Atypical Depression
Conditions
Keywords
Atypical Depression, Major Depressive Disorder, Dysthymic Disorder, Atypical Features, Duloxetine
Brief summary
This is a Pilot Study to get a first indication whether Duloxetine may be effective for depressed patients with Atypical Features.
Detailed description
This Open Pilot Study will assess whether Duloxetine is effective for patients with Atypical Features. 20 patients having Major Depressive Disorder with Atypical Features or Dysthymic Disorder will receive Duloxetine in open fashion for 8 weeks. Dose will begin with 20 mg/d and increase to PDR maximal dose of 120 mg/d, if tolerated.
Interventions
DRUGDuloxetine
Day 1-7: 20 mg/d; day 8-24: 30 mg/d; day 15-28: 60 mg/d; day 29-56: 120 mg/d. \* dose raises will occur only if pt. is tolerating the previous dose and not remitting.; dose may be lowered or increased in 30 mg increments if pt. has difficulty tolerating.
Sponsors
Eli Lilly and Company
New York State Psychiatric Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* DSM-IV Major Depression or Dysthymia with Atypical Features * Age 18-65 * Physically healthy * HAMD(24) \> 14
Exclusion criteria
* Prior experience with Duloxetine * History of Psychosis or Bipolar Disorder, Borderline Personality Disorder * Unstable medical disorder; any history of Epilepsy * Currently taking medication that can interact with Duloxetine * Current (past six months) Substance Use Disorder (illicit drugs and/or alcohol) * Serious suicidal ideation judged at least somewhat likely to be acted upon or require hospitalization * Current (past two weeks) use of psychoactive medication (four weeks for Fluoxetine) * Pregnancy * Currently breast feeding * Fecund women failing to use acceptable birth control * Refractory Depression (defined as failure to respond to one or more adequate trials of marketed antidepressants \[i.e., \>=2/3 PDR maximum dose for at least 4 weeks\] during current episode) * Serious suicidal ideation, recent (past six months) suicidal activity, any life-time history of serious suicide attempt (e.g., admitted to ICU, any duration of coma) * Currently taking medication deemed effective
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Depression Scale (HAM-D) | 10 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Atypical Depression Diagnostic Scale (ADDS) | 10 weeks |
| Beck Depression Inventory (BDI) | 10 weeks |
| Clinical Global Impression (CGI) | 10 weeks |
| Patient Global Impression (PGI) | 10 weeks |
| Inventory of Depressive Symptoms(IDS) | 10 weeks |
Countries
United States
Outcome results
None listed