Wellbutrin XL for Dysthymic Disorder
Study Details
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 |
---|---|---|
|
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
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 Names:
|
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
- Hamilton Depression Rating Scale, 24 Items (HDRS) [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
- Cornell Dysthymia Rating Scale (CDRS) [10 weeks]
A 24 item scale assessing symptoms of chronic depression. Scores from 0 to 96 with higher score indicating worse depression
- Beck Depression Inventory (BDI) [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.
- Clinical Global Improvement (CGI) [10 weeks]
A global assessment of patient improvement, ranging from 1 (very much improved) to 7 (very much worse)
- Global Assessment of Functioning Scale (GAFS) [10 weeks]
A clinician rated assessment of patient's overall functioning, ranging from 0 (severely impaired) to 100 (excellent functioning)
Eligibility Criteria
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
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | 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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- gsk 102149
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Bupropion XL | Placebo |
---|---|---|
Arm/Group Description | Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day bupropion XL: Antidepressant medication | Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day |
Period Title: Overall Study | ||
STARTED | 11 | 7 |
COMPLETED | 10 | 6 |
NOT COMPLETED | 1 | 1 |
Baseline Characteristics
Arm/Group Title | Bupropion XL | Placebo | Total |
---|---|---|---|
Arm/Group Description | Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day bupropion XL: Antidepressant medication | Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day | Total of all reporting groups |
Overall Participants | 11 | 7 | 18 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
40.6
(11.5)
|
40.0
(10.9)
|
40.3
(11.3)
|
Sex: Female, Male (Count of Participants) | |||
Female |
7
63.6%
|
4
57.1%
|
11
61.1%
|
Male |
4
36.4%
|
3
42.9%
|
7
38.9%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
0
0%
|
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
3
27.3%
|
1
14.3%
|
4
22.2%
|
White |
8
72.7%
|
6
85.7%
|
14
77.8%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Region of Enrollment (participants) [Number] | |||
United States |
11
100%
|
7
100%
|
18
100%
|
Outcome Measures
Title | Hamilton Depression Rating Scale, 24 Items (HDRS) |
---|---|
Description | 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) |
Time Frame | 10 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Bupropion XL | Placebo |
---|---|---|
Arm/Group Description | Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day bupropion XL: Antidepressant medication | Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day |
Measure Participants | 11 | 7 |
Mean (Standard Deviation) [units on a scale] |
14.4
(6.9)
|
13.3
(8.4)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Bupropion XL, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other | |
Comments | ||
Statistical Test of Hypothesis | p-Value | <.05 |
Comments | ||
Method | t-test, 2 sided | |
Comments | ||
Method of Estimation | Estimation Parameter | Mean Difference (Net) |
Estimated Value | 3.0 | |
Confidence Interval |
() % to |
|
Parameter Dispersion |
Type: Value: |
|
Estimation Comments |
Title | Cornell Dysthymia Rating Scale (CDRS) |
---|---|
Description | A 24 item scale assessing symptoms of chronic depression. Scores from 0 to 96 with higher score indicating worse depression |
Time Frame | 10 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Bupropion XL | Placebo |
---|---|---|
Arm/Group Description | Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day bupropion XL: Antidepressant medication | Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day |
Measure Participants | 11 | 7 |
Mean (Standard Deviation) [units on a scale] |
26.4
(10.8)
|
24
(14)
|
Title | Beck Depression Inventory (BDI) |
---|---|
Description | 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. |
Time Frame | 10 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Bupropion XL | Placebo |
---|---|---|
Arm/Group Description | Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day bupropion XL: Antidepressant medication | Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day |
Measure Participants | 11 | 7 |
Mean (Standard Deviation) [units on a scale] |
8
(4.4)
|
12.3
(10.1)
|
Title | Clinical Global Improvement (CGI) |
---|---|
Description | A global assessment of patient improvement, ranging from 1 (very much improved) to 7 (very much worse) |
Time Frame | 10 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Bupropion XL | Placebo |
---|---|---|
Arm/Group Description | Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day bupropion XL: Antidepressant medication | Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day |
Measure Participants | 11 | 7 |
Mean (Standard Deviation) [units on a scale] |
2.8
(1)
|
2.43
(1)
|
Title | Global Assessment of Functioning Scale (GAFS) |
---|---|
Description | A clinician rated assessment of patient's overall functioning, ranging from 0 (severely impaired) to 100 (excellent functioning) |
Time Frame | 10 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Bupropion XL | Placebo |
---|---|---|
Arm/Group Description | Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day bupropion XL: Antidepressant medication | Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day |
Measure Participants | 11 | 7 |
Mean (Standard Deviation) [units on a scale] |
64
(8.6)
|
67
(9.6)
|
Adverse Events
Time Frame | 10 weeks | |||
---|---|---|---|---|
Adverse Event Reporting Description | patients were assessed for side effects over the course of the efficacy study | |||
Arm/Group Title | Bupropion XL | Placebo | ||
Arm/Group Description | Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day bupropion XL: Antidepressant medication | Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day | ||
All Cause Mortality |
||||
Bupropion XL | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Bupropion XL | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/11 (0%) | 0/7 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Bupropion XL | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 6/11 (54.5%) | 3/7 (42.9%) | ||
Gastrointestinal disorders | ||||
dry mouth | 3/11 (27.3%) | 3 | 0/7 (0%) | 0 |
Nervous system disorders | ||||
headache | 4/11 (36.4%) | 4 | 0/7 (0%) | 0 |
dizziness | 2/11 (18.2%) | 2 | 0/7 (0%) | 0 |
insomnia | 1/11 (9.1%) | 1 | 3/7 (42.9%) | 3 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | David Hellerstein MD |
---|---|
Organization | NY State Psychiatric Institute |
Phone | 6467748000 |
hellers@nyspi.columbia.edu |
- gsk 102149