Phase 3
Completed N=22
The Effects of Quetiapine (Seroquel XR) on Sleep During Alcohol Abstinence
Alcoholism · Sleep Initiation and Maintenance Disorders
Source: ClinicalTrials.gov NCT00434876 ↗
Enrolled (actual)
22
Serious AEs
20.0%
Results posted
Aug 2013
Primary outcomePrimary: Sleep Efficiency (From an In-laboratory Polysomnogram) — 70.70; 78.63; 79.45; 82.80 percentage — p=0.49
Summary
The primary purpose of this study is to determine how efficacy of quetiapine (seroquel XR) in improving the sleep in recovering alcohol dependent subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleep Efficiency (From an In-laboratory Polysomnogram) |
70.70; 78.63; 79.45; 82.80 | 0.49 |
| SECONDARY Insomnia Severity Index (ISI) |
17.00; 14.80; 5.40; 6.70 | 0.04 sig |
| SECONDARY Pittsburgh Sleep Quality Index (PSQI) |
14.70; 14.60; 13.20; 13.80; 14.50; 13.80 | 0.57 |
| SECONDARY Wake After Sleep Onset Time (WASO) From an In-laboratory Polysomnogram. |
101.87; 61.17; 60.71; 66.99 | 0.03 sig |
Eligibility Criteria
Inclusion Criteria: subjects between the ages of 18-65 years, with a DSM-IV diagnosis of current alcohol dependence (past year), can speak, understand, and print in English, and is capable of giving written informed consent
Exclusion Criteria: Positive urine drug screen for opioids, cocaine, or amphetamine (excluding THC), dependence on other drugs excluding alcohol/nicotine/cannabis over the past year, unstable psychiatric, medical disorders, cataracts [posterior capsular/ nuclear (grade NS3 or more), currently on any maintenance psychotropic medications affecting sleep, currently pregnant, nursing, or not using a reliable method of contraception; history of hypersensitivity to antipsychotic drugs, including quetiapine, severe cognitive impairment, severe untreated obstructive sleep apnea, and inadequately controlled diabetes mellitus.
Data sourced from ClinicalTrials.gov (NCT00434876). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.