Wellbutrin XL for Dysthymic Disorder

Sponsor
St. Luke's-Roosevelt Hospital Center (Other)
Overall Status
Completed
CT.gov ID
NCT00225251
Collaborator
GlaxoSmithKline (Industry)
18
1
2
43
0.4

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
  • 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
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 :
Nov 1, 2004
Actual Primary Completion Date :
May 1, 2008
Actual Study Completion Date :
Jun 1, 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 Names:
  • 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) [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) [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) [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) [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) [10 weeks]

      A clinician rated assessment of patient's overall functioning, ranging from 0 (severely impaired) to 100 (excellent functioning)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Responsible Party:
    St. Luke's-Roosevelt Hospital Center
    ClinicalTrials.gov Identifier:
    NCT00225251
    Other Study ID Numbers:
    • gsk 102149
    First Posted:
    Sep 23, 2005
    Last Update Posted:
    Nov 26, 2015
    Last Verified:
    Oct 1, 2014
    Keywords provided by St. Luke's-Roosevelt Hospital Center
    Additional relevant MeSH terms:

    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

    1. Primary Outcome
    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
    2. Secondary Outcome
    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)
    3. Secondary Outcome
    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)
    4. Secondary Outcome
    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)
    5. Secondary Outcome
    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

    Early termination led to small numbers of subjects analyzed

    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
    Email hellers@nyspi.columbia.edu
    Responsible Party:
    St. Luke's-Roosevelt Hospital Center
    ClinicalTrials.gov Identifier:
    NCT00225251
    Other Study ID Numbers:
    • gsk 102149
    First Posted:
    Sep 23, 2005
    Last Update Posted:
    Nov 26, 2015
    Last Verified:
    Oct 1, 2014