Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00185575
Status:
COMPLETED
Last Update Posted:
2009-04-09
First Post:
2005-09-09
Brief Title:
Duloxetine for the Treatment of Dysthymia
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
Duloxetine for the Treatment of Dysthymia
Status:
COMPLETED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test the hypothesis that duloxetine Cymbalta in doses of 60 or 120 mgday 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 60mgday 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 mgday If they experience side effects the dose can be decreased to 30 mgday for several days but will be increased back to 60 mgday by the end of the first week If subjects are unable to tolerate a dose of 60 mgday 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 mgday 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
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 60mgday 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 mgday If they experience side effects the dose can be decreased to 30 mgday for several days but will be increased back to 60 mgday by the end of the first week If subjects are unable to tolerate a dose of 60 mgday 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 mgday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None