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| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
| 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 | |
More Information
| 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 |
|
Bipolar disorder Bipolar depression quetiapine sertraline |
|
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 |