Wellbutrin XL for Dysthymic Disorder

Condition(s) targeted: Dysthymic Disorder

Intervention: bupropion XL (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: St. Luke's-Roosevelt Hospital Center

Official(s) and/or principal investigator(s):
David J. Hellerstein, MD, Principal Investigator, Affiliation: St. Luke's-Roosevelt Hospital Center, and NY State Psychiatric Institute

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.

Official title: Double-Blind Treatment of Outpatients With Dysthymic Disorder With Wellbutrin XL

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Hamilton Depression Rating Scale, 24 Items (HDRS)

Secondary outcome:

Cornell Dysthymia Rating Scale (CDRS)

Beck Depression Inventory (BDI)

Clinical Global Improvement (CGI)

Global Assessment of Functioning Scale (GAFS)

Detailed description: 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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Mood Disorders Research Program, St. Luke's-Roosevelt Hospital Center, New York, New York 10019, United States

For more information about our program or this study, click here.

Related publications:

Hellerstein DJ, Batchelder S, Kreditor D, Fedak M. Bupropion sustained-release for the treatment of dysthymic disorder: an open-label study. J Clin Psychopharmacol. 2001 Jun;21(3):325-9.

Starting date: November 2004
Last updated: November 19, 2014