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Trial record 93 of 450 for:    QUETIAPINE

Quetiapine Fumarate (Seroquel) as Mono-Therapy or Adjunct to Lithium in the Treatment of Patients With Acute Mania in Bipolar Disorder (MANIA)

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ClinicalTrials.gov Identifier: NCT00672490
Recruitment Status : Completed
First Posted : May 6, 2008
Results First Posted : July 12, 2012
Last Update Posted : July 12, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Mania in Bipolar Disorder
Interventions Drug: Quetiapine Fumarate
Drug: Lithium
Enrollment 376
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Quetiapine Fumarate Used as Mono-Therapy Quetiapine Fumarate Used as Adjunct Therapy
Hide Arm/Group Description Quetiapine Fumarate 600 to 800 mg/day Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
Period Title: Overall Study
Started 187 189
Completed 163 157
Not Completed 24 32
Reason Not Completed
Withdrawal by Subject             8             8
Lack of Compliance             2             7
Mismatch Include/Exclude Criteria             1             0
Adverse Event             5             8
Violation of Concomitant Medicine             1             0
Intolerance             0             2
Lost to Follow-up             1             5
No reason was provided             6             2
Arm/Group Title Quetiapine Fumarate Used as Mono-Therapy Quetiapine Fumarate Used as Adjunct Therapy Total
Hide Arm/Group Description Quetiapine Fumarate 600 to 800 mg/day Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day Total of all reporting groups
Overall Number of Baseline Participants 187 189 376
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 187 participants 189 participants 376 participants
34.3  (12.16) 32.43  (11.14) 33.36  (11.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 187 participants 189 participants 376 participants
Female
94
  50.3%
87
  46.0%
181
  48.1%
Male
93
  49.7%
102
  54.0%
195
  51.9%
1.Primary Outcome
Title Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 28)
Hide Description 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 and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population
Arm/Group Title Quetiapine Fumarate Used as Mono-Therapy Quetiapine Fumarate Used as Adjunct Therapy
Hide Arm/Group Description:
Quetiapine Fumarate 600 to 800 mg/day
Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
Overall Number of Participants Analyzed 178 178
Mean (Standard Deviation)
Unit of Measure: score on a scale
-25.7  (13.7) -26.1  (13.4)
2.Secondary Outcome
Title Change From Baseline in the Clinical Global Impressions for Bipolar Disorder Severity of Illness (CGI-BP-S) Score to Each Assessment (Day 28)
Hide Description The CGI-BP-S scale rates the severity of the patient's illness at the time of assessment and is scored from 1 to 7 (1=normal, not ill to 7=very severely ill). Higher CGI-BP-S scores indicate greater illness severity
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine Fumarate Used as Mono-Therapy Quetiapine Fumarate Used as Adjunct Therapy
Hide Arm/Group Description:
Quetiapine Fumarate 600 to 800 mg/day
Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
Overall Number of Participants Analyzed 187 189
Mean (Standard Deviation)
Unit of Measure: score on a scale
-2.65  (0.115) -0.17  (0.144)
3.Secondary Outcome
Title Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score to Each Assessment (Day 28)
Hide Description The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score is the sum of all 30 individual-item scores and ranges from 30 to 210
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine Fumarate Used as Mono-Therapy Quetiapine Fumarate Used as Adjunct Therapy
Hide Arm/Group Description:
Quetiapine Fumarate 600 to 800 mg/day
Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
Overall Number of Participants Analyzed 187 189
Mean (Standard Deviation)
Unit of Measure: units on a scale
-16.12  (0.285) -16.44  (0.28)
4.Secondary Outcome
Title Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score to Each Assessment(Day 28)
Hide Description The MADRS is a 10-item scale that evaluates depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. Higher MADRS scores indicate higher levels of depressive symptoms. The MADRS total score is the sum of all 10 individual-item scores and ranges from 0 to 60.
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine Fumarate Used as Mono-Therapy Quetiapine Fumarate Used as Adjunct Therapy
Hide Arm/Group Description:
Quetiapine Fumarate 600 to 800 mg/day
Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
Overall Number of Participants Analyzed 187 189
Mean (Standard Deviation)
Unit of Measure: score on a scale
-2.99  (0.181) -3.02  (0.179)
5.Secondary Outcome
Title Change From Baseline in the Young Mania Rating Scale (YMRS) Item 4 Score to Each Assessment
Hide Description The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 4 (sleep) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine Fumarate Used as Mono-Therapy Quetiapine Fumarate Used as Adjunct Therapy
Hide Arm/Group Description:
Quetiapine Fumarate 600 to 800 mg/day
Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
Overall Number of Participants Analyzed 187 189
Mean (Standard Deviation)
Unit of Measure: score on a scale
-2.0  (1.2) -2.1  (1.2)
6.Secondary Outcome
Title Response Rate (Number of Patients With Clinically Response)
Hide Description The number of patients with clinically response (defined as ≥50% reduction in the YMRS total score from baseline to Day 28) was calculated. The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or 50% reduction) from baseline indicates a reduction (or improvement) in manic symptoms.
Time Frame From Baseline to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine Fumarate Used as Mono-Therapy Quetiapine Fumarate Used as Adjunct Therapy
Hide Arm/Group Description:
Quetiapine Fumarate 600 to 800 mg/day
Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
Overall Number of Participants Analyzed 187 189
Measure Type: Number
Unit of Measure: Participants
139 153
7.Secondary Outcome
Title Remission Rate (Number of Patients With Clinically Significant Remission)
Hide Description

The number of patients with clinically significant remission (defined as YMRS total score ≤12) at Day 28 was calculated.

