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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Bipolar Depression

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

Phase: Phase 3

Status: Completed

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


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.

Clinical Details

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.

Secondary outcome:

Response Rate for MADRS.

Hamilton Rating Scale for Depression (HAM-D) Total Score.

Change in Hamilton Rating Scale for Anxiety (HAM-A) Total Score

Change in the Clinical Global Impression Severity (CGI-S) Score.

Change in Young Mania Rating Scale (YMRS) Total Score.

Change in the Pittsburgh Sleep Quality Index (PSQI)Total Score.

Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Score.

Change in the Sheehan Disability Scale (SDS) Total Score.

Treatment Satisfaction Questionnaire (TSQ) Scores.


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


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

Locations and Contacts

Research Site, Caba, Argentina

Research Site, Mendoza, Argentina

Research Site, Rio de Janeiro, Brazil

Research Site, Santiago, Chile

Research Site, Durango, Mexico

Research Site, Monterrey, Mexico

Research Site, San Luis Potosi, Mexico

Research Site, Lima, Peru

Research Site, Ankara, Turkey

Research Site, Elazig, Turkey

Research Site, Istanbul, Turkey

Research Site, Izmir, Turkey

Research Site, Kocaeli, Turkey

Research Site, Malatya, Turkey

Research Site, Manisa, Turkey

Research Site, Caracas, Venezuela

Research Site, Medellin, Antioquia, Colombia

Research Site, La Plata, Buenos Aires, Argentina

Research Site, Guatemala, Ciudad de Guatemala, Guatemala

Research Site, Bogota D.c, Cundinamarca, Colombia

Research Site, Aparecida de Goiania, GO, Brazil

Research Site, Godoy Cruz, Mendoza, Argentina

Research Site, Monterrey, Nuevo Leon, Mexico

Research Site, Sao Paulo, SP, Brazil

Additional Information

Starting date: April 2009
Last updated: July 2, 2012

Page last updated: August 23, 2015

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