Wellbutrin XL for Dysthymic Disorder

This is a ten-week, double-blind, placebo-controlled study designed to evaluate the
tolerability, dosing and efficacy of Wellbutrin XL in outpatients who meet Diagnostic and
Statistical Manual-IV criteria for early onset, primary type dysthymic disorder (low-grade
chronic depression). It is hypothesized that patients taking Wellbutrin XL will show greater
improvement in depression symptoms and psychosocial functioning than patients taking
placebo.

Inclusion Criteria:

- Male and female outpatients 18-65 years of age.

- Patients with a Diagnostic and Statistical Manual Fourth Edition (DSM-IV) diagnosis
of dysthymic disorder, early onset.

- Patients will have a total score of 12 or higher on the Hamilton Depression Scale (24
items) at baseline.

Exclusion Criteria:

- Patients with a DSM-IV diagnosis of Delirium, Dementia, and Amnestic, and other
Cognitive Disorders.

- Patients who are pregnant or nursing women.

- Patients with a principal diagnosis meeting DSM-IV criteria for: Major Depressive
disorder, Bipolar Disorder or cyclothymia, Schizophrenia, Delusional (Paranoid)
Disorders and Psychotic Disorders not elsewhere classified, Severe Borderline
Personality Disorder

- Patients who have a current or prior diagnosis of Anorexia Nervosa or Bulimia

- Patients who, within the past 6 months, met DSM-IV criteria for abuse of or
dependence on any drug, including alcohol.

- Patients who would pose a serious risk for suicide during the course of the study, as
evidenced by one of the following:

- Report of having a specific plan for killing themselves,

- A score of 3 or higher on the Hamilton Depression Rating Scale item #3 as rated
by the treating clinician at Week 0, (indicative of active suicidal thoughts or
behaviors), or

- A suicide attempt within the past 12 months requiring emergency room visit,
medical or psychiatric hospitalization, or otherwise deemed to be
life-threatening (e.g. an overdose of > 1 week's dose of medication).

- Patients with a history of recurrent Grand Mal seizures or at risk of Grand Mal
seizures, and those with other medical conditions in which Wellbutrin XL would be
contraindicated, including a history of head trauma.

- Use of any psychotropic medication within 1 week of starting study medication

- Use of a monoamine oxidase inhibitor (a type of antidepressant) (MAOI) within the 14
days prior to the initial dose of study medication.

- Use of fluoxetine within 28 days of the initial dose of study medication.

- Use of Zyban® or other forms of bupropion hydrochloride (i.e. Wellbutrin immediate
release or Wellbutrin Sustained Release (SR)) within 2 weeks of the initial dose of
medication.

- Patients who have failed to respond to adequate trials (minimum of six consecutive
weeks) of two different classes of antidepressant medication (see Table 1 for
definitions of an adequate trial.)

- Patients with unstable medical conditions, such as acute hyperthyroidism, uncorrected
hypothyroidism, undiagnosed fever, uncontrolled angina, or any other serious medical
illness, including any cardiovascular, hepatic, respiratory, hematological,
endocrinologic or neurologic disease, or any clinically significant laboratory
abnormality.

- Patients who have begun a course of psychotherapy within 3 months of starting the
study, or who plan to terminate an ongoing psychotherapy prior to the end of the
study.