Official Title: “A Randomised, Multi-Centre Study to Compare the Efficacy and Safety of Extended Release Quetiapine Fumarate (Seroquel XR TM) Tablets as Mono-Therapy or in Combination With Lithium in the Treatment of Patients With Acute Bipolar Depression”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Quetiapine fumarate XR
  • 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.
• Drug: Lithium carbonate
  • Twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose of lithium could be increased gradually within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose could be adjusted from 600 to 1800 mg/day

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Quetiapin fumarate XR
  • 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.
• Experimental: Quetiapin fumarate XR+Lithium carbonate
  • Quetiapine XR will be administered like monotherapy arm. Lithium will be administered twice daily from Day 1 to Day 56.

Primary Measures

• The primary outcome variable of the study is the change from baseline in the MADRS total score to Day 56.
  • Time Frame: Days 1, 8, 15, 22, 29, 36, 43, 50, 56
    Safety Issue?: No

Secondary Measures

• Response rate defined as the percentage of patients with a >50% reduction from baseline in the MADRS total score at final assessment
  • Time Frame: Enrolment Day, Days 1, 8, 15, 22, 29, 36, 43, 50, 56
    Safety Issue?: No
• The change in the MADRS total score from baseline in each assessment
  • Time Frame: Enrolment Day, Days 1, 8, 15, 22, 29, 36, 43, 50, 56
    Safety Issue?: No
• To evaluate the safety and tolerability by comparing the incidence of treatment-emergent mania defined as the percentage of patients in each group who had a YMRS total score of 16 or greater on any 2 consecutive visits
  • Time Frame: Enrolment, washout and treatment period
    Safety Issue?: Yes

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 enrolment. 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Simavi Vahip, Prof. Dr. Principal Investigator Ege University Faculty of Medicine Psychiatry Department İzmir  

Overall Contact: AstraZeneca Turkey Clinical Study Information 00 90 212 317 23 00 zeynep.goztas@astrazeneca.com

Information obtained from ClinicalTrials.gov on February 04, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00883493

Study ID Number: D1443L00055

ClinicalTrials.gov Identifier: NCT00883493

Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica