Wellbutrin XL for Dysthymic Disorder
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Dysthymic Disorder |
Drug: bupropion XL |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Double-Blind Treatment of Outpatients With Dysthymic Disorder With Wellbutrin XL |
- Hamilton Depression Rating Scale, 24 items (HDRS) [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]Widely used depression rating scale, with range of scores from 0 to 90, with higher scores reflecting greater level of depression. Assesses suicidality which is a safety issue.
- Cornell Dysthymia Rating Scale (CDRS) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]A 24 item scale assessing symptoms of chronic depression. Scores from 0 to 96 with higher score indicating worse depression
- Beck Depression Inventory (BDI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]Self rated scale rated by patients for depression symptoms
- Clinical Global Improvement (CGI) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]A global assessment of patient improvement, ranging from 1 (very much improved) to 7 (very much worse)
- Global Assessment of Functioning Scale (GAFS) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]A clinician rated assessment of patient's overall functioning, ranging from 0 (severely impaired) to 100 (excellent functioning)
| Enrollment: | 18 |
| Study Start Date: | November 2004 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male and female outpatients 18-65 years of age.
- Patients with a 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| United States, New York | |
| Mood Disorders Research Program, St. Luke's-Roosevelt Hospital Center | |
| New York, New York, United States, 10019 | |
| Principal Investigator: | David J. Hellerstein, MD | St. Luke's-Roosevelt Hospital Center, and NY State Psychiatric Institute |
More Information
Additional Information:
Publications:
| Responsible Party: | St. Luke's-Roosevelt Hospital Center |
| ClinicalTrials.gov Identifier: | NCT00225251 History of Changes |
| Other Study ID Numbers: | gsk 102149 |
| Study First Received: | September 21, 2005 |
| Last Updated: | February 26, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by St. Luke's-Roosevelt Hospital Center:
|
Dysthymic Disorder Dysthymia Depression Chronic Depression Wellbutrin XL |
Additional relevant MeSH terms:
|
Dysthymic Disorder Depressive Disorder Mood Disorders Mental Disorders Bupropion Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents |
Therapeutic Uses Pharmacologic Actions Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013