CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 42 enrolled
Drug / intervention
Paroxetine +1 moredrug
Likely dose
Paroxetine 20 mg/day starting dose, titrated gradually to maximum 60 mg/day over 16 weeksAI-extracted
Key inclusion· 8
  • ✓Meets DSM-IV criteria for current social anxiety disorder, generalized type, with social anxiety in most situations
  • ✓Meets DSM-IV criteria for current alcohol use disorder
  • ✓Reports using alcohol to cope with social anxiety either 'very often' or 'always'
  • ✓Liebowitz Social Anxiety Scale Total score (modified) of at least 60
Key exclusion· 11
  • ✕Abuse or dependence on drugs other than nicotine or marijuana in last 90 days
  • ✕Current or past diagnosis of bipolar disorder or schizophrenia
  • ✕Significant suicide risk as assessed by the SCID
  • ✕Current use of psychotropic medications

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00246441
NCT00246441Phase 4Completed
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Paroxetine for Comorbid Social Anxiety Disorder and Alcoholism

Medical University of South Carolina·interventional·Posted Oct 31, 2005·Updated Sep 27, 2018

In Brief

A Phase 4 clinical trial evaluating Paroxetine and Placebo for Social Anxiety Disorder and 4 related conditions. Completed, enrolled 42 participants across 1 site.

Detailed Summary

The purpose of the study is to determine whether an SSRI, paroxetine, improves social anxiety symptoms and alcohol use in individuals who drink to cope with social anxiety disorder.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSocial Anxiety Disorder, Social Phobia, Alcohol Use Disorder, Alcohol Abuse, Alcohol Dependence
CountriesUnited States
CollaboratorsNational Institute on Alcohol Abuse and Alcoholism (NIAAA)

Timeline

Phase 4CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 31, 2005
Enrollment StartMar 1, 2002
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.9 yearsPosted 20.7 years ago

Interventions

Paroxetinedrug

16 weeks treatment; dosing will start at 20 mg/day paroxetine and will increase gradually to a maximum dose of 60 mg/day

Placebodrug

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.