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Last Updated: March 17, 2025

CLINICAL TRIALS PROFILE FOR SEROQUEL


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All Clinical Trials for SEROQUEL

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00048802 ↗ Treatment and Outcome of Early Onset Bipolar Disorder Completed National Institute of Mental Health (NIMH) Phase 4 2002-08-01 This study will compare the effectiveness in the maintenance of continuing adjunctive atypical antipsychotic medication compared to traditional mood stabilizer(s) alone in the maintenance treatment of adolescents with bipolar disorder.
NCT00048802 ↗ Treatment and Outcome of Early Onset Bipolar Disorder Completed Northwell Health Phase 4 2002-08-01 This study will compare the effectiveness in the maintenance of continuing adjunctive atypical antipsychotic medication compared to traditional mood stabilizer(s) alone in the maintenance treatment of adolescents with bipolar disorder.
NCT00043849 ↗ Treatment of Agitation/Psychosis in Dementia/Parkinsonism (TAP/DAP) Completed National Institute on Aging (NIA) Phase 4 2002-07-01 The primary aim of this study is to determine the safety and efficacy of quetiapine (Seroquel) for the treatment of psychosis and/or agitation in patients with primary dementia complicated by coexistent parkinsonism, or patients with Parkinson's disease with dementia [PDD] who have episodes of agitation or psychosis. The secondary aim is to determine the safety and tolerability, particularly the influence on parkinsonism, of quetiapine when used to treat psychosis and/or agitation in patients with dementia complicated by coexistent parkinsonism.
NCT00034905 ↗ A Comparison of Seroquel vs. Risperidone in Schizophrenia Completed AstraZeneca Phase 4 2001-07-01 The purpose of this study is to show equal efficacy of both quetiapine and risperidone in subjects treated with study medication for up to 8 weeks.
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.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 6 of 6 entries

Clinical Trial Conditions for SEROQUEL

Condition Name

47321710005101520253035404550SchizophreniaBipolar DisorderMajor Depressive DisorderGeneralized Anxiety Disorder[disabled in preview]
Condition Name for SEROQUEL
Intervention Trials
Schizophrenia 47
Bipolar Disorder 32
Major Depressive Disorder 17
Generalized Anxiety Disorder 10
[disabled in preview] 0
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Condition MeSH

6251484300102030405060DiseaseSchizophreniaBipolar DisorderDepression[disabled in preview]
Condition MeSH for SEROQUEL
Intervention Trials
Disease 62
Schizophrenia 51
Bipolar Disorder 48
Depression 43
[disabled in preview] 0
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Clinical Trial Locations for SEROQUEL

Trials by Country

+
Trials by Country for SEROQUEL
Location Trials
United States 764
Canada 85
Italy 44
China 36
Korea, Republic of 23
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Trials by US State

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Trials by US State for SEROQUEL
Location Trials
New York 41
California 40
Texas 38
Ohio 34
Pennsylvania 32
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Clinical Trial Progress for SEROQUEL

Clinical Trial Phase

43.8%36.7%18.3%001020304050607080Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for SEROQUEL
Clinical Trial Phase Trials
Phase 4 74
Phase 3 62
Phase 2/Phase 3 2
[disabled in preview] 31
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Clinical Trial Status

77.0%11.0%6.8%5.2%0020406080100120140160CompletedTerminatedUnknown status[disabled in preview]
Clinical Trial Status for SEROQUEL
Clinical Trial Phase Trials
Completed 147
Terminated 21
Unknown status 13
[disabled in preview] 10
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Clinical Trial Sponsors for SEROQUEL

Sponsor Name

trials0102030405060708090100AstraZenecaNational Institute of Mental Health (NIMH)National Institute on Drug Abuse (NIDA)[disabled in preview]
Sponsor Name for SEROQUEL
Sponsor Trials
AstraZeneca 93
National Institute of Mental Health (NIMH) 7
National Institute on Drug Abuse (NIDA) 7
[disabled in preview] 13
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Sponsor Type

49.3%40.5%7.0%0020406080100120140OtherIndustryNIH[disabled in preview]
Sponsor Type for SEROQUEL
Sponsor Trials
Other 140
Industry 115
NIH 20
[disabled in preview] 9
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SEROQUEL: Clinical Trials, Market Analysis, and Projections

Introduction to SEROQUEL

SEROQUEL, also known by its generic name quetiapine fumarate, is an atypical antipsychotic medication widely used in the treatment of various psychiatric conditions. This article will delve into the clinical trials, market analysis, and future projections for SEROQUEL.

Clinical Indications and Efficacy

SEROQUEL is indicated for several psychiatric conditions, including:

Schizophrenia

  • Efficacy in adults was established in three 6-week clinical trials, and in adolescents (ages 13-17) in one 6-week trial[1][3].

Bipolar Disorder

  • It is used for the acute treatment of manic or mixed episodes, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in several trials, including a 3-week trial in adults and a 3-week monotherapy trial in children and adolescents (ages 10-17)[1][3].
  • Additionally, SEROQUEL is indicated for the acute treatment of depressive episodes associated with bipolar I or II disorder, supported by two 8-week trials in adults[1][3].

