Duloxetine for Social Anxiety Disorder: Prediction of Long Term Outcome

Inclusion Criteria:

• Male or female outpatients > 18 years of age with a primary psychiatric diagnosis ofgeneralized social anxiety disorder as defined by DSM-IV criteria and an LSAS score >

• Physical examination, electrocardiogram, and laboratory findings without clinicallysignificant 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 ofduloxetine at highest tolerated dose (<120mg/day).

• Patients with acute narrow angle glaucoma.

• Pregnant women, lactating women, and women of childbearing potential who are not usingmedically accepted forms of contraception (e.g., IUD, oral contraceptives, barrierdevices, condoms and foam, or implanted progesterone rods stabilized for at least 3months).

• Concurrent use of other psychotropic medications. Patients must discontinue regularbenzodiazepine or antidepressant therapy at least one week (5 weeks for fluoxetine)prior to baseline. Concomitant beta-blockers are proscribed unless prescribed for amedical indication (e.g., hypertension, at a stable daily dose for > 1 month).

• Patients with a history of failure to satisfactorily respond to >2 prior adequatetreatment trials.

• Significant personality dysfunction likely to interfere with study participation.

• Serious medical illness or instability for which hospitalization may be likely withinthe next year.

• Seizure disorders with the exception of a history of febrile seizures if they occurredduring childhood, were isolated, and did not recur in adulthood.

• Concurrent psychotherapy initiated within 2 months of baseline is prohibited. Ongoingpsychotherapy of any duration directed specifically toward treatment of the socialanxiety disorder is excluded. Prohibited psychotherapy includes cognitive behavioraltherapy or psychodynamic therapy that focuses on exploring specific, dynamic causes ofthe phobic symptomatology and provides skills for their management. General supportiveindividual, 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: alifetime history of schizophrenia or any other psychosis, mental retardation, organicmedical disorders or bipolar disorder; eating disorders in the past 6 months; alcoholor substance abuse in the past 3 months or dependence within the past 6 months.

• Entry of patients with major depression, dysthymia, panic disorder, generalizedanxiety disorder, post-traumatic stress disorder or obsessive-compulsive disorder willbe 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 haveenacted suicidal behaviors within 6 months prior to intake will be excluded from studyparticipation and referred for appropriate clinical intervention.