Trial Outcomes & Findings for Seroquel Alone Versus Seroquel With an SSRI for Depression With Psychotic Symptoms (NCT NCT00955474)
NCT ID: NCT00955474
Last Updated: 2017-04-20
Results Overview
Depression measured with Hamilton Rating Scale for Depression 17 (HAM-D) at baseline and 8 weeks. Ham D 17 scores range from 0-52, 52 being the most severe.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
32 participants
Primary outcome timeframe
8 weeks
Results posted on
2017-04-20
Participant Flow
Participants were recruitment through newspaper advertisements in the Boston metro area.
Participants were required to wash-out prior to randomization and study procedures. If the patient was unable to wash-out (by personal choice or doctor's recommendation), they were excluded. Seven subjects withdrew consent prior to randomization.
Participant milestones
| Measure |
Quetiapine
Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.
|
Quetiapine and SSRI
Patients assigned to receive Quetiapine and SSRI
* Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
* Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
* Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
* Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
|
Overall Study
COMPLETED
|
5
|
8
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
| Measure |
Quetiapine
Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.
|
Quetiapine and SSRI
Patients assigned to receive Quetiapine and SSRI
* Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
* Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
* Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
* Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
|
|---|---|---|
|
Overall Study
Physician Decision
|
7
|
5
|
Baseline Characteristics
Seroquel Alone Versus Seroquel With an SSRI for Depression With Psychotic Symptoms
Baseline characteristics by cohort
| Measure |
Quetiapine
n=12 Participants
Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.
|
Quetiapine and SSRI
n=13 Participants
Patients assigned to receive Quetiapine and SSRI
* Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
* Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
* Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
* Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
39.25 years
n=5 Participants
|
42.85 years
n=7 Participants
|
40.32 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were five completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.
Depression measured with Hamilton Rating Scale for Depression 17 (HAM-D) at baseline and 8 weeks. Ham D 17 scores range from 0-52, 52 being the most severe.
Outcome measures
| Measure |
Quetiapine
n=12 Participants
Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.
|
Quetiapine With SSRI
n=11 Participants
Patients assigned to receive Quetiapine and SSRI
* Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
* Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
* Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
* Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
|
|---|---|---|
|
Depression
Last visit
|
9.57 units on a scale
Standard Deviation 5.44
|
10.14 units on a scale
Standard Deviation 8.40
|
|
Depression
Baseline
|
27 units on a scale
Standard Deviation 16.21
|
26.73 units on a scale
Standard Deviation 6.84
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Complete missing data for 2 subjects in the quetiapine with SSRI group (11 of 13 have baseline outcome measures). There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.
Psychosis measured by Brief Psychosis Rating Scale (BPRS) at baseline and 8 weeks. Scores range from 24-168, with 168 bring the most severe.
Outcome measures
| Measure |
Quetiapine
n=12 Participants
Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.
|
Quetiapine With SSRI
n=11 Participants
Patients assigned to receive Quetiapine and SSRI
* Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
* Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
* Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
* Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
|
|---|---|---|
|
Psychosis
Baseline
|
56.09 units on a scale
Standard Deviation 7.26
|
60.45 units on a scale
Standard Deviation 16.49
|
|
Psychosis
Last visit
|
34.25 units on a scale
Standard Deviation 25.04
|
32.83 units on a scale
Standard Deviation 8.98
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were five completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.
Fasting glucose levels collected at Baseline and Week 8. Normal range for fasting glucose is 70-110 mg/dl.
Outcome measures
| Measure |
Quetiapine
n=12 Participants
Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.
|
Quetiapine With SSRI
n=11 Participants
Patients assigned to receive Quetiapine and SSRI
* Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
* Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
* Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
* Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
|
|---|---|---|
|
Fasting Blood Glucose
Week 8
|
89.1 ml/dl
Standard Deviation 2.2
|
96.8 ml/dl
Standard Deviation 19.2
|
|
Fasting Blood Glucose
Baseline
|
91.6 ml/dl
Standard Deviation 10.2
|
89.4 ml/dl
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.
Score on the Cognitive and Psychological Functioning Questionnaire (CPFQ). Scores range from 7-42 with 42 referring to the worst functioning. CPFQ measured at baseline and 8 weeks.