Adjunctive Treatment of Major Depressive Disorder (MDD)

  • SEROQUEL is used as adjunctive therapy to antidepressants for the treatment of MDD, with efficacy established in two 6-week trials in adults who had an inadequate response to antidepressant treatment[1].

Clinical Trials Overview

Schizophrenia Trials

  • Three 6-week clinical trials in adults and one 6-week trial in adolescents demonstrated the efficacy of SEROQUEL in treating schizophrenia[3].

Bipolar Disorder Trials

  • Multiple trials, including 12-week monotherapy trials and 3-week adjunctive trials, have supported the use of SEROQUEL in treating manic episodes associated with bipolar I disorder. Additionally, an 8-week trial established its efficacy in treating depressive episodes associated with bipolar disorder[1][3].

Specific Trial: Phase III Study for Bipolar Depression

  • A multicenter, double-blind, randomized, parallel-group, placebo-controlled Phase III study (D144CC00002) evaluated the safety and efficacy of sustained-release quetiapine fumarate (Seroquel SR) as monotherapy in adult patients with acute bipolar depression. This study aimed to assess the efficacy and safety of SEROQUEL in this specific patient population[4].

Market Analysis and Projections

Current Market Size

  • The quetiapine market, which includes SEROQUEL, was valued at USD 16.11 billion in 2023[2].

Growth Projections

  • The market is projected to reach USD 26.45 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.2% from 2024 to 2031. This growth is driven by factors such as advancements in drug delivery systems, regulatory approvals for new indications, favorable insurance coverage, and updates in clinical practice guidelines[2].

Global Antipsychotic Drugs Market

  • The broader global antipsychotic drugs market is expected to grow at a CAGR of around 2.5% to reach approximately $14.91 billion by 2025. This growth is influenced by market trends, technological innovations, and key developments in the antipsychotic drug sector[5].

Factors Influencing Market Growth

Regulatory Approvals

  • Health authorities’ approvals for new indications or formulations of quetiapine can significantly influence market dynamics, creating new opportunities in various segments[2].

Insurance Coverage and Reimbursement Policies

  • Favorable insurance coverage and reimbursement policies for quetiapine can encourage prescribing by healthcare providers and increase patient access to the medication[2].

Treatment Guidelines

  • Updates in clinical practice guidelines that support the use of quetiapine in specific conditions can drive its demand among healthcare professionals[2].

Safety and Dosing Considerations

Dose Modifications

  • When used with potent CYP3A4 inducers, the dose of SEROQUEL XR should be increased up to 5-fold of the original dose and titrated based on clinical response and tolerance. The dose should be reduced to the original level within 7-14 days after discontinuation of the CYP3A4 inducer[1].

Safety Precautions

  • SEROQUEL is associated with several safety precautions, including the risk of hyperprolactinemia, leukopenia, neutropenia, agranulocytosis, and cataracts. Regular monitoring and examinations are recommended to manage these risks[3].

Key Takeaways

  • Clinical Efficacy: SEROQUEL has been proven effective in treating schizophrenia, bipolar disorder, and as an adjunctive therapy for major depressive disorder through numerous clinical trials.
  • Market Growth: The quetiapine market is projected to grow significantly, driven by advancements in drug delivery, regulatory approvals, and favorable insurance coverage.
  • Safety Considerations: Healthcare providers must be aware of the potential side effects and take necessary precautions to ensure patient safety.
  • Future Projections: The market is expected to reach USD 26.45 billion by 2031, indicating a strong future for SEROQUEL and similar antipsychotic medications.

FAQs

What are the primary indications for SEROQUEL?

SEROQUEL is primarily indicated for the treatment of schizophrenia, acute treatment of manic or mixed episodes associated with bipolar I disorder, acute treatment of depressive episodes associated with bipolar disorder, and as an adjunctive therapy to antidepressants for major depressive disorder.

How does the dose of SEROQUEL need to be adjusted when used with CYP3A4 inducers?

The dose of SEROQUEL XR should be increased up to 5-fold of the original dose when used with potent CYP3A4 inducers and reduced to the original level within 7-14 days after discontinuation of the CYP3A4 inducer.

What are the potential side effects of SEROQUEL?

SEROQUEL is associated with several potential side effects, including hyperprolactinemia, leukopenia, neutropenia, agranulocytosis, and cataracts.

What is the projected market size for quetiapine by 2031?

The quetiapine market is projected to reach USD 26.45 billion by 2031, growing at a CAGR of 5.2% from 2024 to 2031.

What factors are driving the growth of the quetiapine market?

The growth of the quetiapine market is driven by advancements in drug delivery systems, regulatory approvals for new indications, favorable insurance coverage, and updates in clinical practice guidelines.

Sources

  1. Drugs.com: SEROQUEL XR: Package Insert / Prescribing Information.
  2. Verified Market Research: Quetiapine Market Size, Share, Scope, Trends & Forecast.
  3. FDA: Approval Package - SEROQUEL.
  4. AstraZeneca Clinical Trials: Phase III/Seroquel SR Bipolar Depression Monotherapy.
  5. Business Wire: Global Antipsychotic Drugs Market Analysis & Trends 2014-2016.

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