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Seroquel Sustained Release

Phase 3

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

Success Probability

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment535

FDA Designations

No designations recorded

Clinical trial landscape

Seroquel Sustained Release · 1 trial · 1 indication

Phase 3 1
NCT00206115SR-Registration Study 1, ROW: Efficacy and Safety of Seroquel® in the Treatment of Patients With SchizophreniaSchizophrenic Disorder
COMPLETED535 Analytics
PHASE3COMPLETED
SR-Registration Study 1, ROW: Efficacy and Safety of Seroquel® in the Treatment of Patients With Schizophrenia
Schizophrenic DisorderUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary outcome variable will be the change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at the end of treatment at Day 42.

Secondary Endpoints

Efficacy
To demonstrate a higher PANSS response rate
To demonstrate superior Clinical Global Impressions (CGI) response
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Seroquel Sustained Release (SR)DRUG -
Seroquel Immediate Release (IR)DRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites31

Inclusion Criteria: * To be considered for this study the patients should be aged between 18 to 65 years, need to suffer from schizophrenia and must be willing to participate. Exclusion Criteria: * Patients that suffer from psychiatric disorders other than schizophrenia including drug abuse and d...

Countries:BulgariaGreeceIndiaIndonesiaPhilippinesRomaniaRussiaSouth Africa
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Frequently asked questions about Seroquel Sustained Release

What is Seroquel Sustained Release used for?

Seroquel Sustained Release is an investigational small molecule being studied for the treatment of Schizophrenic Disorder. It is a sustained release formulation of the drug Seroquel, developed by AstraZeneca PLC. The drug is currently in Phase 3 clinical development, meaning it has not yet been approved by regulatory authorities.

How does Seroquel Sustained Release work?

Seroquel Sustained Release is a small molecule antipsychotic. Its mechanism of action involves targeting neurotransmitter receptors in the brain, primarily dopamine and serotonin receptors, which are implicated in the symptoms of schizophrenia. By modulating these receptors, the drug aims to reduce the positive and negative symptoms associated with the disorder.

Who makes Seroquel Sustained Release?

Seroquel Sustained Release is developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the efficacy and safety of this drug for the treatment of Schizophrenic Disorder.

What phase is Seroquel Sustained Release in?

Seroquel Sustained Release is in Phase 3 clinical development. This phase involves large-scale studies to confirm the drug's efficacy, monitor side effects, and compare it with commonly used treatments. As of now, the drug is investigational and has not received FDA approval, as it is still undergoing clinical trials.

What clinical trials is Seroquel Sustained Release in?

Seroquel Sustained Release has one completed Phase 3 clinical trial registered under NCT00206115, titled 'SR-Registration Study 1, ROW: Efficacy and Safety of Seroquel® in the Treatment of Patients With Schizophrenia'. This randomized, double-blind study enrolled 535 participants across multiple countries including Bulgaria, Greece, India, Indonesia, Philippines, Romania, Russia, and South Africa.

Is Seroquel Sustained Release the same as Seroquel?

Seroquel Sustained Release is a sustained release formulation of Seroquel, which is the brand name for quetiapine. The sustained release version is designed to release the medication more slowly in the body, potentially allowing for once-daily dosing. Both are developed by AstraZeneca and are being studied for schizophrenia, but they are distinct formulations.