Outcome measures
| Measure |
Quetiapine
n=12 Participants
Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.
|
Quetiapine With SSRI
n=11 Participants
Patients assigned to receive Quetiapine and SSRI
* Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
* Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
* Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
* Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
|
|---|---|---|
|
CPFQ (Cognitive and Psychological Functioning Questionnaire)
Baseline
|
30.8 units on a scale
Standard Deviation 4.69
|
29.3 units on a scale
Standard Deviation 9.24
|
|
CPFQ (Cognitive and Psychological Functioning Questionnaire)
Last visit
|
23.56 units on a scale
Standard Deviation 7.07
|
21.00 units on a scale
Standard Deviation 6.40
|
SECONDARY outcome
Timeframe: 8Population: Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.
Neuropsychological Assessment. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score \<70 moderate to severe impairment. RBANS measured at baseline and 8 weeks.
Outcome measures
| Measure |
Quetiapine
n=12 Participants
Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.
|
Quetiapine With SSRI
n=11 Participants
Patients assigned to receive Quetiapine and SSRI
* Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
* Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
* Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
* Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
|
|---|---|---|
|
RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Total Score
Baseline
|
77.38 units on a scale
Standard Deviation 13.71
|
70.00 units on a scale
Standard Deviation 16.12
|
|
RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Total Score
Last visit
|
77.25 units on a scale
Standard Deviation 15.23
|
78.29 units on a scale
Standard Deviation 16.94
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.
RBANS Immediate Memory sub-scale scores at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score \<70 moderate to severe impairment.
Outcome measures
| Measure |
Quetiapine
n=12 Participants
Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.
|
Quetiapine With SSRI
n=11 Participants
Patients assigned to receive Quetiapine and SSRI
* Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
* Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
* Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
* Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
|
|---|---|---|
|
RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Immediate Memory Sub-scale Score
Week 8
|
82.8 units on a scale
Standard Deviation 14.4
|
77.9 units on a scale
Standard Deviation 16.2
|
|
RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Immediate Memory Sub-scale Score
Baseline
|
83.3 units on a scale
Standard Deviation 17.2
|
71.1 units on a scale
Standard Deviation 14.1
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.
RBANS Visuospatial/Constructional sub-scales at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score \<70 moderate to severe impairment.
Outcome measures
| Measure |
Quetiapine
n=12 Participants
Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.
|
Quetiapine With SSRI
n=11 Participants
Patients assigned to receive Quetiapine and SSRI
* Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
* Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
* Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
* Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
|
|---|---|---|
|
RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Visuospatial/Constructional Sub-scale.
Week 8
|
70.5 units on a scale
Standard Deviation 30.8
|
78.3 units on a scale
Standard Deviation 17.8
|
|
RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Visuospatial/Constructional Sub-scale.
Baseline
|
70.6 units on a scale
Standard Deviation 15.9
|
75.6 units on a scale
Standard Deviation 16.1
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.
RBANS Language sub-scale scores at Baseline and Week 8 of study. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score \<70 moderate to severe impairment.
Outcome measures
| Measure |
Quetiapine
n=12 Participants
Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.
|
Quetiapine With SSRI
n=11 Participants
Patients assigned to receive Quetiapine and SSRI
* Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
* Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
* Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
* Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
|
|---|---|---|
|
RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Language Sub-scale Score.
Baseline
|
80.4 units on a scale
Standard Deviation 16.2
|
77.6 units on a scale
Standard Deviation 21.2
|
|
RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Language Sub-scale Score.
Week 8
|
87.9 units on a scale
Standard Deviation 13.7
|
91.1 units on a scale
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.
RBANS Attention sub-scale scores at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score \<70 moderate to severe impairment.
Outcome measures
| Measure |
Quetiapine
n=12 Participants
Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.
|
Quetiapine With SSRI
n=11 Participants
Patients assigned to receive Quetiapine and SSRI
* Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
* Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
* Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
* Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
|
|---|---|---|
|
RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Attention Sub-scale Scores at Baseline and Week 8.
Week 8
|
104.6 units on a scale
Standard Deviation 21.6
|
86.1 units on a scale
Standard Deviation 11.0
|
|
RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Attention Sub-scale Scores at Baseline and Week 8.
