Back to resultsEfficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression (QUALITY)
Primary Purpose
Acute Bipolar Depression
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Quetiapine fumarate XR
Lithium carbonate
Sponsored by
About this trial
This is an interventional treatment trial for Acute Bipolar Depression focused on measuring Acute bipolar depression, Lithium carbonate, quetiapine fumarate, MADRS
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Quetiapin fumarate XR
Quetiapin fumarate XR+Lithium carbonate
Arm Description
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.
Quetiapine XR will be administered like monotherapy arm. Lithium will be administered twice daily from Day 1 to Day 56.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Response Rate for MADRS.
Response rate defined as the percentage of patients with a ≥50% reduction from baseline in the MADRS total score to the final assessment at week 8.
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.
Hamilton Rating Scale for Depression (HAM-D) Total Score.
The mean change of HAM-D Total Score from baseline to the end of treatment was calculated by subtracting the HAM-D Total Score assessed at week 8 from the baseline one (Baseline - week 8).
HAM-D is a multiple choice questionnaire used to rate the severity of a patient's major depression. It consists of 17 different items with possible scores from 0 to 4 or 0 to 2 or 0 to 6 depending on the items. Sum the total of all seventeen items gives the HAM-D Total Score, which may range from 0 (min) to 53 (max). The higher the score, the more severe the depression.
Change in Hamilton Rating Scale for Anxiety (HAM-A) Total Score
The mean change in HAM-A total score from baseline to final assessment was calculated by subtracting the HAM-A Total score assessed at week 8 from the total score assessed at the baseline (baseline - week 8).
The HAM-A is a 14-item scale that assesses anxiety symptoms of anxiety such as "anxious mood", "tension" or "fears". Each item is scored on a 5-point scale, ranging from 0=not present to 4=severe. Sum the scores from all 14 parameters gives the HAM-A Total Score which may range from 0 (min) to 56 (max).
Change in the Clinical Global Impression Severity (CGI-S) Score.
The reported mean change in the CGI-S score was calculated as baseline - week 8.
CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. A patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
Change in Young Mania Rating Scale (YMRS) Total Score.
The YMRS is a rating scale to assess manic symptoms. The scale has 11 items and is based upon patient's subjective report of his or hers clinical condition over the previous 48 hours.
The mean change in YMRS Total score reported was calculated as baseline - week 8.
The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania).
Change in the Pittsburgh Sleep Quality Index (PSQI)Total Score.
The mean change in PSQI score from baseline to final assessment at week 8 was calculated as baseline - week 8.
PSQI evaluates 7 areas of quality and pattern of sleep: sleep quality, duration getting to sleep, sleep duration, sleep adequacy, sleep disturbance, use of sleeping pill, and somnolence). Each area is rated on a scale from 0 (better) to 3 (worse) with a total score ranging from 0 to 21. Reduction in total scores are associated with better sleep quality.
Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Score.
The mean change in (Q-LES-Q-Short Form) Total Score from baseline to week 8 was calculated by subtracting the 8 week value from baseline value (baseline - week 8).
The Q-LES-Q-SF is a patient self assessment questionnaire consisting of 16 self-rated questions (1 being very poor - 5 very good); the first 14 will be incorporated into a total score. Higher scores indicate better quality of life.
Change in the Sheehan Disability Scale (SDS) Total Score.
The mean change in the SDS Total score from baseline to week 8 (baseline- week 8).
Sheehan Disability Scale is a 5 item scale, with a visual analog scale evaluating work/school work, social life and family life ranging from 0 to a maximum score of 30. Each one of the 3 domains is rated from 0-10 (no impairment to most severe impairment) with evaluation of not at all (0), mild (1-3), moderate (4-6), marked (7-9) and extreme (10) disability. A total score will be calculated. A score of 30 indicates most severe impairment.
Treatment Satisfaction Questionnaire (TSQ) Scores.
The 14-item TAQ questionnaire evaluates the patient's overall level of satisfaction with the study medication, the effectiveness, side effects and convenience of the medication.
Effectiveness, side effects, convenience and global satisfaction is rated on a scale of 0 being the worst and 100 being very effective, no side effects or very convenient or very satisfied. Overall satisfaction is rated over a score of 5 and 5 being the best overall satisfaction.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00883493
Brief Title
Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression
Acronym
QUALITY
Official Title
A Randomised, Multi-Centre Study to Compare the Efficacy and Safety of Extended Release Quetiapine Fumarate (Seroquel XR TM) Tablets as Mono-Therapy or in Combination With Lithium in the Treatment of Patients With Acute Bipolar Depression
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bipolar Depression
Keywords
Acute bipolar depression, Lithium carbonate, quetiapine fumarate, MADRS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
421 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Quetiapin fumarate XR
Arm Type
Experimental
Arm Description
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.
Arm Title
Quetiapin fumarate XR+Lithium carbonate
Arm Type
Experimental
Arm Description
Quetiapine XR will be administered like monotherapy arm. Lithium will be administered twice daily from Day 1 to Day 56.
Intervention Type
Drug
Intervention Name(s)
Quetiapine fumarate XR
Other Intervention Name(s)
SEROQUEL XR
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Lithium carbonate
Other Intervention Name(s)
LITHURIL Tb in TURKEY, LITOCARB in PERU
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.
Description
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.
Time Frame
Baseline, 8 weeks
Secondary Outcome Measure Information:
Title
Response Rate for MADRS.
Description
Response rate defined as the percentage of patients with a ≥50% reduction from baseline in the MADRS total score to the final assessment at week 8.
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.
Time Frame
baseline, week 8
Title
Hamilton Rating Scale for Depression (HAM-D) Total Score.
