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

Bipolar Disorder Clinical Trial

Official title:

Effectiveness of Quetiapine XR Versus Sertraline in Acute Depression as add-on Therapy to Previous Mood Stabilizer Treatment: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00857584
• Other study ID #: D1443L00058
• Status: Completed
• Phase: Phase 3
• First received: March 5, 2009
• Last updated: April 16, 2012
• Start date: May 2009
• Est. completion date: February 2011

Study information

• Verified date: March 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación ClínicaSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

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.
• 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.
• 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).

Locations

Country	Name	City	State
Spain	Research Site	Santander	Cantabria
Spain	Research Site	Vigo	Galicia
Spain	Research Site	Vitoria	Pais Vasco
Spain	Research Site	Zamora	Castilla-León

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Mean Change From Baseline to Week 2 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score	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)	baseline, week 2	No
Secondary	The Mean Change From Baseline to Week 1 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score	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)	baseline, week 1	No
Secondary	The Mean Change From Baseline to Week 4 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score	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)	baseline, week 4	No
Secondary	The Mean Change From Baseline to Week 8 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score	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)	baseline. week 8	No
Secondary	The Mean Change From Baseline to Week 1 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score	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)	baseline, week 1	No
Secondary	The Mean Change From Baseline to Week 2 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score	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)	baseline, week 2	No
Secondary	The Mean Change From Baseline to Week 4 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score	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)	baseline, week 4	No
Secondary	The Mean Change From Baseline to Week 8 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score	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)	baseline, week 8	No
Secondary	The Mean Change From Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HARS) Total Score	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)	baseline, week 4	No
Secondary	The Mean Change From Baseline to Week 8 in the Hamilton Anxiety Rating Scale (HARS) Total Score	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)	baseline, week 8	No
Secondary	Number of Patients Response at Week 1	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.	week 1	No
Secondary	Number of Patients With Response at Week 2	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.	week 2	No
Secondary	Number of Patients With Response at Week 4.	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.	week 4	No
Secondary	Number of Patients With Response at Week 8.	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.	week 8	No
Secondary	Number of Patients With Remission at Week 1.	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.	week 1	No
Secondary	Number of Patients With Remission at Week 2.	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.	week 2	No
Secondary	Number of Patients With Remission at Week 4.	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.	week 4	No
Secondary	Number of Patients With Remission at Week 8.	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.	week 8	No