Duloxetine for Social Anxiety Disorder: Prediction of Long Term Outcome
Condition: Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Intervention: Duloxetine; Duloxetine; Placebo
Intervention description: 60 mg duloxetine 1x per day; 60 mg duloxetine 1x per day + 60mg duloxetine 1x per day; 60mg placebo 1x per day
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: social anxiety disorder; social phobia; duloxetine; serotonin norepinephrine reuptake inhibitor; SNRI; double blind

Summary:

      The purpose of this study is to examine the safety and efficacy of duloxetine for the
      treatment of social anxiety disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female outpatients > 18 years of age with a primary psychiatric diagnosis of
             generalized social anxiety disorder as defined by DSM-IV criteria and an LSAS score >
             50.

          -  Physical examination, electrocardiogram, and laboratory findings without clinically
             significant abnormalities.

          -  Willingness and ability to comply with the requirements of the study protocol.

        Exclusion Criteria:

          -  Patient has a history of intolerance or lack of response to a treatment trial of
             duloxetine at highest tolerated dose (<120mg/day).

          -  Patients with acute narrow angle glaucoma.

          -  Pregnant women, lactating women, and women of childbearing potential who are not using
             medically accepted forms of contraception (e.g., IUD, oral contraceptives, barrier
             devices, condoms and foam, or implanted progesterone rods stabilized for at least 3
             months).

          -  Concurrent use of other psychotropic medications. Patients must discontinue regular
             benzodiazepine or antidepressant therapy at least one week (5 weeks for fluoxetine)
             prior to baseline. Concomitant beta-blockers are proscribed unless prescribed for a
             medical indication (e.g., hypertension, at a stable daily dose for > 1 month).

          -  Patients with a history of failure to satisfactorily respond to >2 prior adequate
             treatment trials.

          -  Significant personality dysfunction likely to interfere with study participation.

          -  Serious medical illness or instability for which hospitalization may be likely within
             the next year.

          -  Seizure disorders with the exception of a history of febrile seizures if they occurred
             during childhood, were isolated, and did not recur in adulthood.

          -  Concurrent psychotherapy initiated within 2 months of baseline is prohibited. Ongoing
             psychotherapy of any duration directed specifically toward treatment of the social
             anxiety disorder is excluded. Prohibited psychotherapy includes cognitive behavioral
             therapy or psychodynamic therapy that focuses on exploring specific, dynamic causes of
             the phobic symptomatology and provides skills for their management. General supportive
             individual, couples, or family therapy greater than 2 months duration is acceptable.

          -  Diagnosis of any of the following mental disorders as defined by the DSM-IV: a
             lifetime history of schizophrenia or any other psychosis, mental retardation, organic
             medical disorders or bipolar disorder; eating disorders in the past 6 months; alcohol
             or substance abuse in the past 3 months or dependence within the past 6 months.

          -  Entry of patients with major depression, dysthymia, panic disorder, generalized
             anxiety disorder, post-traumatic stress disorder or obsessive-compulsive disorder will
             be permitted if the social anxiety disorder is judged to be the predominant disorder,
             in order to increase accrual of a clinically relevant sample.

          -  Patients with significant suicidal ideation (MADRS item 10 score > 3) or who have
             enacted suicidal behaviors within 6 months prior to intake will be excluded from study
             participation and referred for appropriate clinical intervention.