Baseline
|
95.8 units on a scale
Standard Deviation 17.1
|
85.4 units on a scale
Standard Deviation 15.9
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.
RBANS Delayed Memory subscale scores at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score \<70 moderate to severe impairment.
Outcome measures
| Measure |
Quetiapine
n=12 Participants
Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.
|
Quetiapine With SSRI
n=11 Participants
Patients assigned to receive Quetiapine and SSRI
* Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
* Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
* Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
* Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
|
|---|---|---|
|
RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Delayed Memory Subscale Scores at Baseline and Week 8.
Baseline
|
82.4 units on a scale
Standard Deviation 21.6
|
69.6 units on a scale
Standard Deviation 22.3
|
|
RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Delayed Memory Subscale Scores at Baseline and Week 8.
Week 8
|
72.9 units on a scale
Standard Deviation 13.7
|
74.7 units on a scale
Standard Deviation 24.3
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.
Cholesterol levels were collected at Baseline and Week 8. Normal cholesterol levels should be \<200mg/dl.
Outcome measures
| Measure |
Quetiapine
n=12 Participants
Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.
|
Quetiapine With SSRI
n=11 Participants
Patients assigned to receive Quetiapine and SSRI
* Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
* Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
* Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
* Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
|
|---|---|---|
|
Blood Level of Total Cholesterol Levels Were Collected at Baseline and Week 8.
Baseline
|
184.2 mg/dl
Standard Deviation 34.4
|
171.8 mg/dl
Standard Deviation 38.8
|
|
Blood Level of Total Cholesterol Levels Were Collected at Baseline and Week 8.
Week 8
|
188 mg/dl
Standard Deviation 2.2
|
201.7 mg/dl
Standard Deviation 55.8
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.
Level of triglycerides at Baseline and Week 8. Normal range: 40-150mg/dl.
Outcome measures
| Measure |
Quetiapine
n=12 Participants
Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.
|
Quetiapine With SSRI
n=11 Participants
Patients assigned to receive Quetiapine and SSRI
* Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
* Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
* Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
* Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
|
|---|---|---|
|
Blood Level of Triglycerides at Baseline and Week 8.
Baseline
|
144.9 mg/dl
Standard Deviation 71.1
|
154.25 mg/dl
Standard Deviation 80.5
|
|
Blood Level of Triglycerides at Baseline and Week 8.
Week 8
|
170.6 mg/dl
Standard Deviation 125.2
|
190.5 mg/dl
Standard Deviation 68.5
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.
HDL levels at Baseline and Week 8. Normal range: 35-100 mg/dl.
Outcome measures
| Measure |
Quetiapine
n=12 Participants
Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.
|
Quetiapine With SSRI
n=11 Participants
Patients assigned to receive Quetiapine and SSRI
* Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
* Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
* Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
* Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
|
|---|---|---|
|
HDL Blood Levels at Baseline and Week 8.
Baseline
|
47.7 mg/dl
Standard Deviation 15.1
|
45.3 mg/dl
Standard Deviation 6.6
|
|
HDL Blood Levels at Baseline and Week 8.
Week 8
|
40.8 mg/dl
Standard Deviation 13.2
|
40.5 mg/dl
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.
LDL levels at Baseline and Week 8. Normal range \< 100 mg/dl.
Outcome measures
| Measure |
Quetiapine
n=12 Participants
Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.
|
Quetiapine With SSRI
n=11 Participants
Patients assigned to receive Quetiapine and SSRI
* Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
* Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
* Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
* Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
|
|---|---|---|
|
LDL Blood Levels at Baseline and Week 8.
Baseline
|
109 mg/dl
Standard Deviation 25.3
|
94.6 mg/dl
Standard Deviation 27.3
|
|
LDL Blood Levels at Baseline and Week 8.
Week 8
|
121.1 mg/dl
Standard Deviation 39.4
|
123.3 mg/dl
Standard Deviation 42.2
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: Missing data for two subjects in the quetiapine with SSRI group;11 of 13 have baseline outcome measures. There were 5 completers (8 weeks) in the quetiapine group and 8 completers (8 weeks) in the quetiapine with SSRI group.
