NCT00883493

Brief Summary

The purpose of this study is to compare the efficacy of quetiapine fumarate monotherapy with quetiapine fumarate in combination with lithium in the treatment of a major depressive episode in patients with bipolar disorder.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
421

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2009

Geographic Reach
9 countries

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 17, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 29, 2012

Completed
Last Updated

July 11, 2012

Status Verified

July 1, 2012

Enrollment Period

1.9 years

First QC Date

April 16, 2009

Results QC Date

February 29, 2012

Last Update Submit

July 2, 2012

Conditions

Acute Bipolar Depression

Keywords

Acute bipolar depressionLithium carbonatequetiapine fumarateMADRS

Outcome Measures

Primary Outcomes (1)

  • Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.

    The change of MADRS Total Score from baseline to the end of treatment was calculated by subtracting the MADRS Total Score assessed at week 8 from the baseline one (Baseline - 8 weeks). The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.

    Baseline, 8 weeks

Secondary Outcomes (9)

  • Response Rate for MADRS.

    baseline, week 8

  • Hamilton Rating Scale for Depression (HAM-D) Total Score.

    Baseline, 8 Weeks

  • Change in Hamilton Rating Scale for Anxiety (HAM-A) Total Score

    baseline, 8 weeks

  • Change in the Clinical Global Impression Severity (CGI-S) Score.

    baseline, 8 weeks

  • Change in Young Mania Rating Scale (YMRS) Total Score.

    baseline, 8 weeks

  • +4 more secondary outcomes

Study Arms (2)

Quetiapin fumarate XR

EXPERIMENTAL

Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.

Drug: Quetiapine fumarate XR

Quetiapin fumarate XR+Lithium carbonate

EXPERIMENTAL

Quetiapine XR will be administered like monotherapy arm. Lithium will be administered twice daily from Day 1 to Day 56.

Drug: Quetiapine fumarate XRDrug: Lithium carbonate

Interventions

Quetiapine fumarate XRDRUG

Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.

Also known as: SEROQUEL XR
Quetiapin fumarate XRQuetiapin fumarate XR+Lithium carbonate
Lithium carbonateDRUG

Twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose of lithium could be increased gradually within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose could be adjusted from 600 to 1800 mg/day

Also known as: LITHURIL Tb in TURKEY, LITOCARB in PERU
Quetiapin fumarate XR+Lithium carbonate

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Outpatients that meet the diagnostic criteria for bipolar disorder I and bipolar disorder II with the most recent episode depressed
  • The total score of the scale that's used for the evaluation of depression (HAM-D) should be ≥20
  • The total score of the scale that' used for the evaluation of mania (YMRS) should be ≤12

You may not qualify if:

  • Patients with a current DSM-IV-TR Axis I disorder other than bipolar disorder within 6 months of enrollment. Patients who pose a current serious suicidal or homicidal risk
  • Use of drugs that induce or inhibit the hepatic metabolizing enzymes within 14 days before randomisation
  • Patients who are unable to discontinue all psychoactive medications, including antidepressants, antipsychotics, and mood stabilizers at least 7 days prior to randomisation and consistent with the pharmacokinetics of the drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Research Site

La Plata, Buenos Aires, Argentina

Location

Research Site

Godoy Cruz, Mendoza Province, Argentina

Location

Research Site

Mendoza, Mendoza Province, Argentina

Location

Research Site

Caba, Argentina

Location

Research Site

Aparecida de Goiânia, Goiás, Brazil

Location

Research Site

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Research Site

São Paulo, São Paulo, Brazil

Location

Research Site

Santiago, Chile, Chile

Location

Research Site

Medellín, Antioquia, Colombia

Location

Research Site

Bogota D.c, Cundinamarca, Colombia

Location

Research Site

Guatemala City, Ciudad de Guatemala, Guatemala

Location

Research Site

Monterrey, Nuevo León, Mexico

Location

Research Site

San Luis Potosí City, San Luis Potosí, Mexico

Location

Research Site

Durango, Mexico

Location

Research Site

Monterrey, Mexico

Location

Research Site

Lima, Lima Province, Peru

Location

Research Site

Ankara, Turkey, Turkey (Türkiye)

Location

Research Site

Elâzığ, Turkey, Turkey (Türkiye)

Location

Research Site

Istanbul, Turkey, Turkey (Türkiye)

Location

Research Site

Izmir, Turkey, Turkey (Türkiye)

Location

Research Site

Kocaeli, Turkey, Turkey (Türkiye)

Location

Research Site

Malatya, Turkey, Turkey (Türkiye)

Location

Research Site

Manisa, Turkey, Turkey (Türkiye)

Location

Research Site

Caracas, Venezuela

Location

MeSH Terms

Interventions

Lithium Carbonate

Intervention Hierarchy (Ancestors)

CarbonatesAlkaliesInorganic ChemicalsCarbonic AcidCarbon Compounds, InorganicLithium Compounds

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com

Study Officials

  • Simavi Vahip, Prof. Dr.

    Ege University Faculty of Medicine Psychiatry Department İzmir

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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

April 16, 2009

First Posted

April 17, 2009

Study Start

April 1, 2009

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

July 11, 2012

Results First Posted

June 29, 2012

Record last verified: 2012-07

Locations

GU(1)PE(1)CL(1)AR(4)TU(7)BR(3)CO(2)VE(1)ME(4)