Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism
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ClinicalTrials.gov Identifier: NCT00246441 |
Recruitment Status :
Completed
First Posted : October 30, 2005
Results First Posted : September 27, 2018
Last Update Posted : September 27, 2018
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Sponsor:
Medical University of South Carolina
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Medical University of South Carolina
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
Conditions |
Social Anxiety Disorder Social Phobia Alcohol Use Disorder Alcohol Abuse Alcohol Dependence |
Interventions |
Drug: Paroxetine Drug: Placebo |
Enrollment | 42 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Paroxetine | Placebo |
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Paroxetine Paroxetine: 16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day |
Placebo Placebo: treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day. |
Period Title: Overall Study | ||
Started | 20 | 22 |
Completed | 19 | 22 |
Not Completed | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Paroxetine | Placebo | Total | |
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Paroxetine Paroxetine: 16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day |
Placebo Placebo: treatment phase will last 16 weeks; dosing will start at 20 mg/day (placebo) and will increase gradually to a maximum dose of 60 mg/day. |
Total of all reporting groups | |
Overall Number of Baseline Participants | 20 | 22 | 42 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 20 participants | 22 participants | 42 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
20 100.0%
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22 100.0%
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42 100.0%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 20 participants | 22 participants | 42 participants | |
28 (6.5) | 30 (8.3) | 29 (7.4) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 20 participants | 22 participants | 42 participants | |
Female |
9 45.0%
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11 50.0%
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20 47.6%
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Male |
11 55.0%
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11 50.0%
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22 52.4%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 20 participants | 22 participants | 42 participants |
20 | 22 | 42 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Dr. Sarah Book |
Organization: | MUSC |
Phone: | 8437925200 |
EMail: | booksw@musc.edu |
Responsible Party: | Medical University of South Carolina |
ClinicalTrials.gov Identifier: | NCT00246441 |
Other Study ID Numbers: |
NIAAARAN013379 R01AA013379 ( U.S. NIH Grant/Contract ) |
First Submitted: | October 28, 2005 |
First Posted: | October 30, 2005 |
Results First Submitted: | July 23, 2018 |
Results First Posted: | September 27, 2018 |
Last Update Posted: | September 27, 2018 |