Who is sponsoring NCT01256177?

NCT01256177 is sponsored by AstraZeneca.

What condition does NCT01256177 study?

NCT01256177 studies Bipolar Depression.

What drugs are being tested in NCT01256177?

Interventions: Quetiapine Fumarate (SEROQUEL) Extended Release, Placebo.

What is the status of NCT01256177?

NCT01256177 is currently COMPLETED.

Last reviewed 2016-03-18 · How we verify

A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients With Bipolar Depression

NCT01256177 Phase 3 COMPLETED Results posted

The primary objective of this study is to evaluate the superior efficacy of quetiapine extended release(XR) mono-therapy, administered once daily compared to placebo, in the treatment of depressive symptoms in patients with Bipolar I and Bipolar II Disorder

Details

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	COMPLETED
Enrolment	361
Start date	2010-12
Completion	2012-11

Conditions

Bipolar Depression

Interventions

Quetiapine Fumarate (SEROQUEL) Extended Release
Placebo

Primary outcomes

Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score — Baseline to Week 8
MADRS total score range: 0 to 60, the higher the score, the more severe, Change : Total MADRS score at week 8 minus score at baseline

Countries

China