Trial Outcomes & Findings for Quetiapine Sr as Adjunctive Treatment In Mixed States of Bipolar Disorder (NCT NCT01195363)
NCT ID: NCT01195363
Last Updated: 2017-03-23
Results Overview
The primary outcome measure was assessed by 50% reduction in: 1. depression scores on the Montgomery Asberg Depression Rating Scale (MADRS), which ranges from 0 indicating no symptoms to 60 indicating most symptoms 2. mania scores on the Young Mania Rating Scale (YMRS), which ranges from 0 indicating no symptoms to 60 indicating most symptoms.
COMPLETED
PHASE4
28 participants
Baseline visit to week 24
2017-03-23
Participant Flow
Participants were recruited in our University, Center for Healthcare Services, and by televison ads between Oct 2007 and January 2011.
Patients screened over a 7 day period.
Participant milestones
| Measure |
Quetiapine SR, 200-600mg , po, QD
mood stabilizer plus active quetiapine SR
|
Quetiapine sr Placebo 200-600mg, po, qd
mood stabilizer plus quetiapine SR placebo
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
13
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
11
|
9
|
Reasons for withdrawal
| Measure |
Quetiapine SR, 200-600mg , po, QD
mood stabilizer plus active quetiapine SR
|
Quetiapine sr Placebo 200-600mg, po, qd
mood stabilizer plus quetiapine SR placebo
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
4
|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Lack of Efficacy
|
0
|
4
|
|
Overall Study
incarceration
|
1
|
0
|
Baseline Characteristics
Quetiapine Sr as Adjunctive Treatment In Mixed States of Bipolar Disorder
Baseline characteristics by cohort
| Measure |
Active Quetiapine SR
n=15 Participants
mood stabilizer plus active quetiapine sr
|
Quetiapine SR Placebo
n=13 Participants
mood stabilizer plus quetiapine SR placebo
|
Total
n=28 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
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 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
|
35.5 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
32.1 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
34 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
13 participants
n=7 Participants
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline visit to week 24Population: Per Protocol
The primary outcome measure was assessed by 50% reduction in: 1. depression scores on the Montgomery Asberg Depression Rating Scale (MADRS), which ranges from 0 indicating no symptoms to 60 indicating most symptoms 2. mania scores on the Young Mania Rating Scale (YMRS), which ranges from 0 indicating no symptoms to 60 indicating most symptoms.
Outcome measures
| Measure |
Active Quetiapine S.R., 200-600mg, po, qd
n=15 Participants
Atypical antipsychotic quetiapine S.R. plus mood stabilizer
|
Placebo Quetiapine S.R. 200-600mg, po, qd
n=13 Participants
mood stabilizer plus quetiapine S.R. placebo
|
|---|---|---|
|
Number of Patients Whose Mood Improved According to MADRS and YMRS Scale Scores.
MADRS
|
4 participants
|
4 participants
|
|
Number of Patients Whose Mood Improved According to MADRS and YMRS Scale Scores.
YMRS
|
4 participants
|
4 participants
|
Adverse Events
Mood Stabilizer Plus Quetiapine SR
Mood Stabilizer Plus Quetiapine sr Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mood Stabilizer Plus Quetiapine SR
n=15 participants at risk
mood stabilizer plus active quetiapine SR
|
Mood Stabilizer Plus Quetiapine sr Placebo
n=13 participants at risk
mood stabilizer plus quetiapine SR placebo
|
|---|---|---|
|
General disorders
dry mouth
|
26.7%
4/15 • Number of events 4 • 10/30/2007 - 6/1/2011, 2 yrs 8 mos.
|
15.4%
2/13 • Number of events 2 • 10/30/2007 - 6/1/2011, 2 yrs 8 mos.
|
|
General disorders
joint pain
|
13.3%
2/15 • Number of events 2 • 10/30/2007 - 6/1/2011, 2 yrs 8 mos.
|
0.00%
0/13 • 10/30/2007 - 6/1/2011, 2 yrs 8 mos.
|
|
Investigations
drowsiness/sedation
|
46.7%
7/15 • Number of events 7 • 10/30/2007 - 6/1/2011, 2 yrs 8 mos.
|
23.1%
3/13 • Number of events 3 • 10/30/2007 - 6/1/2011, 2 yrs 8 mos.
|
|
Investigations
interrupted sleep
|
13.3%
2/15 • Number of events 2 • 10/30/2007 - 6/1/2011, 2 yrs 8 mos.
|
0.00%
0/13 • 10/30/2007 - 6/1/2011, 2 yrs 8 mos.
|
|
Musculoskeletal and connective tissue disorders
muscle weakness
|
13.3%
2/15 • Number of events 2 • 10/30/2007 - 6/1/2011, 2 yrs 8 mos.
|
0.00%
0/13 • 10/30/2007 - 6/1/2011, 2 yrs 8 mos.
|
|
Gastrointestinal disorders
nausea
|
13.3%
2/15 • Number of events 2 • 10/30/2007 - 6/1/2011, 2 yrs 8 mos.
|
0.00%
0/13 • 10/30/2007 - 6/1/2011, 2 yrs 8 mos.
|
|
General disorders
headache
|
6.7%
1/15 • Number of events 1 • 10/30/2007 - 6/1/2011, 2 yrs 8 mos.
|
15.4%
2/13 • Number of events 2 • 10/30/2007 - 6/1/2011, 2 yrs 8 mos.
|
|
Metabolism and nutrition disorders
increased appetite
|
6.7%
1/15 • Number of events 1 • 10/30/2007 - 6/1/2011, 2 yrs 8 mos.
|
15.4%
2/13 • Number of events 2 • 10/30/2007 - 6/1/2011, 2 yrs 8 mos.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place