Dysthymic DisorderPhase 4NCT00225251
Wellbutrin XL for Dysthymic Disorder
A Phase 4 study testing bupropion XL in people with Dysthymic Disorder, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dysthymic Disorder
- What is being tested?
- bupropion XL
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Jun 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mood Disorders Research Program, St. Luke's-Roosevelt Hospital Center
New York, New York, 10019
About this study
Official title: Double-Blind Treatment of Outpatients With Dysthymic Disorder With Wellbutrin XL
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.
Read the 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.
- Conditions
- Dysthymic Disorder
- Being tested
- bupropion XL, Placebo
- Keywords
- Dysthymic Disorder, Dysthymia, Depression, Chronic Depression, Wellbutrin XL
- Medical subject headings
- Dysthymic Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupropion XLDrug
Also called Wellbutrin XL
Antidepressant medication
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| bupropion XL | Experimental | Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day Receives: Drug: bupropion XL |
| Placebo | Placebo comparator | Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 10 weeks
Secondary outcomes (4)
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
Measured: 10 weeks
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.
Measured: 10 weeks
Clinical Global Improvement (CGI)
A global assessment of patient improvement, ranging from 1 (very much improved) to 7 (very much worse)
Measured: 10 weeks
Global Assessment of Functioning Scale (GAFS)
A clinician rated assessment of patient's overall functioning, ranging from 0 (severely impaired) to 100 (excellent functioning)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionMay 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dysthymic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- David J. Hellerstein, MD, Principal investigator, St. Luke's-Roosevelt Hospital Center, and NY State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225251
- Sponsor's protocol ID
- gsk 102149
- Status last verified
- Oct 2014
- First submitted
- 21 Sep 2005
- Last updated
- 26 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 11386496
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind Treatment of Outpatients With Dysthymic Disorder With Wellbutrin XL
- ClinicalTrials.gov ID
- NCT00225251
- Acronym / sponsor ID
- gsk 102149
- Conditions
- Dysthymic Disorder
- Keywords
- Dysthymic Disorder, Dysthymia, Depression, Chronic Depression, Wellbutrin XL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Nov 2004
- Primary completion
- May 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 23 Sep 2005 (estimated)
- Results
- Posted 24 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bupropion XL | Experimental | Drug: bupropion XLTreatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day |
| Placebo | Placebo comparator | Other: PlaceboPlacebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bupropion XLAlso: Wellbutrin XLAntidepressant medication | Drug | bupropion XL |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Hamilton Depression Rating Scale, 24 Items (HDRS)
Time frame: 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)
4 secondary outcomes
Cornell Dysthymia Rating Scale (CDRS)
Time frame: 10 weeks
Beck Depression Inventory (BDI)
Time frame: 10 weeks
Clinical Global Improvement (CGI)
Time frame: 10 weeks
Global Assessment of Functioning Scale (GAFS)
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11386496Hellerstein 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.
- For more information about our program or this study, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David J. Hellerstein, MD principal investigator
St. Luke's-Roosevelt Hospital Center, and NY State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bupropion XL in people with Dysthymic Disorder, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale, 24 Items (HDRS) (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00225251, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2015.