Trial Outcomes & Findings for The Effects of Quetiapine (Seroquel XR) on Sleep During Alcohol Abstinence (NCT NCT00434876)
NCT ID: NCT00434876
Last Updated: 2013-08-09
Results Overview
The fraction of time spent asleep to the total time in bed (%).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
22 participants
Primary outcome timeframe
Baseline, and week 8 of treatment.
Results posted on
2013-08-09
Participant Flow
Addiction psychiatry clinic, behavioral health laboratory, and self referrals solicited through flyers.
Participant milestones
| Measure |
Quetiapine XR
The pills were taken at bedtime and the dose was titrated flexibly in the following fashion over the first week: 50 mg dose for 2 nights, followed by 200 mg a night for 2 nights, and then 300 mg a night for 2 nights and to a final dose of 400 mg daily starting on night # 7. Medication taper commenced at week 8 in the reverse stepwise fashion after the second set of two polysomnograms.
|
Placebo
The matching placebo pills were similarly taken at bedtime and the dose was titrated flexibly in the following fashion over the first week: 50 mg dose for 2 nights, followed by 200 mg a night for 2 nights, and then 300 mg a night for 2 nights and to a final dose of 400 mg daily starting on night # 7. Medication taper commenced at week 8 in the reverse stepwise fashion after the second set of two polysomnograms.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Quetiapine XR
The pills were taken at bedtime and the dose was titrated flexibly in the following fashion over the first week: 50 mg dose for 2 nights, followed by 200 mg a night for 2 nights, and then 300 mg a night for 2 nights and to a final dose of 400 mg daily starting on night # 7. Medication taper commenced at week 8 in the reverse stepwise fashion after the second set of two polysomnograms.
|
Placebo
The matching placebo pills were similarly taken at bedtime and the dose was titrated flexibly in the following fashion over the first week: 50 mg dose for 2 nights, followed by 200 mg a night for 2 nights, and then 300 mg a night for 2 nights and to a final dose of 400 mg daily starting on night # 7. Medication taper commenced at week 8 in the reverse stepwise fashion after the second set of two polysomnograms.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
The Effects of Quetiapine (Seroquel XR) on Sleep During Alcohol Abstinence
Baseline characteristics by cohort
| Measure |
Quetiapine
n=10 Participants
Quetiapine XR
|
Placebo
n=10 Participants
Placebo
|
Total
n=20 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
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 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
|
53 years
STANDARD_DEVIATION 6 • n=5 Participants
|
51 years
STANDARD_DEVIATION 8 • n=7 Participants
|
52 years
STANDARD_DEVIATION 7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, and week 8 of treatment.The fraction of time spent asleep to the total time in bed (%).
Outcome measures
| Measure |
Quetiapine XR
n=10 Participants
Quetiapine XR
|
Placebo
n=10 Participants
Placebo
|
|---|---|---|
|
Sleep Efficiency (From an In-laboratory Polysomnogram)
Sleep Efficiency (baseline)
|
70.70 percentage
Standard Deviation 17.49
|
78.63 percentage
Standard Deviation 12.89
|
|
Sleep Efficiency (From an In-laboratory Polysomnogram)
Sleep Efficiency (after 8 weeks of treatment)
|
79.45 percentage
Standard Deviation 16.52
|
82.80 percentage
Standard Deviation 11.57
|
SECONDARY outcome
Timeframe: Baseline, weeks 1, 3, 5, and 7 of treatment.ISI total score; this scale assesses for global insomnia severity (range 0-24). Higher scale scores indicate higher insomnia severity.
