NCT00225251

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2004

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
6.5 years until next milestone

Results Posted

Study results publicly available

November 24, 2014

Completed
Last Updated

November 26, 2015

Status Verified

October 1, 2014

Enrollment Period

3.5 years

First QC Date

September 21, 2005

Results QC Date

May 13, 2014

Last Update Submit

October 29, 2015

Conditions

Dysthymic Disorder

Keywords

Dysthymic DisorderDysthymiaDepressionChronic DepressionWellbutrin XL

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Cornell Dysthymia Rating Scale (CDRS)

    10 weeks

  • Beck Depression Inventory (BDI)

    10 weeks

  • Clinical Global Improvement (CGI)

    10 weeks

  • Global Assessment of Functioning Scale (GAFS)

    10 weeks

Study Arms (2)

bupropion XL

EXPERIMENTAL

Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day

Drug: bupropion XL

Placebo

PLACEBO COMPARATOR

Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day

Other: Placebo

Interventions

bupropion XLDRUG

Antidepressant medication

Also known as: Wellbutrin XL
bupropion XL
PlaceboOTHER

Placebo

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

New York, New York, 10019, United States

Location

Related 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. doi: 10.1097/00004714-200106000-00012.

    PMID: 11386496BACKGROUND

Related Links

MeSH Terms

Conditions

Dysthymic DisorderDepression

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Limitations and Caveats

Early termination led to small numbers of subjects analyzed

Results Point of Contact

Title
David Hellerstein MD
Organization
NY State Psychiatric Institute
hellers@nyspi.columbia.edu
6467748000

Study Officials

  • David J. Hellerstein, MD

    St. Luke's-Roosevelt Hospital Center, and NY State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2005

First Posted

September 23, 2005

Study Start

November 1, 2004

Primary Completion

May 1, 2008

Study Completion

June 1, 2008

Last Updated

November 26, 2015

Results First Posted

November 24, 2014

Record last verified: 2014-10

Locations

US(1)