Trial Outcomes & Findings for Melancholic Depression and Insomnia as Predictors of Response to Quetiapine in Patients With Major Depression (NCT NCT03207438)
NCT ID: NCT03207438
Last Updated: 2019-12-04
Results Overview
MADRS is the Montgomery-Asberg Depression Rating Scale. Total scores on this scale range from 0-60. However the response variable is binary coded (0 = No Response, 1 = Response).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1790 participants
Primary outcome timeframe
1 - 6 weeks
Results posted on
2019-12-04
Participant Flow
We estimated the total sample size prior to accessing the data. However, not every participant consented to have their information used/shared with researchers. Therefore the analyzed sample, consisting of only those who consented, is slightly reduced compared to the sum of the sample sizes reported in the original study reports.
Participant milestones
| Measure |
Quetiapine XR 50mg
Quetiapine XR 50mg OD for 6 weeks
Quetiapine 50 MG Extended Release Oral Tablet: OD
|
Placebo 1
Placebo OD for 6 weeks
Placebos: Placebo
|
Quetiapine XR 150-300mg
Quetiapine XR 150-300mg OD for 6 weeks
Quetiapine Fumarate XR 150-300 mg: Dose ranged from 150 to 300mg, XR preparation, OD
|
Placebo 2
Placebo OD for 6 weeks
Placebos: Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
167
|
166
|
875
|
582
|
|
Overall Study
COMPLETED
|
148
|
145
|
643
|
470
|
|
Overall Study
NOT COMPLETED
|
19
|
21
|
232
|
112
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Quetiapine XR 50mg
n=167 Participants
Quetiapine XR 50mg OD for 6 weeks
Quetiapine 50 MG Extended Release Oral Tablet: OD
|
Placebo 1
n=166 Participants
Placebo OD for 6 weeks
Placebos: Placebo
|
Quetiapine XR 150-300mg
n=875 Participants
Quetiapine XR 150-300mg OD for 6 weeks
Quetiapine Fumarate XR 150-300 mg: Dose ranged from 150 to 300mg, XR preparation, OD
|
Placebo 2
n=582 Participants
Placebo OD for 6 weeks
Placebos: Placebo
|
Total
n=1790 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
40.6 years
STANDARD_DEVIATION 11.2 • n=167 Participants
|
40.1 years
STANDARD_DEVIATION 11.8 • n=166 Participants
|
41.5 years
STANDARD_DEVIATION 11.8 • n=875 Participants
|
41.1 years
STANDARD_DEVIATION 11.6 • n=582 Participants
|
41.1 years
STANDARD_DEVIATION 11.7 • n=1790 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=167 Participants
|
107 Participants
n=166 Participants
|
543 Participants
n=875 Participants
|
380 Participants
n=582 Participants
|
1119 Participants
n=1790 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=167 Participants
|
59 Participants
n=166 Participants
|
332 Participants
n=875 Participants
|
202 Participants
n=582 Participants
|
671 Participants
n=1790 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Montgomery-Åsberg Depression Rating Scale score
|
30.9 units on a scale
STANDARD_DEVIATION 4.61 • n=167 Participants
|
30.4 units on a scale
STANDARD_DEVIATION 5.21 • n=166 Participants
|
30.6 units on a scale
STANDARD_DEVIATION 5.44 • n=875 Participants
|
30.4 units on a scale
STANDARD_DEVIATION 5.27 • n=582 Participants
|
30.5 units on a scale
STANDARD_DEVIATION 5.14 • n=1790 Participants
|
PRIMARY outcome
Timeframe: 1 - 6 weeksPopulation: See the number analyzed below. It decreases as the study week advances due to censoring.
MADRS is the Montgomery-Asberg Depression Rating Scale. Total scores on this scale range from 0-60. However the response variable is binary coded (0 = No Response, 1 = Response).
Outcome measures
| Measure |
Quetiapine XR 150-300mg - Melancholic Depression
n=283 Participants
Quetiapine XR 150-300mg OD for 6 weeks
Quetiapine Fumarate XR 150-300 mg: Dose ranged from 150 to 300mg, XR preparation, OD
|
Placebo 2 - Melancholic Depression
n=179 Participants
Placebo OD for 6 weeks (vs. Quetiapine XR 150-300 mg/day)
Placebos: Placebo
|
Quetiapine XR 150-300mg - Nonmelancholic Depression
n=592 Participants
Quetiapine XR 150-300mg OD for 6 weeks
Quetiapine Fumarate XR 150-300 mg: Dose ranged from 150 to 300mg, XR preparation, OD
|
Placebo 2 - Nonmelancholic Depression
n=403 Participants
Placebo OD for 6 weeks (vs. Quetiapine XR 150-300 mg/day)
Placebos: Placebo
|
|---|---|---|---|---|
|
Number of Participants With 50 Percent Or Greater Reduction in the MADRS Score Over Time for the Quetiapine XR 150-300mg and Placebo 2 Arms/Groups Stratified by Depression Type (Melancholic vs. Nonmelancholic)
Week 2
|
105 Participants
|
41 Participants
|
195 Participants
|
100 Participants
|
|
Number of Participants With 50 Percent Or Greater Reduction in the MADRS Score Over Time for the Quetiapine XR 150-300mg and Placebo 2 Arms/Groups Stratified by Depression Type (Melancholic vs. Nonmelancholic)
Week 4
|
124 Participants
|
62 Participants
|
251 Participants
|
136 Participants
|
|
Number of Participants With 50 Percent Or Greater Reduction in the MADRS Score Over Time for the Quetiapine XR 150-300mg and Placebo 2 Arms/Groups Stratified by Depression Type (Melancholic vs. Nonmelancholic)
Week 6
|
141 Participants
|
64 Participants
|
274 Participants
|
174 Participants
|
|
Number of Participants With 50 Percent Or Greater Reduction in the MADRS Score Over Time for the Quetiapine XR 150-300mg and Placebo 2 Arms/Groups Stratified by Depression Type (Melancholic vs. Nonmelancholic)
Week 1
|
63 Participants
|
28 Participants
|
86 Participants
|
47 Participants
|
PRIMARY outcome
Timeframe: 1 - 6 weeksPopulation: See the number analyzed below. It decreases as study week advances due to censoring.
