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SEROQUEL

Phase 3

Bipolar Disorder | Small molecule | Psychiatry |AstraZeneca PLC|Last Updated: Jan 4, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment -

FDA Designations

No designations recorded

Clinical trial landscape

SEROQUEL · 5 trials · 4 indications

Phase 3 4Phase 1 1
NCT00228462Relapse Prevention, RoW: Study to Evaluate Prevention of Relapse in Patients in Stable Chronic Schizophrenia Receiving Either Seroquel or PlaceboSchizophrenia
COMPLETED197 Analytics
NCT00206128Immediate Release (IR) to Sustained Release (SR) Switching Study: Study of Switching From IR Seroquel to SR Seroquel in Outpatients With SchizophreniaSchizophrenia
COMPLETED454 Analytics
NCT00234377Seroquel Switching Study: Feasibility of Switching Any Antipsychotic Treatment to Seroquel in Patients With SchizophreniaSchizophrenia
COMPLETED550 Analytics
NCT00060489Safety and Efficacy Trial of the Use of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Patients With Bipolar DepressionBipolar Disorder
COMPLETED- Analytics
PHASE3COMPLETED
Relapse Prevention, RoW: Study to Evaluate Prevention of Relapse in Patients in Stable Chronic Schizophrenia Receiving Either Seroquel or Placebo
Schizophrenia
NCT00228462197
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PHASE3COMPLETED
Immediate Release (IR) to Sustained Release (SR) Switching Study: Study of Switching From IR Seroquel to SR Seroquel in Outpatients With Schizophrenia
Schizophrenia
NCT00206128454
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PHASE3COMPLETED
Seroquel Switching Study: Feasibility of Switching Any Antipsychotic Treatment to Seroquel in Patients With Schizophrenia
Schizophrenia
NCT00234377550
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PHASE3COMPLETED
Safety and Efficacy Trial of the Use of Quetiapine Fumarate (SEROQUEL®) in the Treatment of Patients With Bipolar Depression
Bipolar Disorder
NCT00060489-
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Study Endpoints

Primary Endpoints

The primary objective in this study is to demonstrate superior efficacy of quetiapine to placebo by evaluating relapse prevention in long-term use in patients with schizophrenia as measured by the time to first psychiatric relapse up to one year
The proportion of patients who discontinue study treatment due to lack of efficacy or whose positive and negative syndrome scale (PANSS) total score increases 20% or more
from randomisation to any visit
The proportion of patients who have an improved clinical benefit based on assessment of clinical efficacy in combination with assessment of tolerability
Positron emission tomography using the radioligand [11C]raclopride
5 visits

Secondary Endpoints

To demonstrate superiority of quetiapine to placebo by evaluating the risk of relapse in long-term use in patients with schizophrenia by evaluating the one-year relapse rate
The change in PANSS total score
from randomization to week 6
The change in PANSS positive, negative and general psychopathology symptoms subscale scores respectively
from randomization to week 6
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATOR -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Seroquel (quetiapine)DRUG -
Seroquel SRDRUG -
SEROQUEL (quetiapine fumarate) TabletsDRUG -
SEROQUEL XR (quetiapine)DRUGrepeated dose of oral tablets, 8 times per subject
SEROQUEL IR (quetiapine)DRUGrepeated dose of oral tablets, 4 times per subject
radioligand [11C]racloprideDRUGsingle dose of iv admin, 5 times per subject
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Stable schizophrenic patients who have provided written informed consent * Patients 18 to 65 years old who remain clinically stable after switching to a stable dose of Seroquel (quetiapine). Exclusion Criteria: * Patients with risk of suicide, other disorders or substance ab...

Countries:BulgariaPolandUnited StatesAustraliaCanadaEstoniaFinlandGermanyHungaryItalyLatviaLithuaniaSpainSweden
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Competitive Landscape -Bipolar Disorder 20 trials

CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY4PHASE3KarXT
AbbVie, Inc.ABBV3PHASE3Cariprazine
Alkermes Public Limited CompanyALKS2PHASE3OLZ/SAM
Xenon Pharmaceuticals Inc.XENE2PHASE3Azetukalner
Eli Lilly and CompanyLLY1PHASE2Brenipatide
Rapport Therapeutics, Inc.RAPP1PHASE2RAP-219
Neurocrine Biosciences, Inc.NBIX1PHASE2NBI-1117568
Alto Neuroscience, Inc.ANRO1PHASE2ALTO-100
LB Pharmaceuticals, Inc.LBRX1PHASE2LB-102
BioXcel Therapeutics, Inc.BTAI1PHASE1BXCL501 80 Micrograms, BXCL501 120 Micrograms, BXCL501 60 Micrograms
Alzamend Neuro, Inc.ALZN1PHASE1AL001, Lithium carbonate
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Frequently asked questions about SEROQUEL

What is SEROQUEL used for?

SEROQUEL is an investigational small molecule being developed for depression, schizophrenia, and bipolar disorder. It is in Phase 3 clinical development for these psychiatric conditions. The drug is being studied in patients with schizophrenia and depression, with completed trials evaluating its use in these indications.

What does SEROQUEL target?

SEROQUEL targets the D2 dopamine receptor, as demonstrated in a positron emission tomography (PET) study using [11C]raclopride to determine central D2 dopamine occupancy. This mechanism is relevant to its psychiatric applications in schizophrenia and related conditions.

Who makes SEROQUEL?

SEROQUEL is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. AstraZeneca is conducting clinical trials to evaluate the drug's safety and efficacy in psychiatric indications.

What phase is SEROQUEL in?

SEROQUEL is in Phase 3 clinical development. Three Phase 3 trials have been completed, all focusing on schizophrenia. These trials investigated switching from immediate release to sustained release formulations, relapse prevention, and switching from other antipsychotic treatments.

What clinical trials is SEROQUEL in?

SEROQUEL has completed three Phase 3 trials: NCT00206128 (switching from IR to SR in schizophrenia, 454 patients), NCT00228462 (relapse prevention in stable chronic schizophrenia, 197 patients), and NCT00234377 (switching from any antipsychotic to SEROQUEL, 550 patients). A Phase 1 PET study (NCT00832221) examined D2 occupancy in depression.

Is SEROQUEL the same as quetiapine?

SEROQUEL is a brand name for the drug quetiapine, an atypical antipsychotic. The clinical trials listed under SEROQUEL evaluate this compound in schizophrenia and depression. The drug is being developed by AstraZeneca for psychiatric use.