Trial Outcomes & Findings for Efficacy of Extended-release Quetiapine (Seroquel XR) as Adjunctive Therapy to Cognitive Behavioral Therapy in the Treat (NCT NCT01971203)
NCT ID: NCT01971203
Last Updated: 2018-02-15
Results Overview
Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician-administered, with overall score ranges from 0 (normal) to 54 (severe depression). Score at 16 weeks as compared to baseline.
COMPLETED
NA
62 participants
baseline and 16 weeks
2018-02-15
Participant Flow
Participants were recruited through the Mount Sinai faculty referrals, medical center employee newsletter, and advertisements in local newspapers, radio, and craigslist.
Ninety-four participants were screened - 10 participants did not meet study eligibility, 22 elected not to continue. 62 participants were randomized, but 7 never returned for the first visit, leaving 55 participants who began treatment.
Participant milestones
| Measure |
Seroquel XR Plus CBT
Participants were required to take a minimum of one 50 mg pill of quetiapine XR a day with an intended titration schedule reaching 150 mg over the first three weeks, adding one pill per week. . If a participant could not tolerate the increased dose, then dosage was decreased to either one or two pills a day.
All participants who completed the study received 16 sessions of CBT and discontinued medication at 16 weeks. Although conducted weekly, CBT and medication schedules did not always terminate at the same time.
|
Placebo Plus CBT
matching placebo pills plus 16 weeks of Cognitive Behavioral Therapy
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
29
|
|
Overall Study
COMPLETED
|
17
|
21
|
|
Overall Study
NOT COMPLETED
|
9
|
8
|
Reasons for withdrawal
| Measure |
Seroquel XR Plus CBT
Participants were required to take a minimum of one 50 mg pill of quetiapine XR a day with an intended titration schedule reaching 150 mg over the first three weeks, adding one pill per week. . If a participant could not tolerate the increased dose, then dosage was decreased to either one or two pills a day.
All participants who completed the study received 16 sessions of CBT and discontinued medication at 16 weeks. Although conducted weekly, CBT and medication schedules did not always terminate at the same time.
|
Placebo Plus CBT
matching placebo pills plus 16 weeks of Cognitive Behavioral Therapy
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
5
|
6
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Efficacy of Extended-release Quetiapine (Seroquel XR) as Adjunctive Therapy to Cognitive Behavioral Therapy in the Treat
Baseline characteristics by cohort
| Measure |
Seroquel XR Plus CBT
n=30 Participants
Participants were required to take a minimum of one 50 mg pill of quetiapine XR a day with an intended titration schedule reaching 150 mg over the first three weeks, adding one pill per week. . If a participant could not tolerate the increased dose, then dosage was decreased to either one or two pills a day.
All participants who completed the study received 16 sessions of CBT and discontinued medication at 16 weeks. Although conducted weekly, CBT and medication schedules did not always terminate at the same time.
|
Placebo Plus CBT
n=32 Participants
matching placebo pills plus 16 weeks of Cognitive Behavioral Therapy
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.93 years
STANDARD_DEVIATION 13.68 • n=93 Participants
|
39.88 years
STANDARD_DEVIATION 12.81 • n=4 Participants
|
39.90 years
STANDARD_DEVIATION 13.12 • n=27 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
19 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Education
Less than HS
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Education
HS
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Education
Part college
|
3 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Education
College
|
13 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Education
Advanced
|
8 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Education
Unknown
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: baseline and 16 weeksMontgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician-administered, with overall score ranges from 0 (normal) to 54 (severe depression). Score at 16 weeks as compared to baseline.
Outcome measures
| Measure |
Seroquel XR Plus CBT
n=26 Participants
Participants were required to take a minimum of one 50 mg pill of quetiapine XR a day.
|
Placebo Plus CBT
n=29 Participants
matching placebo pills plus 16 weeks of Cognitive Behavioral Therapy
|
|---|---|---|
|
MADRS
LOCF (last observation carried forward)
|
9.1 units on a scale
Standard Deviation 6.9
|
15.7 units on a scale
Standard Deviation 11.9
|
|
MADRS
Baseline
|
27.1 units on a scale
Standard Deviation 5.5
|
28.6 units on a scale
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: baseline and 16 weeksHamilton Rating Scale for Anxiety (HAM-A) is a 14-item clinician-administered scale measuring symptoms with total scale from 0 (not present) to 56 (severe) to severe anxiety.
