Clinical trial NCT00857584: Quetiapine XR Versus Sertraline in Acute Bipolar Depression as add-on Therapy
Official title: Effectiveness of Quetiapine XR Versus Sertraline in Acute Depression as add-on Therapy to Previous Mood Stabilizer Treatment: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Bipolar Depression
Keywords: Bipolar disorder
Bipolar depression
quetiapine
sertraline
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-03-06
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, open-label, controlled (active comparator), randomized study of 8 weeks follow-up for the evaluation of the efficacy of extended release quetiapine (quetiapine XR) versus 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.


Eligibility 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
* Hamilton Depression Rating Scale (HDRS-17) total score ≥ 20 and Young Mania Rating Scale (YMRS) total score ≤ 14 at the screening and randomization visits - Informed consent signed

Exclusion Criteria:

* Patients with any axis I or II Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (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

Primary outcomes:
measure: The Mean Change From Baseline to Week 2 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: baseline, week 2
Secondary outcomes:
measure: The Mean Change From Baseline to Week 1 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: baseline, week 1
measure: The Mean Change From Baseline to Week 4 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: baseline, week 4
measure: The Mean Change From Baseline to Week 8 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: baseline. week 8
measure: The Mean Change From Baseline to Week 1 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score
timeFrame: baseline, week 1
measure: The Mean Change From Baseline to Week 2 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score
timeFrame: baseline, week 2
measure: The Mean Change From Baseline to Week 4 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score
timeFrame: baseline, week 4
measure: The Mean Change From Baseline to Week 8 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score
timeFrame: baseline, week 8
measure: The Mean Change From Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HARS) Total Score
timeFrame: baseline, week 4
measure: The Mean Change From Baseline to Week 8 in the Hamilton Anxiety Rating Scale (HARS) Total Score
timeFrame: baseline, week 8
measure: Number of Patients Response at Week 1
timeFrame: week 1
measure: Number of Patients With Response at Week 2
timeFrame: week 2
measure: Number of Patients With Response at Week 4.
timeFrame: week 4
measure: Number of Patients With Response at Week 8.
timeFrame: week 8
measure: Number of Patients With Remission at Week 1.
timeFrame: week 1
measure: Number of Patients With Remission at Week 2.
timeFrame: week 2
measure: Number of Patients With Remission at Week 4.
timeFrame: week 4
measure: Number of Patients With Remission at Week 8.
timeFrame: week 8
Other outcomes:
Locations:
city: Santander
country: Spain
facility: Research Site
state: Cantabria
city: Zamora
country: Spain
facility: Research Site
state: Castilla-León
city: Vigo
country: Spain
facility: Research Site
state: Galicia
city: Vitoria
country: Spain
facility: Research Site
state: Pais Vasco
Study officials:
References: