Improving Treatment Outcomes in Pharmacotherapy of Generalized Social Anxiety Disorder
Condition: Social Phobia
MeSH terms: Anxiety Disorders; Phobic Disorders; Phobia, Social
Intervention: Sertraline; Venlafaxine; Placebo; Clonazepam
Intervention MeSH terms: Clonazepam; Sertraline; Venlafaxine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 397.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Social Anxiety Disorder; Pharmacotherapy; Genetics; Treatment Refractory

Summary:

      This study will compare the effectiveness of either adding clonazepam or placebo to standard
      treatment or switching to venlafaxine in treating generalized social anxiety disorder in
      individuals who have not responded to treatment with sertraline.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary psychiatric diagnosis of GSAD as defined by DSM-IV criteria and a score above
             60 on the LSAS

          -  Agrees to use an effective form of contraception throughout the study

        Exclusion Criteria:

          -  Clinically significant abnormalities found upon physical examination,
             electrocardiogram, and laboratory tests

          -  History of more than two unsuccessful, adequate treatment trials, indicated by a lack
             of response to over 10 weeks of any of the following: SSRIs (e.g., 40 mg of paroxetine
             or its equivalent per day); benzodiazepine (e.g. at least 2.5 mg of clonazepam per
             day) plus antidepressant (adequate dose as above); monoamine oxidase inhibitors (e.g.,
             60 mg of phenelzine or its equivalent per day); or a single failed trial of over 10
             weeks of venlafaxine ( at least 150 mg per day)

          -  Pregnant or breastfeeding

          -  Simultaneous use of other psychotropic medications, with the exception of
             psychostimulants to treat ADHD; participants must discontinue regular benzodiazepine
             or antidepressant therapy at least two weeks (5 weeks for fluoxetine) prior to study
             entry; beta-blockers must be discontinued unless they are indicated medically (e.g.,
             for hypertension)

          -  DSM-IV diagnosis of any of the following: lifetime history of schizophrenia or any
             other psychosis, mental retardation, organic medical disorder, bipolar disorder, or
             obsessive compulsive disorder; eating disorder in the past 6 months; alcohol or
             substance abuse in the past 3 months or dependence within the past 6 months (entry of
             participants with major depression, dysthymia, panic disorder, generalized anxiety
             disorder, or post-traumatic stress disorder will be permitted if the social anxiety
             disorder is judged to be the predominant disorder)

          -  Significant suicidal ideation as indicated by a score greater than 3 on the
             Montgomery-Asberg Depression Rating Scale or suicidal behaviors within 6 months prior
             to study entry

          -  Significant personality dysfunction that could interfere with study participation

          -  Serious medical illness or instability for which hospitalization may be likely during
             the study

          -  Seizure disorders, with the exception of a childhood history of isolated,
             non-recurrent febrile seizures

          -  Any concurrent psychotherapy initiated within 3 months of study entry, or ongoing
             psychotherapy of any duration directed specifically toward treatment of GSAD
             (prohibited psychotherapy includes cognitive behavioral therapy or psychodynamic
             therapy that focuses on exploring specific, dynamic causes of the phobic
             symptomatology and that provides management skills; general supportive therapy for
             more than 3 months is acceptable)