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

April 16, 2012 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Cantabria
      • Santander, Cantabria, Spain
        • Research Site
    • Castilla-León
      • Zamora, Castilla-León, Spain
        • Research Site
    • Galicia
      • Vigo, Galicia, Spain
        • Research Site
    • Pais Vasco
      • Vitoria, Pais Vasco, Spain
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Quetiapine Extended Release
Lithium or valproate at stable doses within seric therapeutic levels
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 Names:
  • SEROQUEL XR®
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).
Active Comparator: Sertraline
Lithium or valproate at stable doses within seric therapeutic levels
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).
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 Names:
  • Zoloft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
baseline, week 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
baseline, week 1
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)
baseline, week 4
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)
baseline. week 8
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)
baseline, week 1
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)
baseline, week 2
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)
baseline, week 4
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)
baseline, week 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)
baseline, week 4
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)
baseline, week 8
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.
week 1
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.
week 2
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.
week 4
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.
week 8
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.
week 1
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.
week 2
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.
week 4
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.
week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

March 5, 2009

First Submitted That Met QC Criteria

March 5, 2009

First Posted (Estimate)

March 6, 2009

Study Record Updates

Last Update Posted (Estimate)

April 18, 2012

Last Update Submitted That Met QC Criteria

April 16, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1443L00058

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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