Wellbutrin XL for Dysthymic Disorder

• ClinicalTrials.gov Identifier: NCT00225251
• Recruitment Status: Completed
• First Posted: September 23, 2005
• Results First Posted: November 24, 2014
• Last Update Posted: November 26, 2015
• Sponsor: St. Luke's-Roosevelt Hospital Center
• Collaborator: GlaxoSmithKline
• Information provided by (Responsible Party): St. Luke's-Roosevelt Hospital Center

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Dysthymic Disorder	Drug: bupropion XL; Other: Placebo	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Double-Blind Treatment of Outpatients With Dysthymic Disorder With Wellbutrin XL
• Study Start Date: November 2004
• Actual Primary Completion Date: May 2008
• Actual Study Completion Date: June 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: bupropion XL; Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day	Drug: bupropion XL; Antidepressant medication; Other Name: Wellbutrin XL
Placebo Comparator: Placebo; Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day	Other: Placebo; Placebo

Outcome Measures

Primary Outcome Measures :

1. Hamilton Depression Rating Scale, 24 Items (HDRS) [ Time Frame: 10 weeks ]

   Widely used depression rating scale, with higher scores reflecting greater level of depression. Assesses suicidality which is a safety issue.

   This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7)

Secondary Outcome Measures :

1. Cornell Dysthymia Rating Scale (CDRS) [ Time Frame: 10 weeks ]
   A 24 item scale assessing symptoms of chronic depression. Scores from 0 to 96 with higher score indicating worse depression
2. Beck Depression Inventory (BDI) [ Time Frame: 10 weeks ]
   21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.
3. Clinical Global Improvement (CGI) [ Time Frame: 10 weeks ]
   A global assessment of patient improvement, ranging from 1 (very much improved) to 7 (very much worse)
4. Global Assessment of Functioning Scale (GAFS) [ Time Frame: 10 weeks ]
   A clinician rated assessment of patient's overall functioning, ranging from 0 (severely impaired) to 100 (excellent functioning)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, New York

Mood Disorders Research Program, St. Luke's-Roosevelt Hospital Center

New York, New York, United States, 10019

Sponsors and Collaborators

St. Luke's-Roosevelt Hospital Center

GlaxoSmithKline

Investigators

• Principal Investigator: David J. Hellerstein, MD; St. Luke's-Roosevelt Hospital Center, and NY State Psychiatric Institute

More Information

Additional Information:

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

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.

• Responsible Party: St. Luke's-Roosevelt Hospital Center
• ClinicalTrials.gov Identifier: NCT00225251
• Other Study ID Numbers: gsk 102149
• First Posted: September 23, 2005
• Results First Posted: November 24, 2014
• Last Update Posted: November 26, 2015
• Last Verified: October 2014

Keywords provided by St. Luke's-Roosevelt Hospital Center:

Dysthymic Disorder; Dysthymia; Depression; Chronic Depression; Wellbutrin XL

Additional relevant MeSH terms:

Disease; Dysthymic Disorder; Pathologic Processes; Depressive Disorder; Mood Disorders; Mental Disorders; Bupropion; Antidepressive Agents, Second-Generation; Antidepressive Agents; Psychotropic Drugs; Dopamine Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Dopamine Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Enzyme Inhibitors