Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression (QUALITY)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Acute Bipolar Depression

Treatments: Drug: Quetiapine fumarate XR; Drug: Lithium carbonate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00883493

D1443L00055

Details and patient eligibility

About

The purpose of this study is to compare the efficacy of quetiapine fumarate monotherapy with quetiapine fumarate in combination with lithium in the treatment of a major depressive episode in patients with bipolar disorder.

Enrollment: 421 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Outpatients that meet the diagnostic criteria for bipolar disorder I and bipolar disorder II with the most recent episode depressed
• The total score of the scale that's used for the evaluation of depression (HAM-D) should be ≥20
• The total score of the scale that' used for the evaluation of mania (YMRS) should be ≤12

Exclusion criteria

• Patients with a current DSM-IV-TR Axis I disorder other than bipolar disorder within 6 months of enrollment. Patients who pose a current serious suicidal or homicidal risk
• Use of drugs that induce or inhibit the hepatic metabolizing enzymes within 14 days before randomisation
• Patients who are unable to discontinue all psychoactive medications, including antidepressants, antipsychotics, and mood stabilizers at least 7 days prior to randomisation and consistent with the pharmacokinetics of the drug

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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421 participants in 2 patient groups

Quetiapin fumarate XR

Experimental group

Description:

Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.

Treatment:

Drug: Quetiapine fumarate XR

Quetiapin fumarate XR+Lithium carbonate

Experimental group

Description:

Quetiapine XR will be administered like monotherapy arm. Lithium will be administered twice daily from Day 1 to Day 56.

Treatment:

Drug: Lithium carbonate

Drug: Quetiapine fumarate XR