Trial Outcomes & Findings for Cardiovascular Biomarkers and Quetiapine in Depression and Anxiety Patients (NCT NCT00951483)
NCT ID: NCT00951483
Last Updated: 2016-10-24
Results Overview
To compare C-Reactive Protein between the treatment and healthy control groups at 12 weeks post treatment.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
91 participants
Primary outcome timeframe
12 weeks
Results posted on
2016-10-24
Participant Flow
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.
Participant milestones
| Measure |
Intervention Cohort
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.
|
Healthy Control
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 Study
STARTED
|
47
|
44
|
|
Overall Study
COMPLETED
|
28
|
44
|
|
Overall Study
NOT COMPLETED
|
19
|
0
|
Reasons for withdrawal
| Measure |
Intervention Cohort
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.
|
Healthy Control
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 Study
Physician Decision
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
15
|
0
|
Baseline Characteristics
Cardiovascular Biomarkers and Quetiapine in Depression and Anxiety Patients
Baseline characteristics by cohort
| Measure |
Experimental Cohort
n=47 Participants
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.
|
Healthy Control
n=44 Participants
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
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.8 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
39.5 years
STANDARD_DEVIATION 13.8 • n=7 Participants
|
41.7 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
22 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic White
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Tobacco Use
Non-Smoker
|
22 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Tobacco Use
Smoker
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Tobacco Use
Unknown
|
25 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Height
|
1.66 Meters
STANDARD_DEVIATION 0.19 • n=5 Participants
|
1.68 Meters
STANDARD_DEVIATION 0.10 • n=7 Participants
|
1.67 Meters
STANDARD_DEVIATION 0.15 • n=5 Participants
|
|
Weight
|
88.50 kilograms
STANDARD_DEVIATION 23.8 • n=5 Participants
|
74.59 kilograms
STANDARD_DEVIATION 15.45 • n=7 Participants
|
81.86 kilograms
STANDARD_DEVIATION 21.31 • n=5 Participants
|
|
Body Mass Index (BMI)
|
31.98 kg/m^2
STANDARD_DEVIATION 6.76 • n=5 Participants
|
26.51 kg/m^2
STANDARD_DEVIATION 5.77 • n=7 Participants
|
29.36 kg/m^2
STANDARD_DEVIATION 6.84 • n=5 Participants
|
|
Menopausal Status
Premenopausal
|
23 participants
n=5 Participants
|
19 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Menopausal Status
Postmenopausal
|
3 participants
n=5 Participants
|
10 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
Menopausal Status
Not Applicable (Males)
|
21 participants
n=5 Participants
|
15 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Family History of Depression
No
|
17 participants
n=5 Participants
|
38 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Family History of Depression
Yes
|
22 participants
n=5 Participants
|
2 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Family History of Depression
Unknown
|
8 participants
n=5 Participants
|
4 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Concomitant Psychiatric Medication
Yes
|
26 participants
n=5 Participants
|
1 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Concomitant Psychiatric Medication
No
|
16 participants
n=5 Participants
|
42 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Concomitant Psychiatric Medication
Unknown
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Family History of Alzheimer's Disease
No
|
18 participants
n=5 Participants
|
36 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Family History of Alzheimer's Disease
Yes
|
21 participants
n=5 Participants
|
4 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Family History of Alzheimer's Disease
Unknown
|
8 participants
n=5 Participants
|
4 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Baseline Hamilton Rating Scale for Depression with Seven Items
|
15 units on a scale
n=5 Participants
|
0 units on a scale
n=7 Participants
|
8 units on a scale
n=5 Participants
|
|
Baseline Hamilton Rating Scale for Depression with 17 Items
|
25 units on a scale
n=5 Participants
|
0 units on a scale
n=7 Participants
|
17 units on a scale
n=5 Participants
|
|
Baseline Hamilton Rating Scale for Depression with 21 Items
|
27 units on a scale
n=5 Participants
|
0 units on a scale
n=7 Participants
|
18 units on a scale
n=5 Participants
|
|
Baseline Hamilton Rating Scale for Anxiety
|
22 units on a scale
n=5 Participants
|
0 units on a scale
n=7 Participants
|
10 units on a scale
n=5 Participants
|
|
Baseline Beck Depression Inventory
|
25.50 units on a scale
n=5 Participants
|
0 units on a scale
n=7 Participants
|
16.50 units on a scale
n=5 Participants
|
|
Perceived Stress Scale with 14 Items
|
49.50 units on a scale
n=5 Participants
|
27.00 units on a scale
n=7 Participants
|
43.50 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Due to the cost for the C-reactive protein assay, only 20 individuals from each cohort are analyzed (N = 40).
To compare C-Reactive Protein between the treatment and healthy control groups at 12 weeks post treatment.