The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania. Total score ≤12 indicates remission.

Time Frame From Baseline to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine Fumarate Used as Mono-Therapy Quetiapine Fumarate Used as Adjunct Therapy
Hide Arm/Group Description:
Quetiapine Fumarate 600 to 800 mg/day
Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
Overall Number of Participants Analyzed 187 189
Measure Type: Number
Unit of Measure: Participants
117 123
8.Secondary Outcome
Title Treatment of Agitation (Change From Baseline in the PANSS Activation Subscale Score to Day 28)
Hide Description The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS activation subscale score for effect on agitation and aggression is the sum of 6 PANSS individual items (ie, hostility, poor impulse control, excitement, uncooperativeness, poor rapport and tension) and ranges from 6 to 42.
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine Fumarate Used as Mono-Therapy Quetiapine Fumarate Used as Adjunct Therapy
Hide Arm/Group Description:
Quetiapine Fumarate 600 to 800 mg/day
Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
Overall Number of Participants Analyzed 187 189
Mean (Standard Deviation)
Unit of Measure: score on a scale
-5.4  (4.5) -5.8  (4.2)
9.Secondary Outcome
Title Treatment of Aggression Risk (Change From Baseline in the PANSS Supplement Aggression Risk Subscale Score to Day 28)
Hide Description The PANSS Supplemental Aggression Risk subscale score is the sum of 3 standard PANSS items – Excitement, Hostility and Depression – and 3 supplemental PANSS items related to anger – Anger, Difficulty in Delaying Gratification and Affective Lability and ranges from 6 to 42, where 6 is the "best" and 42 the "worst" score for the combined scale.
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine Fumarate Used as Mono-Therapy Quetiapine Fumarate Used as Adjunct Therapy
Hide Arm/Group Description:
Quetiapine Fumarate 600 to 800 mg/day
Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
Overall Number of Participants Analyzed 187 189
Mean (Standard Deviation)
Unit of Measure: score on a scale
-6.8  (5.1) -7.3  (5.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Quetiapine Fumarate Used as Mono-Therapy Quetiapine Fumarate Used as Adjunct Therapy
Hide Arm/Group Description Quetiapine Fumarate 600 to 800 mg/day Quetiapine Fumarate 600 to 800 mg/day + lithium 500 mg to 2000 mg/day
All-Cause Mortality
Quetiapine Fumarate Used as Mono-Therapy Quetiapine Fumarate Used as Adjunct Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Quetiapine Fumarate Used as Mono-Therapy Quetiapine Fumarate Used as Adjunct Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/187 (0.00%)   1/189 (0.53%) 
Musculoskeletal and connective tissue disorders     
Injury * 1  0/187 (0.00%)  1/189 (0.53%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Quetiapine Fumarate Used as Mono-Therapy Quetiapine Fumarate Used as Adjunct Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   120/187 (64.17%)   125/189 (66.14%) 
Cardiac disorders     
Tachycardia  11/187 (5.88%)  7/189 (3.70%) 
Palpitations  7/187 (3.74%)  4/189 (2.12%) 
Endocrine disorders     
Hypothyroidism  0/187 (0.00%)  8/189 (4.23%) 
Gastrointestinal disorders     
Constipation  13/187 (6.95%)  24/189 (12.70%) 
Nausea  4/187 (2.14%)  15/189 (7.94%) 
Vomiting  1/187 (0.53%)  10/189 (5.29%) 
Diarrhoea  3/187 (1.60%)  9/189 (4.76%) 
Dry mouth  3/187 (1.60%)  6/189 (3.17%) 
General disorders     
Fatigue  4/187 (2.14%)  6/189 (3.17%) 
Investigations     
Weight Increased  12/187 (6.42%)  16/189 (8.47%) 
Liver function test abnormal  8/187 (4.28%)  9/189 (4.76%) 
Metabolism and nutrition disorders     
Hyperlipidemia  3/187 (1.60%)  7/189 (3.70%) 
Nervous system disorders     
Dizziness  21/187 (11.23%)  14/189 (7.41%) 
Extrapyramidal Symptom  6/187 (3.21%)  12/189 (6.35%) 
Somnolence  10/187 (5.35%)  10/189 (5.29%) 
Tremor  5/187 (2.67%)  13/189 (6.88%) 
Hypersomnia  13/187 (6.95%)  9/189 (4.76%) 
Respiratory, thoracic and mediastinal disorders     
Upper respiratory tract infection  14/187 (7.49%)  12/189 (6.35%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gerard Lynch
Organization: AstraZeneca
EMail: aztrial_results_posting@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00672490     History of Changes
Other Study ID Numbers: D1443L00023
First Submitted: May 2, 2008
First Posted: May 6, 2008
Results First Submitted: June 24, 2010
Results First Posted: July 12, 2012
Last Update Posted: July 12, 2012