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Trial record 28 of 450 for:    QUETIAPINE

Gao Bipolar Spectrum Lithium/Quetiapine Study

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: NCT01526148
Recruitment Status : Terminated (Ran out of funding)
First Posted : February 3, 2012
Results First Posted : October 30, 2015
Last Update Posted : August 16, 2017
Sponsor:
Information provided by (Responsible Party):
Keming Gao, University Hospitals Cleveland Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Bipolar Disorder
Interventions Drug: Lithium
Drug: Quetiapine
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lithium Quetiapine
Hide Arm/Group Description Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L. Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
Period Title: Overall Study
Started 18 24
Completed 4 11
Not Completed 14 13
Reason Not Completed
Adverse Event             6             5
Lost to Follow-up             3             6
Withdrawal by Subject             2             0
Unstable Medical Condition             1             0
Unable to discontinue concomitant med             1             0
Moved out of state             1             0
Incarcerated             0             2
Arm/Group Title Lithium Quetiapine Total
Hide Arm/Group Description Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L. Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week. Total of all reporting groups
Overall Number of Baseline Participants 18 24 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 24 participants 42 participants
43.26  (16.66) 35.58  (12.64) 38.98  (14.88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 24 participants 42 participants
Female
11
  61.1%
10
  41.7%
21
  50.0%
Male
7
  38.9%
14
  58.3%
21
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 24 participants 42 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   5.6%
0
   0.0%
1
   2.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
  38.9%
15
  62.5%
22
  52.4%
White
10
  55.6%
9
  37.5%
19
  45.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants 24 participants 42 participants
Bipolar I Disorder 10 15 25
Bipolar II Disorder 9 7 16
Bipolar NOS 0 2 2
1.Primary Outcome
Title Time to Study Discontinuation
Hide Description The time, as measured in number of days, for discontinuation due to all causes will be measured and used as the primary outcome measure
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lithium Quetiapine
Hide Arm/Group Description:
Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L.
Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
Overall Number of Participants Analyzed 18 24
Mean (95% Confidence Interval)
Unit of Measure: days
41
(23 to 83)
77
(38 to 200)
2.Secondary Outcome
Title Lithium vs. Quetiapine Effects on General Cardiovascular Disease Risk as Measured by Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Hide Description Change in homeostatic model assessment for insulin resistance (HOMA-IR) from screening to end of study. Insulin resistance is a condition in which cells fail to respond to the normal actions of the hormone in the body. The HOMA-IR is calculated using a subject's fasting plasma insulin and glucose levels. The higher the score, the higher the level of insulin resistance.
Time Frame Screening and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lithium Quetiapine
Hide Arm/Group Description:
Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L.
Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
Overall Number of Participants Analyzed 18 24
Mean (Standard Deviation)
Unit of Measure: IR Score
-5.5  (15.9) 0.2  (1.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lithium Quetiapine
Hide Arm/Group Description Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L. Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
All-Cause Mortality
Lithium Quetiapine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lithium Quetiapine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      0/24 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lithium Quetiapine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/18 (88.89%)      21/24 (87.50%)    
Gastrointestinal disorders     
Stomach Upset  5/18 (27.78%)  5 0/24 (0.00%)  0
Nausea  4/18 (22.22%)  4 0/24 (0.00%)  0
Vomiting  1/18 (5.56%)  1 0/24 (0.00%)  0
Consitpation  0/18 (0.00%)  0 3/24 (12.50%)  3
General disorders     
Excessive sleepiness / daytime somnolence  7/18 (38.89%)  7 12/24 (50.00%)  12
Increased thirst  4/18 (22.22%)  4 4/24 (16.67%)  4
Insomnia  3/18 (16.67%)  3 0/24 (0.00%)  0
Headache  2/18 (11.11%)  2 2/24 (8.33%)  2
Muscle Stiffness  1/18 (5.56%)  1 1/24 (4.17%)  1
Cognitive Impairment  1/18 (5.56%)  1 3/24 (12.50%)  3
Unusual discomfort to warm temperatures  1/18 (5.56%)  1 0/24 (0.00%)  0
Increased Appetite  1/18 (5.56%)  1 2/24 (8.33%)  2
Weight Gain  1/18 (5.56%)  1 1/24 (4.17%)  1
Dizziness/Lightheadedness  1/18 (5.56%)  1 6/24 (25.00%)  6
Dry Mouth  0/18 (0.00%)  0 11/24 (45.83%)  11
Hot flashes  0/18 (0.00%)  0 2/24 (8.33%)  2
Nervous system disorders     
Tremor  2/18 (11.11%)  2 3/24 (12.50%)  3
Psychiatric disorders     
Irritability  0/18 (0.00%)  0 2/24 (8.33%)  2
Renal and urinary disorders     
Increased urination  2/18 (11.11%)  2 1/24 (4.17%)  1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Keming Gao, MD, PhD
Organization: University Hospitals Cleveland Medical Center
Phone: 216-844-2865
EMail: keming.gao@UHhospitals.org
Layout table for additonal information
Responsible Party: Keming Gao, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT01526148     History of Changes
Other Study ID Numbers: 09-11-01
First Submitted: January 25, 2012
First Posted: February 3, 2012
Results First Submitted: July 30, 2015
Results First Posted: October 30, 2015
Last Update Posted: August 16, 2017