Trial Outcomes & Findings for A Study of Quetiapine SR (Seroquel SR) to Treat SSRI-Resistant, Comorbid Panic Disorder Patients (NCT NCT00619892)
NCT ID: NCT00619892
Last Updated: 2016-01-21
Results Overview
Possible total scores on the PDSS range from 0-28. The outcome measure represents the change, between baseline and the end of 8 weeks of treatment, in the the total PDSS scores. Lower scores indicate less severe panic disorder symptoms. A negative mean change in the scores at the end of 8 weeks represents a decrease in severity of panic disorder symptoms.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
26 participants
Primary outcome timeframe
Baseline and the end of 8 weeks of treatment
Results posted on
2016-01-21
Participant Flow
Participant milestones
| Measure |
Quetiapine SR
quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
|
Placebo
placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
10
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Quetiapine SR
quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
|
Placebo
placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Intercurrent illness
|
0
|
1
|
Baseline Characteristics
A Study of Quetiapine SR (Seroquel SR) to Treat SSRI-Resistant, Comorbid Panic Disorder Patients
Baseline characteristics by cohort
| Measure |
Quetiapine
n=13 Participants
Quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
|
Placebo
n=13 Participants
Placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
|
Total
n=26 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
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 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 9.6 • n=5 Participants
|
35.5 years
STANDARD_DEVIATION 16.8 • n=7 Participants
|
35.5 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Panic Disorder Severity Scale
|
14.8 units on a scale
STANDARD_DEVIATION 3.6 • n=5 Participants
|
13.7 units on a scale
STANDARD_DEVIATION 3 • n=7 Participants
|
14.3 units on a scale
STANDARD_DEVIATION 3.3 • n=5 Participants
|
|
Clinical Global Impression-Severity Scale (CGI-S)
|
4.8 units on a scale
STANDARD_DEVIATION 0.8 • n=5 Participants
|
4.4 units on a scale
STANDARD_DEVIATION 0.7 • n=7 Participants
|
4.6 units on a scale
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Hamilton Anxiety Rating Scale (HAM-A)
|
21.2 units on a scale
STANDARD_DEVIATION 6.8 • n=5 Participants
|
17 units on a scale
STANDARD_DEVIATION 5.2 • n=7 Participants
|
19.1 units on a scale
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
Hamilton Depression Rating Scale (HAM-D)
|
14.6 units on a scale
STANDARD_DEVIATION 6.2 • n=5 Participants
|
11.5 units on a scale
STANDARD_DEVIATION 5.1 • n=7 Participants
|
13.1 units on a scale
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Pittsburgh Sleep Quality Index (PSQI) sleep hours
|
6.2 hours slept per night
STANDARD_DEVIATION 1.3 • n=5 Participants
|
6.7 hours slept per night
STANDARD_DEVIATION 1.6 • n=7 Participants
|
6.5 hours slept per night
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Pittsburgh Sleep Quality Index (PSQI) sleep quality
|
2.9 units on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
|
2.3 units on a scale
STANDARD_DEVIATION 0.6 • n=7 Participants
|
2.6 units on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and the end of 8 weeks of treatmentPossible total scores on the PDSS range from 0-28. The outcome measure represents the change, between baseline and the end of 8 weeks of treatment, in the the total PDSS scores. Lower scores indicate less severe panic disorder symptoms. A negative mean change in the scores at the end of 8 weeks represents a decrease in severity of panic disorder symptoms.
Outcome measures
| Measure |
Quetiapine SR
n=13 Participants
quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
|
Placebo
n=13 Participants
placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
|
|---|---|---|
|
Change in Mean Total Panic Disorder Severity Scale (PDSS) Scores
|
-5.3 units on a scale
Standard Deviation 4.7
|
-5.6 units on a scale
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: Comparing baseline and the end of 8 weeks of treatmentSubjects scores on secondary efficacy measures were measured, comparing baseline and the end of 8 weeks of treatment, including the Hamilton Depression Rating Scale, HAM-D, which has 21 items, with scores ranging from 0-66; the Hamilton Anxiety Rating Scale, HAM-A, which has 14 items, with scores ranging from 0-56; and the sleep quality item of the PSQI, a four-point scale rating sleep quality as very good, fairly good, fairly bad or very bad.
Outcome measures
| Measure |
Quetiapine SR
n=13 Participants
quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
|
Placebo
n=13 Participants
placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
|
|---|---|---|
|
Change in Scores in Measurements of Depressive Symptoms (Hamilton Depression Rating Scale, HAM-D), Generalized Anxiety Symptoms (Hamilton Anxiety Rating Scale, HAM-A) and the Sleep Quality Item of the Pittsburgh Sleep Quality Index (PSQI).
Decrease in HAM-D scores
|
5.0 units on a scale
Standard Deviation 5.2
|
3.8 units on a scale
Standard Deviation 3.6
|
|
Change in Scores in Measurements of Depressive Symptoms (Hamilton Depression Rating Scale, HAM-D), Generalized Anxiety Symptoms (Hamilton Anxiety Rating Scale, HAM-A) and the Sleep Quality Item of the Pittsburgh Sleep Quality Index (PSQI).
Decrease in HAM-A scores
|
6.8 units on a scale
Standard Deviation 8.1
|
5.5 units on a scale
Standard Deviation 4.7
|
|
Change in Scores in Measurements of Depressive Symptoms (Hamilton Depression Rating Scale, HAM-D), Generalized Anxiety Symptoms (Hamilton Anxiety Rating Scale, HAM-A) and the Sleep Quality Item of the Pittsburgh Sleep Quality Index (PSQI).
Increase in PSQI sleep quality scores
|
1.3 units on a scale
Standard Deviation 0.5
|
1.3 units on a scale
Standard Deviation 1.0
|
Adverse Events
Quietapine Group
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo Group
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Quietapine Group
n=13 participants at risk
quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
|
Placebo Group
n=13 participants at risk
placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
|
|---|---|---|
|
Nervous system disorders
Shakiness
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
|
Musculoskeletal and connective tissue disorders
Muscle Aches
|
0.00%
0/13
|
15.4%
2/13 • Number of events 2
|
|
Gastrointestinal disorders
Weight Gain
|
0.00%
0/13
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Somnolence
|
76.9%
10/13 • Number of events 10
|
38.5%
5/13 • Number of events 5
|
|
Psychiatric disorders
Anxiety
|
30.8%
4/13 • Number of events 4
|
0.00%
0/13
|
|
Gastrointestinal disorders
Constipation
|
23.1%
3/13 • Number of events 3
|
7.7%
1/13 • Number of events 1
|
|
Nervous system disorders
Dry Mouth
|
23.1%
3/13 • Number of events 3
|
0.00%
0/13
|
|
Nervous system disorders
Dizziness
|
15.4%
2/13 • Number of events 2
|
23.1%
3/13 • Number of events 3
|
|
Nervous system disorders
Restlessness
|
15.4%
2/13 • Number of events 2
|
30.8%
4/13 • Number of events 4
|
|
Psychiatric disorders
Derealization
|
15.4%
2/13 • Number of events 2
|
0.00%
0/13
|
|
Nervous system disorders
Insomnia
|
7.7%
1/13 • Number of events 1
|
23.1%
3/13 • Number of events 3
|
|
Nervous system disorders
Increased Appetite
|
7.7%
1/13 • Number of events 1
|
15.4%
2/13 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Leg Pain
|
7.7%
1/13 • Number of events 1
|
7.7%
1/13 • Number of events 1
|
|
Gastrointestinal disorders
Weight Loss
|
7.7%
1/13 • Number of events 1
|
0.00%
0/13
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place