The Effects of Quetiapine (Seroquel XR) on Sleep During Alcohol Abstinence
The Effects of Quetiapine on Sleep During Alcohol Abstinence
1 other identifier
interventional
22
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2007
CompletedFirst Posted
Study publicly available on registry
February 14, 2007
CompletedStudy Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
August 9, 2013
CompletedAugust 9, 2013
July 1, 2013
2.3 years
February 12, 2007
May 16, 2013
July 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sleep Efficiency (From an In-laboratory Polysomnogram)
The fraction of time spent asleep to the total time in bed (%).
Baseline, and week 8 of treatment.
Secondary Outcomes (3)
Insomnia Severity Index (ISI)
Baseline, weeks 1, 3, 5, and 7 of treatment.
Pittsburgh Sleep Quality Index (PSQI)
Baseline, weeks 4, and 9.
Wake After Sleep Onset Time (WASO) From an In-laboratory Polysomnogram.
Baseline, and week 8
Study Arms (2)
1
EXPERIMENTALQuetiapine XR
2
PLACEBO COMPARATORPlacebo
Interventions
Quetiapine is a second generation antipsychotic medication, which has also recently shown to be associated with properties of mood stabilization in bipolar disorder.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Philadelphia, OPC
Philadelphia, Pennsylvania, 19106, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The limitations of this study include the small sample size, and assessment of PSQI, PHQ-9, BAI, and SF-12 at week 9 (immediately after washout from the study drug). The corruption of stored online actigraphic sleep data prevented its interpretation.
Results Point of Contact
- Title
- Subhajit Chakravorty
- Organization
- Philadelphia VAMC
Study Officials
- PRINCIPAL INVESTIGATOR
Subhajit Chakravorty, MD
Philadelphia, OPC
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Staff Physician
Study Record Dates
First Submitted
February 12, 2007
First Posted
February 14, 2007
Study Start
August 1, 2007
Primary Completion
November 1, 2009
Study Completion
December 1, 2009
Last Updated
August 9, 2013
Results First Posted
August 9, 2013
Record last verified: 2013-07