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Trial record 32 of 450 for:    QUETIAPINE

Cardiovascular Biomarkers and Quetiapine in Depression and Anxiety Patients

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: NCT00951483
Recruitment Status : Completed
First Posted : August 4, 2009
Results First Posted : October 24, 2016
Last Update Posted : October 24, 2016
Sponsor:
Information provided by (Responsible Party):
Angelos Halaris, Loyola University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Depression
Anxiety
Intervention Drug: Quetiapine-XR
Enrollment 91
Recruitment Details Ninety-one individuals were consented and 47 participants received study drug while 44 participants enrolled as healthy control participants between July 2009 and October 2011. Participants were recruited using physician solicitation and advertisements.
Pre-assignment Details  
Arm/Group Title Intervention Cohort Healthy Control
Hide Arm/Group Description

Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.

Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks.

Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention. They will undergo baseline psychological and laboratory tests and will be followed for 12 weeks.
Period Title: Overall Study
Started 47 44
Completed 28 44
Not Completed 19 0
Reason Not Completed
Physician Decision             4             0
Withdrawal by Subject             15             0
Arm/Group Title Experimental Cohort Healthy Control Total
Hide Arm/Group Description

Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.

Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks.

Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention. They will undergo baseline psychological and laboratory tests and will be followed for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 47 44 91
Hide Baseline Analysis Population Description
Baseline analysis were conducted on all individuals who signed an informed consent document (N = 91)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 44 participants 91 participants
43.8  (12.1) 39.5  (13.8) 41.7  (13.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 44 participants 91 participants
Female
26
  55.3%
29
  65.9%
55
  60.4%
Male
21
  44.7%
15
  34.1%
36
  39.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants 44 participants 91 participants
Non-Hispanic White 22 30 52
African American 13 8 21
Asian 1 3 4
Hispanic White 11 3 14
Tobacco Use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants 44 participants 91 participants
Non-Smoker 22 40 62
Smoker 0 3 3
Unknown 25 1 26
Height   [1] 
Mean (Standard Deviation)
Unit of measure:  Meters
Number Analyzed 47 participants 44 participants 91 participants
1.66  (0.19) 1.68  (0.10) 1.67  (0.15)
[1]
Measure Description: Height was measured in meters
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 47 participants 44 participants 91 participants
88.50  (23.8) 74.59  (15.45) 81.86  (21.31)
[1]
Measure Description: Weight was measured in kilograms
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 47 participants 44 participants 91 participants
31.98  (6.76) 26.51  (5.77) 29.36  (6.84)
Menopausal Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants 44 participants 91 participants
Premenopausal 23 19 42
Postmenopausal 3 10 13
Not Applicable (Males) 21 15 36
Family History of Depression  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants 44 participants 91 participants
No 17 38 55
Yes 22 2 24
Unknown 8 4 12
Concomitant Psychiatric Medication  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants 44 participants 91 participants
Yes 26 1 27
No 16 42 58
Unknown 5 1 6
Family History of Alzheimer's Disease  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants 44 participants 91 participants
No 18 36 54
Yes 21 4 25
Unknown 8 4 12
Baseline Hamilton Rating Scale for Depression with Seven Items   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 47 participants 44 participants 91 participants
15
(13 to 19)
0
(0 to 1)
8
(0 to 15)
[1]
Measure Description: The seven item Hamilton Rating Scale for Depression (HAMD-7) is an objective assessment of depression administered by a trained rater. This version allows scores to range from 0 to 22, where higher scores indicate worsening mood.
Baseline Hamilton Rating Scale for Depression with 17 Items   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 47 participants 44 participants 91 participants
25
(20 to 29)
0
(0 to 2)
17
(0 to 25)
[1]
Measure Description: The 17-item Hamilton Rating Scale for Depression (HAMD-17) is an objective assessment of depression administered by a trained rater. This version allows scores to range from 0 to 52, where higher scores indicate worsening mood.
Baseline Hamilton Rating Scale for Depression with 21 Items   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 47 participants 44 participants 91 participants
27
(23 to 32)
0
(0 to 2)
18
(0 to 27)
[1]
Measure Description: The 21-item Hamilton Rating Scale for Depression (HAMD-21) is an objective assessment of depression administered by a trained rater. This version allows scores to range from 0 to 63, where higher scores indicate worsening mood.
Baseline Hamilton Rating Scale for Anxiety   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 47 participants 44 participants 91 participants
22
(15 to 28)
0
(0 to 1)
10
(0 to 22)
[1]
Measure Description: The 14-item Hamilton Rating Scale for Anxiety (HAM-A) is an objective assessment of anxiety administered by a trained rater. This version allows scores to range from 0 to 56, where higher scores indicate worsening anxiety.
Baseline Beck Depression Inventory   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 47 participants 44 participants 91 participants
25.50
(17.75 to 33.50)
0
(0 to 1.25)
16.50
(1.00 to 28.75)
[1]
Measure Description: The 21-item Beck Depression Inventory (BDI) is a subjective self-report assessment of depression. This version allows scores to range from 0 to 63, where higher scores indicate worsening mood.
Perceived Stress Scale with 14 Items   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 47 participants 44 participants 91 participants
49.50
(44.25 to 54.00)
27.00
(24.00 to 32.00)
43.50
(30.50 to 52.00)
[1]
Measure Description: The 14-item Perceived Stress Scale (PSS-14) is a subjective self-report assessment of stress. Each item is rated on a five point frequency scale ranging from 0 = never experiencing the stress symptom to 4 = Very often experiencing the stress symptom. Scores range from 0 to 56, where higher scores indicate higher stress.
1.Primary Outcome
Title C-Reactive Protein at 12 Weeks
Hide Description To compare C-Reactive Protein between the treatment and healthy control groups at 12 weeks post treatment.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Due to the cost for the C-reactive protein assay, only 20 individuals from each cohort are analyzed (N = 40).
Arm/Group Title Experimental Cohort Healthy Control
Hide Arm/Group Description:

Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.

Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks.

Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention. They will undergo baseline psychological and laboratory tests and will be followed for 12 weeks.
Overall Number of Participants Analyzed 20 20
Median (Inter-Quartile Range)
Unit of Measure: mg/L
3.31
(1.06 to 8.21)
0.50
(0.30 to 2.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental Cohort, Healthy Control
Comments The null hypothesis is that C-reactive protein (CRP) is no different between the experimental and healthy control cohorts at 12 weeks.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Standardized test statistic (z-score)
Estimated Value -2.65
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Hamilton Rating Scale for Depression With Seven Items (HAM-D-7)
Hide Description The seven item Hamilton Rating Scale for Depression (HAMD-7) is an objective assessment of depression administered by a trained rater. This version allows scores to range from 0 to 22, where higher scores indicate worsening mood.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis is restricted to the twenty-eight individuals from the intervention cohort who had valid HAM-D-7 responses at baseline and 12 weeks; the healthy control arm is not included here, because their HAM-D-7 scores were recorded at baseline only (see baseline characteristics).
Arm/Group Title Intervention Cohort Baseline Intervention Cohort End of Treatment
Hide Arm/Group Description:

Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.

Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks.

Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.

Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks.

Overall Number of Participants Analyzed 28 28
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
15.00
(12.25 to 19.75)
3.00
(0.00 to 10.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Cohort Baseline, Intervention Cohort End of Treatment
Comments The null hypothesis is that there is no difference between the intervention cohort's baseline HAM-D-7 score and end of treatment (i.e., 12 week) HAM-D-7 score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter z-score
Estimated Value -4.544
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in Hamilton Rating Scale for Depression With 17 Items (HAM-D-17)
Hide Description The 17-item Hamilton Rating Scale for Depression (HAMD-17) is an objective assessment of depression administered by a trained rater. This version allows scores to range from 0 to 52, where higher scores indicate worsening mood.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis is restricted to the twenty-eight individuals from the intervention cohort who had valid HAM-D-17 responses at baseline and 12 weeks; the healthy control arm is not included, because their HAM-D-17 scores were recorded at baseline only (see baseline characteristics).
Arm/Group Title Intervention Cohort Baseline Intervention Cohort End of Treatment
Hide Arm/Group Description:

Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.

Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks.

Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.

Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks.

Overall Number of Participants Analyzed 28 28
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
24.00
(20.00 to 28.75)
5.50
(1.00 to 14.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Cohort Baseline, Intervention Cohort End of Treatment
Comments The null hypothesis is that there is no difference between the intervention cohort's baseline HAMD-17 score and end of treatment (i.e., 12 week) HAMD-17 score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter z-score
Estimated Value -4.627
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Hamilton Rating Scale for Depression With 21 Items (HAMD-21)
Hide Description The 21-item Hamilton Rating Scale for Depression (HAMD-21) is an objective assessment of depression administered by a trained rater. This version allows scores to range from 0 to 52, where higher scores indicate worsening mood.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis is restricted to the twenty-eight individuals from the intervention cohort had valid HAM-D-21 responses at baseline and 12 weeks; the healthy control arm is not included, because their HAM-D-21 scores were recorded at baseline only (see baseline characteristics).
Arm/Group Title Intervention Cohort Baseline Intervention Cohort End of Treatment
Hide Arm/Group Description:

Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.

Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks.

Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.

Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks.

