Trial Outcomes & Findings for Brain Imaging of Quetiapine Response in Anxious Depression (NCT NCT00982345)
NCT ID: NCT00982345
Last Updated: 2016-09-30
Results Overview
Standard 17-item rating scale for depression used in clinical trials. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial. Range of score: 0 - 50.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
20 participants
Primary outcome timeframe
Started: March 2009 Ending March 2011
Results posted on
2016-09-30
Participant Flow
Participant milestones
| Measure |
Seroquel XR
Seroquel XR (quetiapine) starting dose 50 mg and increased up to 400 mg as tolerated) treatment.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Brain Imaging of Quetiapine Response in Anxious Depression
Baseline characteristics by cohort
| Measure |
Quetiapine
n=20 Participants
quetiapine (Seroquel XR) : Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
29 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Started: March 2009 Ending March 2011Standard 17-item rating scale for depression used in clinical trials. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial. Range of score: 0 - 50.
Outcome measures
| Measure |
Quetiapine
n=20 Participants
quetiapine (Seroquel XR) : Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment.
|
|---|---|
|
17-item Hamilton Depression Rating Scale (HDRS)
Baseline 17-item HDRS
|
20 units on a scale
Standard Deviation 3
|
|
17-item Hamilton Depression Rating Scale (HDRS)
Post-treatment at 8 weeks 17-item HDRS
|
8 units on a scale
Standard Deviation 6
|
Adverse Events
Quetiapine
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Quetiapine
n=20 participants at risk
quetiapine (Seroquel XR) : Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment.
|
|---|---|
|
Nervous system disorders
fatigue
|
80.0%
16/20 • Adverse event data were collected for 12 weeks.
|
|
Nervous system disorders
Irritability
|
15.0%
3/20 • Adverse event data were collected for 12 weeks.
|
|
Nervous system disorders
dizziness
|
35.0%
7/20 • Adverse event data were collected for 12 weeks.
|
|
Nervous system disorders
increased sleep
|
75.0%
15/20 • Adverse event data were collected for 12 weeks.
|
|
Nervous system disorders
headache
|
20.0%
4/20 • Adverse event data were collected for 12 weeks.
|
|
Nervous system disorders
dry mouth
|
60.0%
12/20 • Adverse event data were collected for 12 weeks.
|
|
Renal and urinary disorders
urinary frequency
|
10.0%
2/20 • Adverse event data were collected for 12 weeks.
|
|
Nervous system disorders
blurred vision
|
5.0%
1/20 • Adverse event data were collected for 12 weeks.
|
|
Gastrointestinal disorders
indigestion
|
10.0%
2/20 • Adverse event data were collected for 12 weeks.
|
|
Gastrointestinal disorders
constipation
|
30.0%
6/20 • Adverse event data were collected for 12 weeks.
|
|
Gastrointestinal disorders
increased appetite
|
25.0%
5/20 • Adverse event data were collected for 12 weeks.
|
|
Nervous system disorders
decreased sleep
|
10.0%
2/20 • Adverse event data were collected for 12 weeks.
|
|
Gastrointestinal disorders
abdominal pain
|
20.0%
4/20 • Adverse event data were collected for 12 weeks.
|
|
Vascular disorders
fluid retention
|
5.0%
1/20 • Adverse event data were collected for 12 weeks.
|
|
Nervous system disorders
twitching
|
15.0%
3/20 • Adverse event data were collected for 12 weeks.
|
|
Nervous system disorders
sweating
|
10.0%
2/20 • Adverse event data were collected for 12 weeks.
|
|
Skin and subcutaneous tissue disorders
hand dryness
|
5.0%
1/20 • Adverse event data were collected for 12 weeks.
|
|
Gastrointestinal disorders
nausea
|
15.0%
3/20 • Adverse event data were collected for 12 weeks.
|
|
Nervous system disorders
tremor
|
5.0%
1/20 • Adverse event data were collected for 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
5.0%
1/20 • Adverse event data were collected for 12 weeks.
|
|
Gastrointestinal disorders
increased thirst
|
5.0%
1/20 • Adverse event data were collected for 12 weeks.
|
|
Skin and subcutaneous tissue disorders
hives
|
5.0%
1/20 • Adverse event data were collected for 12 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
nose congestion
|
5.0%
1/20 • Adverse event data were collected for 12 weeks.
|
|
Nervous system disorders
fainting
|
5.0%
1/20 • Adverse event data were collected for 12 weeks.
|
|
Gastrointestinal disorders
decreased appetite
|
10.0%
2/20 • Adverse event data were collected for 12 weeks.
|
|
Gastrointestinal disorders
DIARRHEA
|
5.0%
1/20 • Adverse event data were collected for 12 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place