose of this study is to examine the safety and effectiveness of the long acting injectable form of the atypical antipsychotic Risperidone (Risperdal CONSTA), along with treatment as usual (TAU), in bipolar disorder patients who had more than 4 mood episodes in the past year.
NCT00130923 ↗ Risperidone Long-acting Versus Oral Risperidone in Patients With Schizophrenia and Alcohol Use Disorder Completed Janssen, LP Phase 4 2005-09-01 The purpose of this study is to compare the efficacy of oral risperidone (Risperdal) to risperidone long-acting (Consta) in reducing alcohol use in persons diagnosed with schizophrenia or schizoaffective disorder.
NCT00130923 ↗ Risperidone Long-acting Versus Oral Risperidone in Patients With Schizophrenia and Alcohol Use Disorder Completed Dartmouth-Hitchcock Medical Center Phase 4 2005-09-01 The purpose of this study is to compare the efficacy of oral risperidone (Risperdal) to risperidone long-acting (Consta) in reducing alcohol use in persons diagnosed with schizophrenia or schizoaffective disorder.
NCT00132678 ↗ A Study of the Safety and Efficacy of Injectable Risperidone in the Prevention of Bipolar Mood Episodes Completed Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Phase 3 2005-02-01 The purpose of this study is to determine if risperidone is effective and safe in the prevention of mood episodes in patients with bipolar 1 disorder.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Risperdal Consta

Condition Name

Condition Name for Risperdal Consta
Intervention Trials
Schizophrenia 37
Schizoaffective Disorder 13
Psychotic Disorders 9
Bipolar Disorder 4
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Condition MeSH

Condition MeSH for Risperdal Consta
Intervention Trials
Schizophrenia 37
Psychotic Disorders 22
Disease 14
Mental Disorders 10
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Clinical Trial Locations for Risperdal Consta

Trials by Country

Trials by Country for Risperdal Consta
Location Trials
United States 90
Canada 13
Poland 4
Spain 4
Malaysia 4
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Trials by US State

Trials by US State for Risperdal Consta
Location Trials
California 11
Georgia 7
Texas 6
Pennsylvania 5
Florida 5
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Clinical Trial Progress for Risperdal Consta

Clinical Trial Phase

Clinical Trial Phase for Risperdal Consta
Clinical Trial Phase Trials
Phase 4 21
Phase 3 15
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Risperdal Consta
Clinical Trial Phase Trials
Completed 42
Terminated 3
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Clinical Trial Sponsors for Risperdal Consta

Sponsor Name

Sponsor Name for Risperdal Consta
Sponsor Trials
Janssen, LP 10
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 10
National Institute of Mental Health (NIMH) 4
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Sponsor Type

Sponsor Type for Risperdal Consta
Sponsor Trials
Industry 47
Other 17
NIH 4
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RISPERDAL CONSTA: Clinical Trials, Market Analysis, and Projections

Introduction to RISPERDAL CONSTA

RISPERDAL CONSTA, a long-acting injectable form of risperidone, has been a significant player in the treatment of schizophrenia and bipolar I disorder. Developed using Alkermes’ proprietary Medisorb drug-delivery technology, this medication is administered via intramuscular injection once every two weeks, ensuring consistent release of the active metabolite over a prolonged period.

Clinical Trials and Efficacy

Schizophrenia Trials

The efficacy of RISPERDAL CONSTA in treating schizophrenia was established through several clinical trials. A pivotal 12-week, double-blind, placebo-controlled trial demonstrated significant improvements in patients treated with RISPERDAL CONSTA compared to those receiving a placebo. The trial, which included doses of 25 mg, 50 mg, and 75 mg given every two weeks, showed that RISPERDAL CONSTA significantly reduced the Positive and Negative Syndrome Scale (PANSS) total scores and improved Clinical Global Impression (CGI) ratings[4].

In a broader analysis, two prospective, observational two-year studies conducted in the U.S. and other countries found that patients treated with RISPERDAL CONSTA experienced significant improvements in clinical and functional outcomes, including a reduction in psychiatric hospitalizations and an improvement in the Global Assessment of Functioning (GAF) scores[3].

Bipolar I Disorder Trials

For bipolar I disorder, RISPERDAL CONSTA was approved as both a monotherapy and an adjunctive therapy to lithium or valproate. Two prospective, randomized, double-blind, placebo-controlled studies demonstrated that RISPERDAL CONSTA significantly delayed the time to relapse of any mood episode when used as a monotherapy and as an adjunct to existing treatments[1].

Adverse Reactions and Safety Profile

The safety profile of RISPERDAL CONSTA includes several common adverse reactions. In schizophrenia trials, these reactions included headache, muscle stiffness, dizziness, restlessness, tiredness, constipation, indigestion, sedation, weight increase, pain in extremity, and dry mouth. For patients with bipolar disorder, weight increase and tremor/parkinsonism were notable adverse reactions, particularly in adjunctive therapy trials[1].

Market Analysis

Commercial Success

RISPERDAL CONSTA has been a commercial success, with global sales reaching $780 million in 2008. Its success can be attributed to improved patient compliance, a crucial factor in the treatment of mental health disorders. The depot formulation ensures that the medication is consistently delivered, reducing the risk of non-adherence[2].

