Phase 4
N=65
Duloxetine for Chronic Depression: a Double-blind Study
Dysthymic Disorder · Depressive Disorder NOS
Bottom Line
View on ClinicalTrials.gov: NCT00360724 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcome: Primary: Hamilton Depression Rating Scale (HDRS) - 24 Total Score — 5; 10 Scores on a scale — p=.003
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Duloxetine (Cymbalta) (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hamilton Depression Rating Scale (HDRS) - 24 Total Score |
14.1; 14.9 | — |
| PRIMARY Hamilton Depression Rating Scale (HDRS) - 24 Total Score |
14.1; 14.9 | — |
| SECONDARY Cornell Dysthymia Rating Scale (CDRS) |
36.9; 37.4 | — |
| SECONDARY Global Assessment of Functioning Scale (GAF) |
62.6; 58.3 | — |
| SECONDARY Beck Depression Inventory (BDI) |
12.7; 15.5 | — |
| SECONDARY Clinical Global Impressions Improvement(CGI-I) |
2.4; 3 | — |
| SECONDARY Cornell Dysthymia Rating Scale (CDRS) |
36.9; 37.4 | — |
| SECONDARY Beck Depression Inventory (BDI) |
12.7; 15.5 | — |
| SECONDARY Global Assessment of Functioning Scale (GAF) |
62.6; 58.3 | — |
Summary
The investigators are studying a new antidepressant medicine, duloxetine, for the treatment of people with chronic depression. Duloxetine (trade name Cymbalta) was recently approved by the FDA for the treatment of major depression. The investigators are testing whether this medicine is also effective for adults with chronic depression (dysthymic disorder or dysthymia).
Chronic depression, lasting two or more years, often causes significant suffering and impairment. The investigators study involves a 6 to 10 week double-blind Initial Phase during which half of the participants will take the new medication and half will take a placebo (an inactive look-alike pill). After the Initial Phase, a 12-week Continuation Phase will begin, during which all subjects can be treated with an FDA-approved antidepressant medication.
Eligible subjects may also receive MRI scans, to help the investigators understand how antidepressants work in treating depression.
Eligibility Criteria
Inclusion Criteria
- age 20 to 75 years (ages 20 to 60 for MRI sub-study)
- diagnosis of dysthymic disorder (chronic depression) or depression NOS
- minimum of 2 years duration of current episode of depression
Exclusion Criteria
- current major depression
- diagnoses including delirium, dementia, bipolar disorder, schizophrenia
- substance abuse or dependence in the past 6 months
- pregnant or nursing women
- serious risk of suicide
Data sourced from ClinicalTrials.gov (NCT00360724). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.