Quetiapine XR vs Sertraline in Acute Bipolar Depression as add-on Therapy - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00857584

Purpose

Prospective, open-label, controlled (active comparator), randomized study of 8 weeks follow-up for the evaluation of the efficacy of Quetiapine XR vs. Sertraline in addition to previous mood stabilizer treatment (lithium or valproate at stable and clinically therapeutic blood levels) in the treatment of the adult bipolar depression. This multicentric study will be featured in two sites in Spain.

Condition	Intervention	Phase
Bipolar Disorder Bipolar Depression	Drug: Quetiapine XR Drug: sertraline	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Effectiveness of Quetiapine XR vs Sertraline in Acute Depression as add-on Therapy to Previous Mood Stabilizer Treatment: a Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder Depression

Drug Information available for: Sertraline hydrochloride Sertraline Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Change from baseline in the Montgomery Asberg Depression Rating Scale (MDRAS) global score at week 2 (V3, LOCF) endpoint in each treatment group. [ Time Frame: Week 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in the Montgomery Asberg Depression Rating Scale (MADRS) and in the Young Mania rating Scale (YMRS) global score from baseline to each assessment (LOCF) endpoint in each treatment group. [ Time Frame: Every patient visit (week 1, week 2, week 4 and week 8) ] [ Designated as safety issue: No ]
Response rate, defined as % of patients with a reduction of MADRS global score =50% from baseline, in each assessment (LOCF) for each treatment group. [ Time Frame: Every patient visit (week 1, week 2, week 4 and week 8) ] [ Designated as safety issue: No ]
Change in the CGI-BP-M depression subscale and general scale score from baseline in each assessment (LOCF) for each treatment group. [ Time Frame: Every patient visit (week 1, week 2, week 4 and week 8) ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	May 2009
Estimated Study Completion Date:	June 2010

Arms	Assigned Interventions
1: Experimental Lithium or valproate at stable doses within seric therapeutic levels	Drug: Quetiapine XR Flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length
2: Active Comparator Lithium or valproate at stable doses within seric therapeutic levels	Drug: sertraline Flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length

Eligibility

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

Criteria

Inclusion Criteria:

Adult ambulatory patients diagnosed of bipolar disorder I or II, current depressive episode (DSM-IV-TR 4ª Ed: 296.5x or 296.89 codes)
Have been treated with only one mood stabilizer (lithium or valproate) in optimal and stable doses during at least the previous 4 weeks to randomization.
HDRS-17 global score=20 or above and YMRS =14 or above at the screening and randomisation visits.
Informed consent signed

Exclusion Criteria:

Patients with any axis I or II DSM-IV-TR diagnoses different from bipolar disorder I or II
Length of current depressive episode less than 2 weeks or more than 12 months.
Having been treated with more than one mood stabilizer or any mood stabilizer other than Lithium or valproate, any antidepressant, any antipsychotic or any CP450-3A inductor/inhibitor within the 7 days period prior to randomization

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857584

Contacts

Contact: AstraZeneca Spain Clinical Study Information	+34 660 100 659	Esther.Prieto@astrazeneca.com
Contact: Eva Soriano Miguel	+ 34 91 334 81 05	Eva.soriano@astrazeneca.com

Locations

Spain, Cantabria
Research Site	Recruiting
Santander, Cantabria, Spain
Spain, Castilla-León
Research Site	Not yet recruiting
Zamora, Castilla-León, Spain
Spain, Galicia
Research Site	Recruiting
Vigo, Galicia, Spain
Spain, Pais Vasco
Research Site	Recruiting
Vitoria, Pais Vasco, Spain

Sponsors and Collaborators

AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( D. Teresa Díez, Medical Science Director )
Study ID Numbers:	D1443L00058
Study First Received:	March 5, 2009
Last Updated:	December 20, 2009
ClinicalTrials.gov Identifier:	NCT00857584 History of Changes
Health Authority:	Spain: Comité Ético de Investigación Clínica; Spain: Spanish Agency of Medicines

Keywords provided by AstraZeneca:

Bipolar disorder
Bipolar depression
quetiapine
sertraline

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Affective Disorders, Psychotic
Pathologic Processes
Mental Disorders
Therapeutic Uses
Sertraline
Antidepressive Agents
Disease
Depression

Tranquilizing Agents
Bipolar Disorder
Central Nervous System Depressants
Depressive Disorder
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Behavioral Symptoms
Quetiapine
Serotonin Agents
Mood Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010