Market Evolution

The antipsychotic market is evolving, with long-acting injectable formulations like RISPERDAL CONSTA and Invega Sustenna driving this change. These formulations offer superior dosing regimens and improved compliance, making them attractive alternatives to traditional oral medications. However, the market is expected to face challenges due to patent expirations and the subsequent introduction of generic versions, which could impact sales growth[2][5].

Projections and Future Outlook

Generic Erosion

The patents protecting RISPERDAL CONSTA, along with other major antipsychotic brands, are due to expire in the coming years. This is expected to lead to significant generic erosion in the market, particularly in regions like the 5EU, where generic competition is anticipated to limit sales growth. By 2025, the schizophrenia market in the 5EU is expected to be widely genericized, affecting the sales of branded drugs like RISPERDAL CONSTA[5].

Competitive Landscape

Despite the challenges posed by generic competition, Johnson & Johnson, the manufacturer of RISPERDAL CONSTA, remains well-positioned due to its experience and network in the antipsychotic market. The introduction of follow-on products like Invega Sustenna, which offers a once-per-month dosing regimen, is expected to enhance the company's antipsychotic franchise and provide an alternative to established brands[2].

Impact on Patient Care

Improved Compliance

One of the significant benefits of RISPERDAL CONSTA is its ability to ensure uninterrupted medication delivery, which is crucial for patients with schizophrenia and bipolar I disorder. This long-acting formulation helps in reducing the risk of relapse and hospitalization, thereby improving the overall quality of life for patients[1][3].

Clinical Outcomes

Studies have consistently shown that RISPERDAL CONSTA improves clinical and functional outcomes for patients. For example, a two-year observational study found that patients treated with RISPERDAL CONSTA experienced a significant reduction in CGI-S scores and an improvement in GAF scores, indicating better clinical and functional outcomes[3].

Conclusion

RISPERDAL CONSTA has established itself as a valuable treatment option for schizophrenia and bipolar I disorder, offering improved patient compliance and significant clinical benefits. While the market faces challenges from generic competition, the drug's efficacy and the strategic positioning of its manufacturer are expected to maintain its relevance in the antipsychotic market.

Key Takeaways

  • Efficacy in Schizophrenia and Bipolar I Disorder: RISPERDAL CONSTA has demonstrated significant efficacy in clinical trials for both schizophrenia and bipolar I disorder.
  • Improved Patient Compliance: The long-acting injectable formulation ensures consistent medication delivery, reducing the risk of non-adherence.
  • Market Success: RISPERDAL CONSTA has been commercially successful, with global sales reaching $780 million in 2008.
  • Generic Erosion: The market is expected to face generic competition as patents expire, affecting sales growth.
  • Clinical Outcomes: Studies have shown that RISPERDAL CONSTA improves clinical and functional outcomes for patients.

FAQs

What is RISPERDAL CONSTA used for?

RISPERDAL CONSTA is used for the treatment of schizophrenia and bipolar I disorder. It is administered as a long-acting injectable formulation to ensure consistent medication delivery.

How is RISPERDAL CONSTA administered?

RISPERDAL CONSTA is administered via intramuscular injection once every two weeks. It uses Alkermes’ proprietary Medisorb drug-delivery technology to encapsulate risperidone in microspheres made of a biodegradable polymer.

What are the common adverse reactions associated with RISPERDAL CONSTA?

Common adverse reactions include headache, muscle stiffness, dizziness, restlessness, tiredness, constipation, indigestion, sedation, weight increase, pain in extremity, and dry mouth. For bipolar disorder, weight increase and tremor/parkinsonism are also notable.

How has RISPERDAL CONSTA impacted patient care?

RISPERDAL CONSTA has improved patient care by ensuring uninterrupted medication delivery, reducing the risk of relapse and hospitalization, and improving overall clinical and functional outcomes.

What are the market projections for RISPERDAL CONSTA?

The market for RISPERDAL CONSTA is expected to face challenges due to generic erosion as patents expire. However, Johnson & Johnson's experience and network in the antipsychotic market are expected to help maintain the drug's relevance.

How does RISPERDAL CONSTA compare to other antipsychotic treatments?

RISPERDAL CONSTA offers improved patient compliance and a superior dosing regimen compared to traditional oral medications. It is also the first and only long-acting atypical antipsychotic therapy available for bipolar I disorder.

Sources

  1. FDA Grants Approval for Use of RISPERDAL(R) CONSTA(R) as Both Monotherapy and Adjunctive Therapy to Lithium or Valproate in the Maintenance Treatment of Bipolar I Disorder. Alkermes Investor Relations.
  2. Pipeline antipsychotic drugs to drive next market evolution. Healthcare Finance News.
  3. New Data Demonstrate RISPERDAL(R) CONSTA(R) (Risperidone) Long-Acting Treatment (RLAT) May Improve Clinical and Functional Outcomes and Reduce Rates of Rehospitalization Among Patients with Schizophrenia. Alkermes Investor Relations.
  4. Clinical Overview of RISPERDAL CONSTA. Janssen Science.
  5. Schizophrenia - 5EU Drug Forecast and Market Analysis to 2025. Business Wire.
Last updated: 2025-01-01

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