Depressive DisorderNCT00185575
Duloxetine for the Treatment of Dysthymia
A study testing duloxetine in people with Depressive Disorder, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to test the hypothesis that duloxetine (Cymbalta), in doses of 60 or 120 mg/day, is an effective and tolerable treatment for adult outpatients suffering from dysthymia. Dysthymia is chronic, mild depression characterized by feeling sad or low more days than not for more than 2 years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- duloxetine
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Apr 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign an informed consent form
- 18 years of age or older
- Females not pregnant or breastfeeding or planning pregnancy and using an acceptable form of contraception
- Meet DSM-IV criteria for dysthymia
- A screening IDS-C score of 17 or greater
- No history of serious or unstable medical disorder
Show all 20Show fewer
- Not taking any significant concurrent medications
- Not currently receiving psychotherapy Exclusion Criteria:- Suffering from DSM-IV defined
- delirium, dementia, amnestic, or other cognitive disorders
- mental disorders due to a general medical condition
- factitious or somatoform disorders
- mental retardation or developmental disabilities
- substance or alcohol abuse within the last 3 months
- depressive disorders with current suicidal risk
- psychotic disorders including delusional disorder, somatic type
- dissociative disorder
- personality disorders sufficiently severe to interfere with study participation
- History of DSM-IV defined bipolar I or II disorder
- History of non-response of dysthymia to adequate antidepressant medication
- History of major depression refractory to two adequate trials of antidepressants
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
The purpose of this study is to test the hypothesis that duloxetine (Cymbalta), in doses of 60 or 120 mg/day, is an effective and tolerable treatment for adult outpatients suffering from dysthymia. Dysthymia is chronic, mild depression characterized by feeling sad or low more days than not for more than 2 years.
Read the detailed description
The purpose of this research is to obtain information on the safety and effectiveness of duloxetine (Cymbalta) in the treatment of dysthymia. Duloxetine has been approved by the federal Food and Drug Administration for the treatment of depression. The use of duloxetine for treatment of dysthymia is considered experimental.
Dysthymia is defined as chronic, low-grade depression, characterized by feeling low or depressed, that lasts for two or more years. Additional symptoms may include: poor appetite or overeating; insomnia or sleeping too much; low energy or fatigue; low self-esteem; poor concentration or difficulty making decisions; and feelings of hopelessness.
Dysthymia affects 3-6% of the general population, but is an underdiagnosed and undertreated disorder. In double-blind, placebo-controlled clinical trials of antidepressant medications, dysthymia response rates are around 60%, compared to an average placebo response rate of about 30%. Duloxetine has not been studied in the treatment of dysthymia, but has shown results in the treatment of major depression. In a 9-week, double-blind, placebo-controlled study of 257 patients with major depression, 65% responded to duloxetine 60mg/day, compared to 43% to placebo. Based on these results, it is highly likely that duloxetine will be an effective treatment for dysthymia.
This research study is being conducted at Stanford University Medical Center with a total of 24 patients, age 18 and above, with dysthymia.
In the study, subjects will receive duloxetine for 12 weeks. This is an open-label study, which means that every subject receives the study medication.
In total, subjects are seen for 10 visits across 13 weeks. At each visit subjects' heart rate, blood pressure and weight measurements will be obtained. At each visit study personnel will interview subjects about their symptoms, monitor side effects and ask them to complete study questionnaires.
Beginning at the second visit, subjects receive duloxetine 60 mg/day. If they experience side effects, the dose can be decreased to 30 mg/day for several days, but will be increased back to 60 mg/day by the end of the first week. If subjects are unable to tolerate a dose of 60 mg/day due to side effects, they will be withdrawn from the study. At the end of 6 weeks, if they have not responded to the study medication (as determined by doctor ratings based on subjects' reports), the dose of duloxetine will be increased to 120 mg/day, unless subjects are experiencing troubling side effects. Subjects continue on the minimum dose that brings about remission or the maximum tolerated dose for the remaining 6 weeks. Medication dosing will be flexible and determined by tolerance (side effects) and therapeutic effect.
