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Completed

NCT Number: NCT00857584

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

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.

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Key information

Conditions

Bipolar Disorder Bipolar Depression Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Vitoria-Gasteiz, Basque Country, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extended release quetiapine (quetiapine XR)

Drug

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 names: SEROQUEL XR®

Sertraline

Drug

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 names: Zoloft

adequate mood stabilizer

Drug

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).

Primary outcomes

  1. The Mean Change From Baseline to Week 2 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score

    Time frame: baseline, 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)

Secondary outcomes

  1. The Mean Change From Baseline to Week 1 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score

    Time frame: baseline, 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)

  2. The Mean Change From Baseline to Week 4 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score

    Time frame: baseline, 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)

  3. The Mean Change From Baseline to Week 8 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score

    Time frame: baseline. 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)

  4. 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

    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)

  5. 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

    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)

  6. 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

    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)

  7. 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

    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)

  8. The Mean Change From Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HARS) Total Score

    Time frame: baseline, week 4

    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)

  9. The Mean Change From Baseline to Week 8 in the Hamilton Anxiety Rating Scale (HARS) Total Score

    Time frame: baseline, week 8

    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)

  10. Number of Patients Response at Week 1

    Time frame: 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.

  11. Number of Patients With Response at Week 2

    Time frame: 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.

  12. Number of Patients With Response at Week 4.

    Time frame: 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.

  13. Number of Patients With Response at Week 8.

    Time frame: 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.

  14. Number of Patients With Remission at Week 1.

    Time frame: 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.

  15. Number of Patients With Remission at Week 2.

    Time frame: 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.

  16. Number of Patients With Remission at Week 4.

    Time frame: 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.

  17. Number of Patients With Remission at Week 8.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 6, 2009
Registry last updated
Apr 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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