Seroquel in Bipolar Depression Versus Lithium

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Bipolar Disorder

Bipolar Depression

Depression

Treatments

Drug: Quetiapine Fumarate (Seroquel™) drug, mood stabilizer (mood)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00206141

D1447C00001

EMBOLDEN I

Details and patient eligibility

About

This study is being carried out to see if quetiapine fumarate (Seroquel) is effective in treating bipolar depression during an 8-week acute phase compared with placebo and lithium, followed by continuation treatment for 26 up to 52 with quetiapine fumarate (Seroquel) compared to placebo.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with a diagnosis of bipolar I disorder or bipolar II disorder, currently depressed, aged 18 to 65 years old and outpatient status at enrolment and randomization.

Exclusion criteria

Patients with a current DSM-IV Axis I disorder other than bipolar disorder that is symptomatic or requiring treatment within 6 months of enrolment,
History of non-response to an adequate treatment
Patients who, in the investigator's judgment pose a current serious suicidal or homicidal risk
Pregnancy or lactation
Clinically relevant disease or clinical finding