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

NCT00857584 | Completed Phase 3 Results

• 1 other identifier: D1443L00058
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 4

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.

Conditions

Bipolar Disorder; Bipolar Depression

Keywords

Bipolar disorder; Bipolar depression; quetiapine; sertraline

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (17)

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

  baseline, week 1

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

  baseline, week 4

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

  baseline. week 8

• The Mean Change From Baseline to Week 1 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score

  baseline, week 1

• The Mean Change From Baseline to Week 2 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score

  baseline, week 2

Study Arms (2)

Quetiapine Extended Release

EXPERIMENTAL

Lithium or valproate at stable doses within seric therapeutic levels

Drug: Extended release quetiapine (quetiapine XR); Drug: adequate mood stabilizer

Sertraline

ACTIVE COMPARATOR

Lithium or valproate at stable doses within seric therapeutic levels

Drug: Sertraline; Drug: adequate mood stabilizer

Interventions

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.

Also known as: SEROQUEL XR®

Quetiapine Extended Release

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.

Also known as: Zoloft

Sertraline

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).

Quetiapine Extended Release; Sertraline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (4)

Research Site

Vitoria-Gasteiz, Basque Country, Spain

Location

Research Site

Santander, Cantabria, Spain

Location

Research Site

Zamora, Castille and León, Spain

Location

Research Site

Vigo, Galicia, Spain

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2009
• First Posted: March 6, 2009
• Study Start: May 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: April 18, 2012
• Results First Posted: April 10, 2012

Record last verified: 2012-03

Locations

ES (4)