- Conditions
- Depressive Disorder
- Being tested
- duloxetine
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
duloxetineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Inventory of Depressive Symptomatology (Clinician-Rated)
Secondary outcomes (5)
Clinical Global Impressions - Improvement
Zung Self-Rating Depression Scale
Patient Global Improvement
Brief Pain Inventory
WHO-QOL 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Investigators
- Lorrin M Koran, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00185575
- Sponsor's protocol ID
- SUSPO30478
- Status last verified
- Apr 2009
- First submitted
- 9 Sep 2005
- Last updated
- 9 Apr 2009
- Results posted
- No
Publications
Koran LM, Aboujaoude EN, Gamel NN. Duloxetine treatment of dysthymia and double depression: an open-label trial. J Clin Psychiatry. 2007 May;68(5):761-5. doi: 10.4088/jcp.v68n0514.
PubMed 17503986
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duloxetine for the Treatment of Dysthymia
- ClinicalTrials.gov ID
- NCT00185575
- Acronym / sponsor ID
- SUSPO30478
- Conditions
- Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Sep 2004
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the hypothesis that duloxetine (Cymbalta), in doses of 60 or 120 mg/day, is an effective and tolerable treatment for adult outpatients suffering from dysthymia. Dysthymia is chronic, mild depression characterized by feeling sad or low more days than not for more than 2 years.
Detailed description
The purpose of this research is to obtain information on the safety and effectiveness of duloxetine (Cymbalta) in the treatment of dysthymia. Duloxetine has been approved by the federal Food and Drug Administration for the treatment of depression. The use of duloxetine for treatment of dysthymia is considered experimental.
Dysthymia is defined as chronic, low-grade depression, characterized by feeling low or depressed, that lasts for two or more years. Additional symptoms may include: poor appetite or overeating; insomnia or sleeping too much; low energy or fatigue; low self-esteem; poor concentration or difficulty making decisions; and feelings of hopelessness.
Dysthymia affects 3-6% of the general population, but is an underdiagnosed and undertreated disorder. In double-blind, placebo-controlled clinical trials of antidepressant medications, dysthymia response rates are around 60%, compared to an average placebo response rate of about 30%. Duloxetine has not been studied in the treatment of dysthymia, but has shown results in the treatment of major depression. In a 9-week, double-blind, placebo-controlled study of 257 patients with major depression, 65% responded to duloxetine 60mg/day, compared to 43% to placebo. Based on these results, it is highly likely that duloxetine will be an effective treatment for dysthymia.
This research study is being conducted at Stanford University Medical Center with a total of 24 patients, age 18 and above, with dysthymia.
In the study, subjects will receive duloxetine for 12 weeks. This is an open-label study, which means that every subject receives the study medication.
In total, subjects are seen for 10 visits across 13 weeks. At each visit subjects' heart rate, blood pressure and weight measurements will be obtained. At each visit study personnel will interview subjects about their symptoms, monitor side effects and ask them to complete study questionnaires.
Beginning at the second visit, subjects receive duloxetine 60 mg/day. If they experience side effects, the dose can be decreased to 30 mg/day for several days, but will be increased back to 60 mg/day by the end of the first week. If subjects are unable to tolerate a dose of 60 mg/day due to side effects, they will be withdrawn from the study. At the end of 6 weeks, if they have not responded to the study medication (as determined by doctor ratings based on subjects' reports), the dose of duloxetine will be increased to 120 mg/day, unless subjects are experiencing troubling side effects. Subjects continue on the minimum dose that brings about remission or the maximum tolerated dose for the remaining 6 weeks. Medication dosing will be flexible and determined by tolerance (side effects) and therapeutic effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Sign an informed consent form
- 18 years of age or older
- Females not pregnant or breastfeeding or planning pregnancy and using an acceptable form of contraception
- Meet DSM-IV criteria for dysthymia
- A screening IDS-C score of 17 or greater
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| duloxetine | Drug | – |
Primary outcome
Inventory of Depressive Symptomatology (Clinician-Rated)
5 secondary outcomes
Clinical Global Impressions - Improvement
Zung Self-Rating Depression Scale
Patient Global Improvement
Brief Pain Inventory
WHO-QOL 100
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2009.
- Results publication: PubMed 17503986Koran LM, Aboujaoude EN, Gamel NN. Duloxetine treatment of dysthymia and double depression: an open-label trial. J Clin Psychiatry. 2007 May;68(5):761-5. doi: 10.4088/jcp.v68n0514.
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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.
Lorrin M Koran principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing duloxetine in people with Depressive Disorder, run by Stanford University 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 20 inclusion and 0 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 9 Apr 2009. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Inventory of Depressive Symptomatology (Clinician-Rated). 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 NCT00185575, 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 9 Apr 2009.