EU Clinical Trial Information System (CTIS)

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

The purpose of this study is to determine whether quetiapine is effective and safe in the acute treatment of bipolar depression and whether the effect is maintained when treatment is continued.

Seroquel in Bipolar Depression versus SSRI

AstraZeneca Clinical Trial Information – Outside US

Research Site

Multicentre, double-blind, randomised, parallel group, placebo controlled, phase 3 study of the efficacy & safety of quetiapine fumarate & paroxetine as monotherapy in adult patients with bipolar depression for 8 weeks & quetiapine in continuation (Abbreviated)

Seroquel in Bipolar Depression versus SSRI - EMBOLDEN II

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Documents available

AstraZeneca Clinical Trial Information – Outside US

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1779&filename=CSR-D1447C00134.pdf

CSR-D1447C00134.pdf

Trial Results Summaries

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Principal Investigator