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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
This is a Pilot Study to get a first indication whether Duloxetine may be effective for depressed patients with Atypical Features.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Depression Scale (HAM-D) | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Atypical Depression Diagnostic Scale (ADDS) | 10 weeks | |
| Beck Depression Inventory (BDI) | 10 weeks | |
| Clinical Global Impression (CGI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan W. Stewart, M.D. | New York State Psychiatric Institute - Columbia University Department of Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Depression Evaluation Service - New York State Psychiatric Institute | New York | New York | 10032 | United States |
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| Label | URL |
|---|---|
| Depression Evaluation Service - official website | View source |
| New York State Psychiatric Institute - official website | View source |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D019263 | Dysthymic Disorder |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| 10 weeks |
| Patient Global Impression (PGI) | 10 weeks |
| Inventory of Depressive Symptoms(IDS) | 10 weeks |
| D006571 |
| Heterocyclic Compounds |