Blood hemoglobin A1C at Baseline and Week 8. Normal range: 3.8%-6.4%.
Outcome measures
| Measure |
Quetiapine
n=12 Participants
Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.
|
Quetiapine With SSRI
n=11 Participants
Patients assigned to receive Quetiapine and SSRI
* Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
* Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
* Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
* Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
|
|---|---|---|
|
Blood Hemoglobin A1C at Baseline and Week 8.
Baseline
|
5.6 % glycated hemoglobin
Standard Deviation 0.5
|
5.7 % glycated hemoglobin
Standard Deviation 0.5
|
|
Blood Hemoglobin A1C at Baseline and Week 8.
Week 8
|
5.4 % glycated hemoglobin
Standard Deviation 0.5
|
5.8 % glycated hemoglobin
Standard Deviation 0.3
|
Adverse Events
Quetiapine
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Quetiapine and SSRI
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Quetiapine
n=12 participants at risk
Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.
|
Quetiapine and SSRI
n=13 participants at risk
Patients assigned to receive Quetiapine and SSRI
* Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
* Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
* Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
* Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
|
|---|---|---|
|
Nervous system disorders
Acute mania
|
0.00%
0/12 • 8 weeks
|
7.7%
1/13 • 8 weeks
|
|
Psychiatric disorders
Worsening depression
|
8.3%
1/12 • Number of events 1 • 8 weeks
|
0.00%
0/13 • 8 weeks
|
|
Psychiatric disorders
Increased paranoia and auditory hallucinations
|
8.3%
1/12 • Number of events 1 • 8 weeks
|
0.00%
0/13 • 8 weeks
|
Other adverse events
| Measure |
Quetiapine
n=12 participants at risk
Patients assigned to receive Quetiapine
•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study.
|
Quetiapine and SSRI
n=13 participants at risk
Patients assigned to receive Quetiapine and SSRI
* Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.
* Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.
* Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.
* Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m.
|
|---|---|---|
|
Psychiatric disorders
Excess sedation
|
16.7%
2/12 • Number of events 2 • 8 weeks
|
30.8%
4/13 • Number of events 4 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Leg cramps
|
0.00%
0/12 • 8 weeks
|
15.4%
2/13 • Number of events 2 • 8 weeks
|
|
Nervous system disorders
Fatigue
|
16.7%
2/12 • Number of events 2 • 8 weeks
|
38.5%
5/13 • Number of events 5 • 8 weeks
|
|
Gastrointestinal disorders
Constipation
|
16.7%
2/12 • Number of events 2 • 8 weeks
|
7.7%
1/13 • Number of events 1 • 8 weeks
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Number of events 1 • 8 weeks
|
0.00%
0/13 • 8 weeks
|
|
Psychiatric disorders
Dreaming
|
0.00%
0/12 • 8 weeks
|
7.7%
1/13 • Number of events 1 • 8 weeks
|
|
Nervous system disorders
Headaches
|
0.00%
0/12 • 8 weeks
|
7.7%
1/13 • Number of events 1 • 8 weeks
|
|
Cardiac disorders
Light headedness
|
8.3%
1/12 • Number of events 1 • 8 weeks
|
7.7%
1/13 • Number of events 1 • 8 weeks
|
|
Nervous system disorders
Dry mouth
|
25.0%
3/12 • Number of events 3 • 8 weeks
|
15.4%
2/13 • Number of events 2 • 8 weeks
|
|
Musculoskeletal and connective tissue disorders
Hand weakness
|
8.3%
1/12 • Number of events 1 • 8 weeks
|
0.00%
0/13 • 8 weeks
|
|
Nervous system disorders
Sweating
|
0.00%
0/12 • 8 weeks
|
15.4%
2/13 • Number of events 2 • 8 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/12 • 8 weeks
|
7.7%
1/13 • Number of events 1 • 8 weeks
|
|
Nervous system disorders
Carbohydrate cravings
|
0.00%
0/12 • 8 weeks
|
7.7%
1/13 • Number of events 1 • 8 weeks
|
|
Eye disorders
Blurred vision
|
0.00%
0/12 • 8 weeks
|
7.7%
1/13 • Number of events 1 • 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place