Wellbutrin XL for Dysthymic Disorder
Condition: Dysthymic Disorder
MeSH terms: Dysthymic Disorder
Intervention: bupropion XL; Placebo
Intervention description: Antidepressant medication; Placebo
Intervention MeSH terms: Bupropion
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Dysthymic Disorder; Dysthymia; Depression; Chronic Depression; Wellbutrin XL

Summary:

      This is a ten-week, double-blind study of Wellbutrin XL in outpatients with dysthymic
      disorder, a form of low-grade chronic depression. We hypothesize that patients taking
      Wellbutrin XL will show greater improvement in depression symptoms and psychosocial
      functioning than patients taking placebo.
    

Eligibility criteria:

        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.