50% score reduction from baseline calculated without Item 4 (reduced sleep).
Outcome measures
| Measure |
Quetiapine XR 150-300mg - Melancholic Depression
n=283 Participants
Quetiapine XR 150-300mg OD for 6 weeks
Quetiapine Fumarate XR 150-300 mg: Dose ranged from 150 to 300mg, XR preparation, OD
|
Placebo 2 - Melancholic Depression
n=179 Participants
Placebo OD for 6 weeks (vs. Quetiapine XR 150-300 mg/day)
Placebos: Placebo
|
Quetiapine XR 150-300mg - Nonmelancholic Depression
n=592 Participants
Quetiapine XR 150-300mg OD for 6 weeks
Quetiapine Fumarate XR 150-300 mg: Dose ranged from 150 to 300mg, XR preparation, OD
|
Placebo 2 - Nonmelancholic Depression
n=403 Participants
Placebo OD for 6 weeks (vs. Quetiapine XR 150-300 mg/day)
Placebos: Placebo
|
|---|---|---|---|---|
|
Modified MADRS Response Rates
Week 1
|
53 Participants
|
26 Participants
|
68 Participants
|
46 Participants
|
|
Modified MADRS Response Rates
Week 2
|
90 Participants
|
45 Participants
|
179 Participants
|
100 Participants
|
|
Modified MADRS Response Rates
Week 4
|
124 Participants
|
61 Participants
|
231 Participants
|
136 Participants
|
|
Modified MADRS Response Rates
Week 6
|
132 Participants
|
64 Participants
|
260 Participants
|
176 Participants
|
PRIMARY outcome
Timeframe: Day 4 - Week 6Population: Sample was split by the presence of baseline insomnia and treatment randomization
Defined as a 50% score reduction from baseline.
Outcome measures
| Measure |
Quetiapine XR 150-300mg - Melancholic Depression
n=146 Participants
Quetiapine XR 150-300mg OD for 6 weeks
Quetiapine Fumarate XR 150-300 mg: Dose ranged from 150 to 300mg, XR preparation, OD
|
Placebo 2 - Melancholic Depression
n=149 Participants
Placebo OD for 6 weeks (vs. Quetiapine XR 150-300 mg/day)
Placebos: Placebo
|
Quetiapine XR 150-300mg - Nonmelancholic Depression
n=21 Participants
Quetiapine XR 150-300mg OD for 6 weeks
Quetiapine Fumarate XR 150-300 mg: Dose ranged from 150 to 300mg, XR preparation, OD
|
Placebo 2 - Nonmelancholic Depression
n=17 Participants
Placebo OD for 6 weeks (vs. Quetiapine XR 150-300 mg/day)
Placebos: Placebo
|
|---|---|---|---|---|
|
MADRS Response Rates
Week 6
|
64 Participants
|
45 Participants
|
9 Participants
|
5 Participants
|
|
MADRS Response Rates
Day 4
|
8 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
|
MADRS Response Rates
Week 1
|
26 Participants
|
12 Participants
|
3 Participants
|
1 Participants
|
|
MADRS Response Rates
Week 2
|
42 Participants
|
31 Participants
|
8 Participants
|
1 Participants
|
|
MADRS Response Rates
Week 4
|
59 Participants
|
44 Participants
|
5 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Day 4 - Week 6Calculated without Item 4 (reduced sleep).
Outcome measures
| Measure |
Quetiapine XR 150-300mg - Melancholic Depression
n=167 Participants
Quetiapine XR 150-300mg OD for 6 weeks
Quetiapine Fumarate XR 150-300 mg: Dose ranged from 150 to 300mg, XR preparation, OD
|
Placebo 2 - Melancholic Depression
n=166 Participants
Placebo OD for 6 weeks (vs. Quetiapine XR 150-300 mg/day)
Placebos: Placebo
|
Quetiapine XR 150-300mg - Nonmelancholic Depression
Quetiapine XR 150-300mg OD for 6 weeks
Quetiapine Fumarate XR 150-300 mg: Dose ranged from 150 to 300mg, XR preparation, OD
|
Placebo 2 - Nonmelancholic Depression
Placebo OD for 6 weeks (vs. Quetiapine XR 150-300 mg/day)
Placebos: Placebo
|
|---|---|---|---|---|
|
Modified MADRS Response Rate
Day 4
|
6 Participants
|
6 Participants
|
—
|
—
|
|
Modified MADRS Response Rate
Week 1
|
22 Participants
|
11 Participants
|
—
|
—
|
|
Modified MADRS Response Rate
Week 2
|
44 Participants
|
28 Participants
|
—
|
—
|
|
Modified MADRS Response Rate
Week 4
|
57 Participants
|
49 Participants
|
—
|
—
|
|
Modified MADRS Response Rate
Week 6
|
66 Participants
|
51 Participants
|
—
|
—
|
Adverse Events
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60