Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression

Condition(s) targeted: Acute Bipolar Depression

Intervention: Quetiapine fumarate XR (Drug); Lithium carbonate (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Simavi Vahip, Prof. Dr., Principal Investigator, Affiliation: Ege University Faculty of Medicine Psychiatry Department İzmir

Overall contact:
AstraZeneca Turkey Clinical Study Information, Phone: 00 90 212 317 23 00, Email: zeynep.goztas@astrazeneca.com

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.

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

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

Primary outcome: The primary outcome variable of the study is the change from baseline in the MADRS total score to Day 56.

Secondary outcome:

Response rate defined as the percentage of patients with a >50% reduction from baseline in the MADRS total score at final assessment

The change in the MADRS total score from baseline in each assessment

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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.

AstraZeneca Turkey Clinical Study Information, Phone: 00 90 212 317 23 00, Email: zeynep.goztas@astrazeneca.com

Research Site, CABA, Argentina; Not yet recruiting

Research Site, LA PLATA, Argentina; Not yet recruiting

Research Site, MENDOZA, Argentina; Not yet recruiting

Research Site, RIO DE JANEIRO, Brazil; Not yet recruiting

Research Site, SANTIAGO, Chile; Not yet recruiting

Research Site, DURANGO, Mexico; Not yet recruiting

Research Site, YUCATAN, Mexico; Not yet recruiting

Research Site, SAN LUIS POTOSI, Mexico; Not yet recruiting

Research Site, LIMA, Peru; Not yet recruiting

Research Site, ANKARA, Turkey; Recruiting

Research Site, ELAZIG, Turkey; Recruiting

Research Site, ISTANBUL, Turkey; Recruiting

Research Site, IZMIR, Turkey; Not yet recruiting

Research Site, KOCAELI, Turkey; Not yet recruiting

Research Site, MALATYA, Turkey; Not yet recruiting

Research Site, MANISA, Turkey; Recruiting

Research Site, CARACAS, Venezuela; Not yet recruiting

Research Site, MEDELLIN, ANTIOQUIA, Colombia; Not yet recruiting

Research Site, GUATEMALA, Ciudad De Guatemala, Guatemala; Not yet recruiting

Research Site, BOGOT� D.C, Cundinamarca, Colombia; Not yet recruiting

Research Site, MEXICO, D.F., Mexico; Not yet recruiting

Research Site, GODOY CRUZ, MENDOZA, Argentina; Not yet recruiting

Research Site, MONTERREY, NUEVO LEON, Mexico; Not yet recruiting

Research Site, SAO PAULO, SP, Brazil; Not yet recruiting

Research Site, MERIDA, YUCATAN, Mexico; Not yet recruiting

Starting date: April 2009
Ending date: August 2010
Last updated: July 30, 2009