Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00883493

Purpose

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.

Condition	Intervention	Phase
Acute Bipolar Depression	Drug: Quetiapine fumarate XR Drug: Lithium carbonate	Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Quetiapine Quetiapine fumarate Lithium carbonate Lithium citrate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: Yes ]

Enrollment:	488
Study Start Date:	April 2009
Study Completion Date:	March 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	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. Other Name: SEROQUEL XR
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.	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. Other Name: SEROQUEL XR 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 Other Name: LITHURIL Tb in TURKEY

Arms

Assigned Interventions

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.

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.

Other Name: SEROQUEL XR

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.

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.

Other Name: SEROQUEL XR

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

Other Name: LITHURIL Tb in TURKEY

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00883493

Locations

Argentina
Research Site
La Plata, Buenos Aires, Argentina
Research Site
Godoy Cruz, Mendoza, Argentina
Research Site
Caba, Argentina
Research Site
Mendoza, Argentina
Brazil
Research Site
Aparecida de Goiania, GO, Brazil
Research Site
Sao Paulo, SP, Brazil
Research Site
Rio de Janeiro, Brazil
Chile
Research Site
Santiago, Chile
Colombia
Research Site
Medellin, Antioquia, Colombia
Research Site
Bogota D.c, Cundinamarca, Colombia
Guatemala
Research Site
Guatemala, Ciudad de Guatemala, Guatemala
Mexico
Research Site
Monterrey, Nuevo Leon, Mexico
Research Site
Durango, Mexico
Research Site
Monterrey, Mexico
Research Site
San Luis Potosi, Mexico
Peru
Research Site
Lima, Peru
Turkey
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
Venezuela
Research Site
Caracas, Venezuela

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Simavi Vahip, Prof. Dr.

Ege University Faculty of Medicine Psychiatry Department İzmir

More Information

No publications provided

Responsible Party:	MC MD, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00883493 History of Changes
Other Study ID Numbers:	D1443L00055
Study First Received:	April 16, 2009
Last Updated:	May 10, 2011
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Brazil: National Health Surveillance Agency; Chile: Instituto de Salud Publica de Chile; Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos; Guatemala: SUGEME (Independent Ethics Committe) y Comite de Farmacovigilancia; Mexico: National Institute of Public Health, Health Secretariat; Peru: General Directorate of Pharmaceuticals, Devices, and Drugs; Peru: Ministry of Health; Venezuela: Instituto Nacional de Higiene; Turkey: Ministry of Health

Keywords provided by AstraZeneca:

Acute bipolar depression
Lithium carbonate
quetiapine fumarate
MADRS

Additional relevant MeSH terms:

Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Lithium Carbonate
Lithium
Quetiapine
Antidepressive Agents

Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antipsychotic Agents

ClinicalTrials.gov processed this record on February 09, 2012