Duloxetine Treatment in Elderly With Dysthymia
Depression, Dysthymic Disorder
About this trial
This is an interventional treatment trial for Depression focused on measuring Duloxetine, Antidepressant, Depression, Dysthymic Disorder, Side Effects, Elderly
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- New York State Psychiatric Institute
Arms of the Study
Arm 1
Experimental
Duloxetine
A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily. At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Administration was as a single a.m. dose.