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Also known as Quetiapine Fumarate Sustained Release
Quetiapine Sustained Release · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| Quetiapine Fumarate Sustained Release | DRUG | - |
Inclusion Criteria: * Documented clinical diagnosis according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision) meeting criteria 296.2x Major Depressive Disorder, * Single Episode, or 296.3x Major Depressive Disorder, Exclusion Criteria: * Patients ...
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Quetiapine sustained release is being developed as monotherapy for the maintenance treatment of major depressive disorder in adults. It is an extended-release formulation studied in a Phase 3 trial that enrolled 3,000 patients aged 18 and older across the United States, Canada, Europe, and Puerto Rico.
Quetiapine sustained release targets the serotonin 5-HT2A receptor (HTR2A), the dopamine D2 receptor (DRD2), and the serotonin 5-HT2C receptor (HTR2C). It acts as an antagonist at these receptors, a mechanism consistent with its development for major depressive disorder.
Quetiapine sustained release is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is the sponsor of the clinical program evaluating this extended-release formulation for major depressive disorder.
Quetiapine sustained release is in Phase 3 development. It is an investigational product and has not been approved by the FDA for major depressive disorder. The Phase 3 program consists of one completed trial, and no active trials are currently listed.
Quetiapine sustained release has been studied in the Phase 3 trial NCT00278941, titled Quetiapine Fumarate as Monotherapy in the Maintenance Treatment of Patients With Major Depressive Disorder. The trial is completed, enrolled 3,000 participants, and was randomized and double-blind.
Yes, quetiapine sustained release is also known as quetiapine fumarate sustained release. The two names refer to the same extended-release small-molecule product developed by AstraZeneca for major depressive disorder.