Outcome measures
| Measure |
Seroquel XR Plus CBT
n=26 Participants
Participants were required to take a minimum of one 50 mg pill of quetiapine XR a day.
|
Placebo Plus CBT
n=29 Participants
matching placebo pills plus 16 weeks of Cognitive Behavioral Therapy
|
|---|---|---|
|
HAM-A
Baseline
|
16.7 units on a scale
Standard Deviation 5.2
|
17.8 units on a scale
Standard Deviation 4.7
|
|
HAM-A
LOCF (last observation carried forward)
|
5.9 units on a scale
Standard Deviation 3.9
|
9.4 units on a scale
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: up to 16 weeksThe Clinical Global Impression Scales for Severity and Improvement (CGI-I and CGI-S), both clinician rated, measures overall severity of symptoms and level of improvement on a seven-point scale from 0 (not applicable or not assessed) to 7, where 7 is the most severe. In order for a participant to be considered a treatment responder, he or she must receive a score of 1 (not ill or very much improved) or 2 (borderline mentally ill or much improved).
Outcome measures
| Measure |
Seroquel XR Plus CBT
n=26 Participants
Participants were required to take a minimum of one 50 mg pill of quetiapine XR a day.
|
Placebo Plus CBT
n=29 Participants
matching placebo pills plus 16 weeks of Cognitive Behavioral Therapy
|
|---|---|---|
|
Clinical Global Impression Scales for Severity and Improvement
CGI-I Baseline
|
3.3 units on a scale
Standard Deviation 1.6
|
2.7 units on a scale
Standard Deviation 1.9
|
|
Clinical Global Impression Scales for Severity and Improvement
CGI-S Baseline
|
4.1 units on a scale
Standard Deviation 0.5
|
4.3 units on a scale
Standard Deviation 0.5
|
|
Clinical Global Impression Scales for Severity and Improvement
CGI-S LOCF
|
2.5 units on a scale
Standard Deviation 1.2
|
2.9 units on a scale
Standard Deviation 1.2
|
|
Clinical Global Impression Scales for Severity and Improvement
CGI-I LOCF
|
1.8 units on a scale
Standard Deviation 1.0
|
2.4 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: baseline and week 16Changes in Sexual Functioning Questionnaire (CSFQ) at week 16 as compared to baseline. The CSFQ assesses interest, functioning, and satisfaction in sex on a six-point scale, where 1 is greater than normal and 6 is totally absent, with full range from 5 (greater than normal) to 30 (totally absent).
Outcome measures
| Measure |
Seroquel XR Plus CBT
n=26 Participants
Participants were required to take a minimum of one 50 mg pill of quetiapine XR a day.
|
Placebo Plus CBT
n=29 Participants
matching placebo pills plus 16 weeks of Cognitive Behavioral Therapy
|
|---|---|---|
|
Changes in Sexual Functioning Questionnaire (CSFQ)
Baseline
|
15.1 units on a scale
Standard Deviation 6.3
|
16.6 units on a scale
Standard Deviation 5.7
|
|
Changes in Sexual Functioning Questionnaire (CSFQ)
LOCF
|
1.8 units on a scale
Standard Deviation 0.9
|
14.1 units on a scale
Standard Deviation 6.5
|
Adverse Events
Seroquel XR Plus CBT
Placebo Plus CBT
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Seroquel XR Plus CBT
n=26 participants at risk
Participants were required to take a minimum of one 50 mg pill of quetiapine XR a day.
|
Placebo Plus CBT
n=29 participants at risk
matching placebo pills plus 16 weeks of Cognitive Behavioral Therapy
|
|---|---|---|
|
Psychiatric disorders
depression
|
3.8%
1/26
|
0.00%
0/29
|
|
Blood and lymphatic system disorders
Blood clot
|
3.8%
1/26
|
0.00%
0/29
|
|
Nervous system disorders
Sedation
|
92.3%
24/26
|
37.9%
11/29
|
Additional Information
Cindy J. Aaronson, MSW, PhD
Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place