Overall Number of Participants Analyzed 28 28
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
26.50
(22.50 to 32.00)
6.50
(1.25 to 16.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Cohort Baseline, Intervention Cohort End of Treatment
Comments The null hypothesis is that there is no difference between the intervention cohort's baseline HAMD-21 score and end of treatment (i.e., 12 week) HAMD-21 score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter z-score
Estimated Value -4.624
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in Hamilton Rating Scale for Anxiety (HAM-A)
Hide Description The 14-item Hamilton Rating Scale for Anxiety (HAM-A) is an objective assessment of anxiety administered by a trained rater. This version allows scores to range from 0 to 56, where higher scores indicate worsening anxiety.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis is restricted to the twenty-eight individuals from the intervention cohort had valid HAM-A responses at baseline and 12 weeks; the healthy control arm is not included, because their HAM-A scores were recorded at baseline only (see baseline characteristics).
Arm/Group Title Intervention Cohort Baseline Intervention Cohort End of Treatment
Hide Arm/Group Description:

Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.

Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks.

Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.

Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks.

Overall Number of Participants Analyzed 28 28
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
22.00
(15.25 to 28.00)
6.00
(1.25 to 10.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Cohort Baseline, Intervention Cohort End of Treatment
Comments The null hypothesis is that there is no difference between the intervention cohort's baseline HAM-A score and end of treatment (i.e., 12 week) HAM-A score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter z-score
Estimated Value -4.510
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change in Beck Depression Inventory (BDI)
Hide Description The 21-item Beck Depression Inventory (BDI) is a subjective self-report assessment of depression. This version allows scores to range from 0 to 63, where higher scores indicate worsening mood.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis is restricted to the twenty-seven individuals from the intervention cohort had valid BDI responses at baseline and 12 weeks; the healthy control arm is not included, because their BDI scores were recorded at baseline only (see baseline characteristics).
Arm/Group Title Intervention Cohort Baseline Intervention Cohort End of Treatment
Hide Arm/Group Description:

Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.

Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks.

Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.

Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks.

Overall Number of Participants Analyzed 27 27
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
25.00
(17.00 to 33.00)
6.00
(1.00 to 18.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Cohort Baseline, Intervention Cohort End of Treatment
Comments The null hypothesis is that there is no difference between the intervention cohort's baseline BDI score and end of treatment (i.e., 12 week) BDI score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter z-score
Estimated Value -4.435
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change in 14-item Perceived Stress Scale (PSS-14)
Hide Description The 14-item Perceived Stress Scale (PSS-14) is a subjective self-report assessment of stress. Each item is rated on a five point frequency scale ranging from 0 = never experiencing the stress symptom to 4 = Very often experiencing the stress symptom. Scores range from 0 to 56, where higher scores indicate higher stress.
Time Frame Baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis is restricted to the twenty-three individuals from the intervention cohort had valid PSS-14 responses at baseline and 12 weeks; the healthy control arm is not included, because their PSS-14 scores were recorded at baseline only (see baseline characteristics).
Arm/Group Title Intervention Cohort Baseline Intervention Cohort End of Treatment
Hide Arm/Group Description:

Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.

Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks.

Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.

Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks.

Overall Number of Participants Analyzed 23 23
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
50.00
(43.00 to 54.00)
35.00
(26.00 to 44.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Cohort Baseline, Intervention Cohort End of Treatment
Comments The null hypothesis is that there is no difference between the intervention cohort's baseline PSS-14 score and end of treatment (i.e., 12 week) PSS-14 score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Wilcoxon signed rank test
Comments [Not Specified]
Method of Estimation Estimation Parameter z-score
Estimated Value -3.911
Estimation Comments [Not Specified]
Time Frame Adverse event data were collected during the 12 Week trial.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Experimental Cohort Healthy Control
Hide Arm/Group Description

Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.

Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks.

Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention. They will undergo baseline psychological and laboratory tests and will be followed for 12 weeks.
All-Cause Mortality
Experimental Cohort Healthy Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Experimental Cohort Healthy Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/47 (0.00%)      0/44 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Experimental Cohort Healthy Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/47 (82.98%)      0/44 (0.00%)    
Gastrointestinal disorders     
Dry mouth *  13/47 (27.66%)  13 0/44 (0.00%)  0
General disorders     
Fatigue *  6/47 (12.77%)  6 0/44 (0.00%)  0
Insomnia *  3/47 (6.38%)  3 0/44 (0.00%)  0
Drowsiness *  10/47 (21.28%)  10 0/44 (0.00%)  0
Increased appetite *  5/47 (10.64%)  5 0/44 (0.00%)  0
Increased irritability *  5/47 (10.64%)  5 0/44 (0.00%)  0
Metabolism and nutrition disorders     
Weight gain *  5/47 (10.64%)  5 0/44 (0.00%)  0
Psychiatric disorders     
Increased anxiety *  7/47 (14.89%)  7 0/44 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Angelos Halaris, MD, PhD
Organization: Loyola University Chicago
Phone: 708-216-3275
EMail: ahalaris@lumc.edu
Layout table for additonal information
Responsible Party: Angelos Halaris, Loyola University
ClinicalTrials.gov Identifier: NCT00951483     History of Changes
Other Study ID Numbers: 201880
First Submitted: July 31, 2009
First Posted: August 4, 2009
Results First Submitted: April 20, 2015
Results First Posted: October 24, 2016
Last Update Posted: October 24, 2016