Status:
COMPLETED
Duloxetine Treatment in Elderly With Dysthymia
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Depression
Dysthymic Disorder
Eligibility:
All Genders
60-95 years
Phase:
PHASE4
Brief Summary
Dysthymic disorder (DD) denotes chronic depression with fewer symptoms than major depressive disorder (MDD), and it affects \~ 2-4 % of adults with a similar prevalence in the elderly. In the elderly,...
Detailed Description
HYPOTHESES: 1. Duloxetine will reduce depressive symptomatology over a period of 12 weeks in elderly DD patients. 2. Duloxetine-treated dysthymic patients will have significant improvement in measure...
Eligibility Criteria
Inclusion
- Diagnosis of dysthymic disorder (SCID and DSM-IV)
- Age 60 - 95
- Mini-Mental State Score ≥ 24
- 24-item Hamilton Rating Scale for Depression score 12-25
- Willing and capable of giving informed consent
Exclusion
- Current major depressive episode (SCID and DSM-IV)
- Alcohol or substance dependence during the last year (SCID and DSM-IV)
- Bipolar disorder, schizophrenia and other psychotic disorders(SCID and DSM-IV)
- Clinical stroke, dementia, Huntington's disease, epilepsy or other major neurological disease
- Acute unstable medical conditions
- Active suicidal ideation or plan
- Non-response to duloxetine (minimum 90 mg/day for 6 weeks) during the past year
- A positive urine drug screen for substances of abuse or dependence
- Sensitivity with intolerability to duloxetine
- Use of other medications that may interact with duloxetine, including inhibitors of cytochrome P450 1A2 (CYP1A2) and cytochrome P450 2D6 (CYP2D6), e.g., quinolone antibiotics and type 1-C anti-arrhythmics. Several antidepressant medications, including most SSRIs, are inhibitors of CYP2D6 but these medications are not permitted during this antidepressant treatment trial.
- Patients with hypertension (BP \>140/90 mm Hg on 2 consecutive measurements). For patients with treated hypertension and BP \>140/90, written approval must be obtained from patient's internist allowing them to participate in this study.
- Known liver damage or disease
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01852383
Start Date
January 1 2006
End Date
March 1 2013
Last Update
May 1 2014
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032