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

Sponsored by:	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

MedlinePlus related topics: Depression

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

U.S. FDA Resources

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

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 ]

Estimated Enrollment:	412
Study Start Date:	April 2009
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Quetiapin fumarate XR: Experimental 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.
Quetiapin fumarate XR+Lithium carbonate: Experimental 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. 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

Assigned Interventions

Quetiapin fumarate XR: Experimental

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.

Quetiapin fumarate XR+Lithium carbonate: Experimental

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.

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

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 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.

Contacts and Locations

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

Contacts

Contact: AstraZeneca Turkey Clinical Study Information

00 90 212 317 23 00

zeynep.goztas@astrazeneca.com

Show 27 Study Locations

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:	AstraZeneca ( MC MD )
Study ID Numbers:	D1443L00055
Study First Received:	April 16, 2009
Last Updated:	April 17, 2009
ClinicalTrials.gov Identifier:	NCT00883493 History of Changes
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

Study placed in the following topic categories:

Tranquilizing Agents
Depression
Bipolar Disorder
Psychotropic Drugs
Central Nervous System Depressants
Lithium Carbonate
Antipsychotic Agents
Antimanic Agents
Depressive Disorder

Behavioral Symptoms
Affective Disorders, Psychotic
Quetiapine
Mental Disorders
Mood Disorders
Psychotic Disorders
Lithium
Antidepressive Agents

Additional relevant MeSH terms:

Tranquilizing Agents
Depression
Molecular Mechanisms of Pharmacological Action
Bipolar Disorder
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Lithium Carbonate
Enzyme Inhibitors
Antipsychotic Agents
Antimanic Agents

Depressive Disorder
Pharmacologic Actions
Behavioral Symptoms
Affective Disorders, Psychotic
Quetiapine
Mental Disorders
Therapeutic Uses
Mood Disorders
Central Nervous System Agents
Lithium
Antidepressive Agents

ClinicalTrials.gov processed this record on May 06, 2009