Description
The mean change of HAM-D Total Score from baseline to the end of treatment was calculated by subtracting the HAM-D Total Score assessed at week 8 from the baseline one (Baseline - week 8).
HAM-D is a multiple choice questionnaire used to rate the severity of a patient's major depression. It consists of 17 different items with possible scores from 0 to 4 or 0 to 2 or 0 to 6 depending on the items. Sum the total of all seventeen items gives the HAM-D Total Score, which may range from 0 (min) to 53 (max). The higher the score, the more severe the depression.
Time Frame
Baseline, 8 Weeks
Title
Change in Hamilton Rating Scale for Anxiety (HAM-A) Total Score
Description
The mean change in HAM-A total score from baseline to final assessment was calculated by subtracting the HAM-A Total score assessed at week 8 from the total score assessed at the baseline (baseline - week 8).
The HAM-A is a 14-item scale that assesses anxiety symptoms of anxiety such as "anxious mood", "tension" or "fears". Each item is scored on a 5-point scale, ranging from 0=not present to 4=severe. Sum the scores from all 14 parameters gives the HAM-A Total Score which may range from 0 (min) to 56 (max).
Time Frame
baseline, 8 weeks
Title
Change in the Clinical Global Impression Severity (CGI-S) Score.
Description
The reported mean change in the CGI-S score was calculated as baseline - week 8.
CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. A patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
Time Frame
baseline, 8 weeks
Title
Change in Young Mania Rating Scale (YMRS) Total Score.
Description
The YMRS is a rating scale to assess manic symptoms. The scale has 11 items and is based upon patient's subjective report of his or hers clinical condition over the previous 48 hours.
The mean change in YMRS Total score reported was calculated as baseline - week 8.
The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania).
Time Frame
baseline, 8 weeks
Title
Change in the Pittsburgh Sleep Quality Index (PSQI)Total Score.
Description
The mean change in PSQI score from baseline to final assessment at week 8 was calculated as baseline - week 8.
PSQI evaluates 7 areas of quality and pattern of sleep: sleep quality, duration getting to sleep, sleep duration, sleep adequacy, sleep disturbance, use of sleeping pill, and somnolence). Each area is rated on a scale from 0 (better) to 3 (worse) with a total score ranging from 0 to 21. Reduction in total scores are associated with better sleep quality.
Time Frame
Baseline, 8 weeks
Title
Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Score.
Description
The mean change in (Q-LES-Q-Short Form) Total Score from baseline to week 8 was calculated by subtracting the 8 week value from baseline value (baseline - week 8).
The Q-LES-Q-SF is a patient self assessment questionnaire consisting of 16 self-rated questions (1 being very poor - 5 very good); the first 14 will be incorporated into a total score. Higher scores indicate better quality of life.
Time Frame
baseline, 8 weeks
Title
Change in the Sheehan Disability Scale (SDS) Total Score.
Description
The mean change in the SDS Total score from baseline to week 8 (baseline- week 8).
Sheehan Disability Scale is a 5 item scale, with a visual analog scale evaluating work/school work, social life and family life ranging from 0 to a maximum score of 30. Each one of the 3 domains is rated from 0-10 (no impairment to most severe impairment) with evaluation of not at all (0), mild (1-3), moderate (4-6), marked (7-9) and extreme (10) disability. A total score will be calculated. A score of 30 indicates most severe impairment.
Time Frame
baseline, 8 weeks
Title
Treatment Satisfaction Questionnaire (TSQ) Scores.
Description
The 14-item TAQ questionnaire evaluates the patient's overall level of satisfaction with the study medication, the effectiveness, side effects and convenience of the medication.
Effectiveness, side effects, convenience and global satisfaction is rated on a scale of 0 being the worst and 100 being very effective, no side effects or very convenient or very satisfied. Overall satisfaction is rated over a score of 5 and 5 being the best overall satisfaction.
Time Frame
baseline, 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simavi Vahip, Prof. Dr.
Organizational Affiliation
Ege University Faculty of Medicine Psychiatry Department İzmir
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
La Plata
State/Province
Buenos Aires
Country
Argentina
Facility Name
Research Site
City
Godoy Cruz
State/Province
Mendoza
Country
Argentina
Facility Name
Research Site
City
Caba
Country
Argentina
Facility Name
Research Site
City
Mendoza
Country
Argentina
Facility Name
Research Site
City
Aparecida de Goiania
State/Province
GO
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
State/Province
SP
Country
Brazil
Facility Name
Research Site
City
Rio de Janeiro
Country
Brazil
Facility Name
Research Site
City
Santiago
Country
Chile
Facility Name
Research Site
City
Medellin
State/Province
Antioquia
Country
Colombia
Facility Name
Research Site
City
Bogota D.c
State/Province
Cundinamarca
Country
Colombia
Facility Name
Research Site
City
Guatemala
State/Province
Ciudad de Guatemala
Country
Guatemala
Facility Name
Research Site
City
Monterrey
State/Province
Nuevo Leon
Country
Mexico
Facility Name
Research Site
City
Durango
Country
Mexico
Facility Name
Research Site
City
Monterrey
Country
Mexico
Facility Name
Research Site
City
San Luis Potosi
Country
Mexico
Facility Name
Research Site
City
Lima
Country
Peru
Facility Name
Research Site
City
Ankara
Country
Turkey
Facility Name
Research Site
City
Elazig
Country
Turkey
Facility Name
Research Site
City
Istanbul
Country
Turkey
Facility Name
Research Site
City
Izmir
Country
Turkey
Facility Name
Research Site
City
Kocaeli
Country
Turkey
Facility Name
Research Site
City
Malatya
Country
Turkey
Facility Name
Research Site
City
Manisa
Country
Turkey
Facility Name
Research Site
City
Caracas
Country
Venezuela
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression
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