Outcome measures
| Measure |
Healthy Control
n=20 Participants
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.
|
Intervention Cohort Baseline
n=20 Participants
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.
|
|---|---|---|
|
C-Reactive Protein at 12 Weeks
|
0.50 mg/L
Interval 0.3 to 2.4
|
3.31 mg/L
Interval 1.06 to 8.21
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: 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).
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.
Outcome measures
| Measure |
Healthy Control
n=28 Participants
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.
|
Intervention Cohort Baseline
n=28 Participants
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.
|
|---|---|---|
|
Change in Hamilton Rating Scale for Depression With Seven Items (HAM-D-7)
|
3.00 units on a scale
Interval 0.0 to 10.75
|
15.00 units on a scale
Interval 12.25 to 19.75
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: 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).
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.
Outcome measures
| Measure |
Healthy Control
n=28 Participants
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.
|
Intervention Cohort Baseline
n=28 Participants
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.
|
|---|---|---|
|
Change in Hamilton Rating Scale for Depression With 17 Items (HAM-D-17)
|
5.50 units on a scale
Interval 1.0 to 14.75
|
24.00 units on a scale
Interval 20.0 to 28.75
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: 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).
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.
Outcome measures
| Measure |
Healthy Control
n=28 Participants
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.
|
Intervention Cohort Baseline
n=28 Participants
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.
|
|---|---|---|
|
Change in Hamilton Rating Scale for Depression With 21 Items (HAMD-21)
|
6.50 units on a scale
Interval 1.25 to 16.75
|
26.50 units on a scale
Interval 22.5 to 32.0
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: 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).
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.
Outcome measures
| Measure |
Healthy Control
n=28 Participants
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.
|
Intervention Cohort Baseline
n=28 Participants
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.
|
|---|---|---|
|
Change in Hamilton Rating Scale for Anxiety (HAM-A)
|
6.00 units on a scale
Interval 1.25 to 10.0
|
22.00 units on a scale
Interval 15.25 to 28.0
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: 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).
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.
Outcome measures
| Measure |
Healthy Control
n=27 Participants
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.
|
Intervention Cohort Baseline
n=27 Participants
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.
|
|---|---|---|
|
Change in Beck Depression Inventory (BDI)
|
6.00 units on a scale
Interval 1.0 to 18.0
|
25.00 units on a scale
Interval 17.0 to 33.0
|
SECONDARY outcome
Timeframe: Baseline and 12 weeksPopulation: 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).
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.
Outcome measures
| Measure |
Healthy Control
n=23 Participants
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.
|
Intervention Cohort Baseline
n=23 Participants
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.
|
|---|---|---|
|
Change in 14-item Perceived Stress Scale (PSS-14)
|
35.00 units on a scale
Interval 26.0 to 44.0
|
50.00 units on a scale
Interval 43.0 to 54.0
|
Adverse Events
Experimental Cohort
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Healthy Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental Cohort
n=47 participants at risk
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.
|
Healthy Control
n=44 participants at risk
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.
|
|---|---|---|
|
Metabolism and nutrition disorders
Weight gain
|
10.6%
5/47 • Number of events 5 • Adverse event data were collected during the 12 Week trial.
|
0.00%
0/44 • Adverse event data were collected during the 12 Week trial.
|
|
General disorders
Fatigue
|
12.8%
6/47 • Number of events 6 • Adverse event data were collected during the 12 Week trial.
|
0.00%
0/44 • Adverse event data were collected during the 12 Week trial.
|
|
General disorders
Insomnia
|
6.4%
3/47 • Number of events 3 • Adverse event data were collected during the 12 Week trial.
|
0.00%
0/44 • Adverse event data were collected during the 12 Week trial.
|
|
General disorders
Drowsiness
|
21.3%
10/47 • Number of events 10 • Adverse event data were collected during the 12 Week trial.
|
0.00%
0/44 • Adverse event data were collected during the 12 Week trial.
|
|
Gastrointestinal disorders
Dry mouth
|
27.7%
13/47 • Number of events 13 • Adverse event data were collected during the 12 Week trial.
|
0.00%
0/44 • Adverse event data were collected during the 12 Week trial.
|
|
General disorders
Increased appetite
|
10.6%
5/47 • Number of events 5 • Adverse event data were collected during the 12 Week trial.
|
0.00%
0/44 • Adverse event data were collected during the 12 Week trial.
|
|
General disorders
Increased irritability
|
10.6%
5/47 • Number of events 5 • Adverse event data were collected during the 12 Week trial.
|
0.00%
0/44 • Adverse event data were collected during the 12 Week trial.
|
|
Psychiatric disorders
Increased anxiety
|
14.9%
7/47 • Number of events 7 • Adverse event data were collected during the 12 Week trial.
|
0.00%
0/44 • Adverse event data were collected during the 12 Week trial.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place