Quetiapine XR Versus Sertraline in Acute Bipolar Depression as add-on Therapy

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00857584

First received: March 5, 2009

Last updated: April 16, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 5, 2009
Last Updated Date	April 16, 2012
Start Date ^ICMJE	May 2009
Primary Completion Date	February 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 15, 2012)	The Mean Change From Baseline to Week 2 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: baseline, week 2 ] [ Designated as safety issue: No ] MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms)
Original Primary Outcome Measures ^ICMJE (submitted: March 5, 2009)	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 ]
Change History	Complete list of historical versions of study NCT00857584 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 16, 2012)	The Mean Change From Baseline to Week 1 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: baseline, week 1 ] [ Designated as safety issue: No ] MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms) The Mean Change From Baseline to Week 4 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: baseline, week 4 ] [ Designated as safety issue: No ] MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms) The Mean Change From Baseline to Week 8 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: baseline. week 8 ] [ Designated as safety issue: No ] MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms) The Mean Change From Baseline to Week 1 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score [ Time Frame: baseline, week 1 ] [ Designated as safety issue: No ] CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity) The Mean Change From Baseline to Week 2 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score [ Time Frame: baseline, week 2 ] [ Designated as safety issue: No ] CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity) The Mean Change From Baseline to Week 4 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score [ Time Frame: baseline, week 4 ] [ Designated as safety issue: No ] CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity) The Mean Change From Baseline to Week 8 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score [ Time Frame: baseline, week 8 ] [ Designated as safety issue: No ] CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 (higher scores indicating a greater clinical severity) The Mean Change From Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HARS) Total Score [ Time Frame: baseline, week 4 ] [ Designated as safety issue: No ] HARS assesses severity of anxiety symptoms. It ranges from a minimum of 0 to a maximum of 56 (higher scores indicating a greater severity of anxiety symptoms) The Mean Change From Baseline to Week 8 in the Hamilton Anxiety Rating Scale (HARS) Total Score [ Time Frame: baseline, week 8 ] [ Designated as safety issue: No ] HARS assesses severity of anxiety symptoms. It ranges from a minimum of 0 to a maximum of 56 (higher scores indicating a greater severity of anxiety symptoms) Number of Patients Response at Week 1 [ Time Frame: week 1 ] [ Designated as safety issue: No ] Number of patients responded to the treatment at week 1, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 1. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms. Number of Patients With Response at Week 2 [ Time Frame: week 2 ] [ Designated as safety issue: No ] Number of patients responded to the treatment at week 2, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 2. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms. Number of Patients With Response at Week 4. [ Time Frame: week 4 ] [ Designated as safety issue: No ] Number of patients responded to the treatment at week 4, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 4. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms. Number of Patients With Response at Week 8. [ Time Frame: week 8 ] [ Designated as safety issue: No ] Number of patients responded to the treatment at week 8, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 8. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms. Number of Patients With Remission at Week 1. [ Time Frame: week 1 ] [ Designated as safety issue: No ] Number of patients who achieved remission at week 1, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms. Number of Patients With Remission at Week 2. [ Time Frame: week 2 ] [ Designated as safety issue: No ] Number of patients who achieved remission at week 2, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms. Number of Patients With Remission at Week 4. [ Time Frame: week 4 ] [ Designated as safety issue: No ] Number of patients who achieved remission at week 4, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms. Number of Patients With Remission at Week 8. [ Time Frame: week 8 ] [ Designated as safety issue: No ] Number of patients who achieved remission at week 8, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms.
Original Secondary Outcome Measures ^ICMJE (submitted: March 5, 2009)	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 ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Quetiapine XR Versus Sertraline in Acute Bipolar Depression as add-on Therapy
Official Title ^ICMJE	Effectiveness of Quetiapine XR Versus Sertraline in Acute Depression as add-on Therapy to Previous Mood Stabilizer Treatment: a Pilot Study
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Bipolar Disorder Bipolar Depression
Intervention ^ICMJE	Drug: Extended release quetiapine (quetiapine XR) Flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length. Quetiapine XR was initiated at 50 mg/day and titrated to 100 mg on day 2, 200 mg on day 3, 300 mg on day 4, and flexible doses of 300 to 600 mg/d from day 5 to the end of the study. Other Name: SEROQUEL XR® Drug: Sertraline Flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length. Sertraline titration: 50 mg on day 1-3, 100 mg on day 4, and flexible doses of 50 to 200 mg/d from day 5 to the end of the study. Other Name: Zoloft Drug: adequate mood stabilizer An adequate mood stabilizer treatment with lithium or valproate(defined as a serum concentration of 0.5-1.2 mEq/L or 50-100 microg/ml, respectively).
Study Arm (s)	Experimental: Quetiapine Extended Release Lithium or valproate at stable doses within seric therapeutic levels Interventions: Drug: Extended release quetiapine (quetiapine XR) Drug: adequate mood stabilizer Active Comparator: Sertraline Lithium or valproate at stable doses within seric therapeutic levels Interventions: Drug: Sertraline Drug: adequate mood stabilizer
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	27
Completion Date	February 2011
Primary Completion Date	February 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Spain

Administrative Information
NCT Number ^ICMJE	NCT00857584
Other Study ID Numbers ^ICMJE	D1443L00058
Has Data Monitoring Committee	No
Responsible Party	AstraZeneca
Study Sponsor ^ICMJE	AstraZeneca
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	AstraZeneca
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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