Outcome measures
| Measure |
Quetiapine XR
n=10 Participants
Quetiapine XR
|
Placebo
n=10 Participants
Placebo
|
|---|---|---|
|
Insomnia Severity Index (ISI)
ISI (baseline)
|
17.00 units on a scale
Standard Deviation 4.08
|
14.80 units on a scale
Standard Deviation 7.14
|
|
Insomnia Severity Index (ISI)
ISI (week 7)
|
5.40 units on a scale
Standard Deviation 4.83
|
6.70 units on a scale
Standard Deviation 7.34
|
SECONDARY outcome
Timeframe: Baseline, weeks 4, and 9.PSQI total score (range 0-21). A PSQI total score \> 5 indicates insomnia, with higher scores denoting a decrease in sleep quality. The PSQI global score assesses for the overall quality of sleep and is computed by adding the 7 component scale scores. This widely used 19-item self-rated scale evaluates the subjective quality of sleep over the last 4 weeks. The PSQI was administered at baseline, and weeks 4, and 9.
Outcome measures
| Measure |
Quetiapine XR
n=10 Participants
Quetiapine XR
|
Placebo
n=10 Participants
Placebo
|
|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI)
PSQI (baseline)
|
14.70 units on a scale
Standard Deviation 1.94
|
14.60 units on a scale
Standard Deviation 1.71
|
|
Pittsburgh Sleep Quality Index (PSQI)
PSQI (week 4)
|
13.20 units on a scale
Standard Deviation 2.61
|
13.80 units on a scale
Standard Deviation 2.04
|
|
Pittsburgh Sleep Quality Index (PSQI)
PSQI (week 9)
|
14.50 units on a scale
Standard Deviation 2.56
|
13.80 units on a scale
Standard Deviation 2.78
|
SECONDARY outcome
Timeframe: Baseline, and week 8The amount of time spent awake after initially falling asleep and before final awakening (in minutes). None to a fewer minutes is better (than a higher number of minutes).
Outcome measures
| Measure |
Quetiapine XR
n=10 Participants
Quetiapine XR
|
Placebo
n=10 Participants
Placebo
|
|---|---|---|
|
Wake After Sleep Onset Time (WASO) From an In-laboratory Polysomnogram.
WASO (baseline)
|
101.87 minutes
Standard Deviation 81.80
|
61.17 minutes
Standard Deviation 37.77
|
|
Wake After Sleep Onset Time (WASO) From an In-laboratory Polysomnogram.
WASO (week 8)
|
60.71 minutes
Standard Deviation 71.41
|
66.99 minutes
Standard Deviation 60.62
|
Adverse Events
Quetiapine
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Quetiapine
n=10 participants at risk
Quetiapine XR
|
Placebo
n=10 participants at risk
Placebo
|
|---|---|---|
|
Psychiatric disorders
Suicidal ideation
|
10.0%
1/10 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
|
Psychiatric disorders
Relapse to heavy alcohol use leading to inpatient admission
|
10.0%
1/10 • Number of events 1
|
10.0%
1/10 • Number of events 1
|
Other adverse events
| Measure |
Quetiapine
n=10 participants at risk
Quetiapine XR
|
Placebo
n=10 participants at risk
Placebo
|
|---|---|---|
|
Psychiatric disorders
Somnolence
|
70.0%
7/10
|
30.0%
3/10
|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
2/10
|
0.00%
0/10
|
|
General disorders
Fatigue
|
20.0%
2/10
|
0.00%
0/10
|
|
Psychiatric disorders
Insomnia
|
20.0%
2/10
|
0.00%
0/10
|
|
Psychiatric disorders
Increased apetite
|
10.0%
1/10
|
0.00%
0/10
|
|
Cardiac disorders
Dizziness
|
10.0%
1/10
|
10.0%
1/10
|
|
Musculoskeletal and connective tissue disorders
Somatic pain
|
10.0%
1/10
|
0.00%
0/10
|
|
Psychiatric disorders
Agitation
|
10.0%
1/10
|
0.00%
0/10
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10
|
0.00%
0/10
|
|
Psychiatric disorders
Decreased motivation
|
0.00%
0/10
|
10.0%
1/10
|
|
Nervous system disorders
Headache
|
0.00%
0/10
|
10.0%
1/10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place