Wellbutrin XL for Dysthymic Disorder

Dysthymic Disorder Clinical Trial

Official title:

Double-Blind Treatment of Outpatients With Dysthymic Disorder With Wellbutrin XL

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00225251
• Other study ID #: gsk 102149
• Status: Completed
• Phase: Phase 4
• First received: September 21, 2005
• Last updated: October 29, 2015
• Start date: November 2004
• Est. completion date: June 2008

Study information

• Verified date: October 2014
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Dysthymic Disorder

Intervention

Drug:
• bupropion XL
Antidepressant medication

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Mood Disorders Research Program, St. Luke's-Roosevelt Hospital Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
St. Luke's-Roosevelt Hospital Center	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale, 24 Items (HDRS)	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)	10 weeks	Yes
Secondary	Cornell Dysthymia Rating Scale (CDRS)	A 24 item scale assessing symptoms of chronic depression. Scores from 0 to 96 with higher score indicating worse depression	10 weeks	No
Secondary	Beck Depression Inventory (BDI)	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.	10 weeks	No
Secondary	Clinical Global Improvement (CGI)	A global assessment of patient improvement, ranging from 1 (very much improved) to 7 (very much worse)	10 weeks	No
Secondary	Global Assessment of Functioning Scale (GAFS)	A clinician rated assessment of patient's overall functioning, ranging from 0 (severely impaired) to 100 (excellent functioning)	10 weeks	No

External Links

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