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A Comparison of the Effectiveness of Seroquel XR and Seroquel XR Plus Lithium in Patients With Acute Bipolar Mania: An Open-label, Randomized, Parallel Groups, Rater-blinded, 4 Week, Multicenter, Comparative,Study (STAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01254721
Recruitment Status : Terminated (Difficulty of recruitment.)
First Posted : December 7, 2010
Results First Posted : May 8, 2014
Last Update Posted : May 8, 2014
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 Bipolar Mania
Interventions Drug: Quetiapine fumarate
Drug: lithium
Enrollment 131
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Seroquel XR Seroquel XR + Lithium
Hide Arm/Group Description

Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.

Treatment duration: 28 days

Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].

Treatment duration: 28 days

Period Title: Overall Study
Started 67 [1] 64 [2]
Completed 52 42
Not Completed 15 22
Reason Not Completed
Lost to Follow-up             0             4
Lack of Efficacy             4             2
Death             0             1
technical problum             1             0
Adverse Event             2             3
Withdrawal by Subject             8             11
Wrongly randomization             0             1
[1]
Seroquel XR: 300mg
[2]
Seroquel XR: 300mg Lithium: 900mg
Arm/Group Title Seroquel XR Seroquel XR + Lithium Total
Hide Arm/Group Description

Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.

Treatment duration: 28 days

Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].

Treatment duration: 28 days

Total of all reporting groups
Overall Number of Baseline Participants 63 58 121
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Age Number Analyzed 63 participants 58 participants 121 participants
38.4  (9.8) 36.9  (11.7) 37.7  (10.7)
[1]
Measure Description: Age in ITT population.
Age, Customized   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Age at onset of acute bipolar mania Number Analyzed 63 participants 58 participants 121 participants
31.0  (10.6) 30.0  (11.3) 30.5  (10.9)
[1]
Measure Description: Age at onset of acute bipolar mania in ITT analysis set
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 58 participants 121 participants
Female
37
  58.7%
34
  58.6%
71
  58.7%
Male
26
  41.3%
24
  41.4%
50
  41.3%
[1]
Measure Description: Total ITT analysis set is 121
Total No. of acute bipolar mania episodes over lifetime  
Mean (Standard Deviation)
Unit of measure:  Episodes
Number Analyzed 63 participants 58 participants 121 participants
4.24  (4.31) 3.25  (2.42) 3.76  (3.54)
Bipolar I Disorder   [1] 
Measure Type: Number
Unit of measure:  Number of Patients in ITT analysis set
Number Analyzed 63 participants 58 participants 121 participants
Manic Episodes 57 51 108
Mixed Episodes 6 7 13
[1]
Measure Description: number of patients experiencing manic and mixed episodes in ITT analysis set
1.Primary Outcome
Title The Changes From Baseline in Young Mania Rating Scale (YMRS) Total Score to Day 29
Hide Description The Young Mania Rating Scale (YMRS) is an eleven-item, multiple-choice diagnostic questionnaire which psychiatrists use to measure the severity of manic episodes. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. Total score is summed of 11items. Total score rage is from 0 to 60 and the higher score represent a worse oucome.
Time Frame From Baseline to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Seroquel XR Seroquel XR + Lithium
Hide Arm/Group Description:

Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.

Treatment duration: 28 days

Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].

Treatment duration: 28 days

Overall Number of Participants Analyzed 63 58
Mean (Standard Deviation)
Unit of Measure: scores on the scale
-13.7  (13.8) -15.5  (13.3)
2.Secondary Outcome
Title The Change From Baseline up to Day 29 and Final Assessment in the Clinical Global Impression-Severity of Illness Scale (CGI-S)
Hide Description The Severity of Illness scale (CGI-S) is scored to rate the patient's current clinical state. The score range is form 0 to 7. A CGI-S score of 1 indicates that a patient is "Normal, not at all ill" and a score of 7 indicates that a patient is "Among the most extremely ill patients".
Time Frame From Baseline to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Seroquel XR Seroquel XR + Lithium
Hide Arm/Group Description:

Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.

Treatment duration: 28 days

Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].

Treatment duration: 28 days

Overall Number of Participants Analyzed 63 58
Mean (Standard Deviation)
Unit of Measure: scores on the scale
-1.37  (1.52) -1.58  (1.56)
Time Frame Day1 to Day29
Adverse Event Reporting Description Safety set number is 130 (Seroquel XR 68 and Seroquel XR+Lithium 62)
 
Arm/Group Title Seroquel XR Seroquel XR + Lithium
Hide Arm/Group Description

Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.

Treatment duration: 28 days

Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].

Treatment duration: 28 days

All-Cause Mortality
Seroquel XR Seroquel XR + Lithium
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Seroquel XR Seroquel XR + Lithium
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/68 (2.94%)      2/62 (3.23%)    
Psychiatric disorders     
MANIC SYMPTOMS AGGRAVATION   0/68 (0.00%)  0 1/62 (1.61%)  1
BIPOLAR MANIA   1/68 (1.47%)  1 0/62 (0.00%)  0
MOOD ELEVATION   1/68 (1.47%)  1 0/62 (0.00%)  0
DEATH   0/68 (0.00%)  0 1/62 (1.61%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Seroquel XR Seroquel XR + Lithium
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   52/68 (76.47%)      49/62 (79.03%)    
Gastrointestinal disorders     
Dyspepsia   8/68 (11.76%)  9 3/62 (4.84%)  4
Dry mouth   3/68 (4.41%)  4 7/62 (11.29%)  7
Constipation   20/68 (29.41%)  21 20/62 (32.26%)  21
Infections and infestations     
Nasopharyngitis   5/68 (7.35%)  6 5/62 (8.06%)  5
Nervous system disorders     
Headache   6/68 (8.82%)  6 6/62 (9.68%)  10
Akathisia   4/68 (5.88%)  4 5/62 (8.06%)  5
Tremor   3/68 (4.41%)  3 6/62 (9.68%)  6
Dizziness   6/68 (8.82%)  6 2/62 (3.23%)  2
Psychiatric disorders     
Insomnia   8/68 (11.76%)  8 2/62 (3.23%)  2
Indicates events were collected by systematic assessment
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: Hui Jung Sin / Clinical Project Leader
Organization: SM&M Korea
Phone: 82-2-2188-2165
EMail: ClinicalTrialTransparency@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01254721    
Other Study ID Numbers: D1443L00086
First Submitted: December 3, 2010
First Posted: December 7, 2010
Results First Submitted: October 22, 2013
Results First Posted: May 8, 2014
Last Update Posted: May 8, 2014