Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| F1J-MC-HMBU |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
How duloxetine compares to a medication currently available for the treatment of patients diagnosed with depression
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine Hydrochloride | Drug | |||
| Venlafaxine Extended Release | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The linear measure of global benefit-risk assessment. Benefit defined as remission at endpoint (HAMD 17 total score less than or equal to 7), a virtually symptom-free state. |
| Measure | Description | Time Frame |
|---|---|---|
| HAMD17 Response Rates defined as greater than or equal to 50% reduction in HAMD17 total score from baseline to endpoint. | ||
| HAMD17 Time-to-First Response defined as the visit where a sustained greater than or equal to 30% reduction in the Maier subscale of the HAMD17. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM - 5 PM Easter Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | La Rochelle |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25080392 | Derived | Dodd S, Berk M, Kelin K, Zhang Q, Eriksson E, Deberdt W, Craig Nelson J. Application of the Gradient Boosted method in randomised clinical trials: Participant variables that contribute to depression treatment efficacy of duloxetine, SSRIs or placebo. J Affect Disord. 2014 Oct;168:284-93. doi: 10.1016/j.jad.2014.05.014. Epub 2014 Jun 4. |
Not provided
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| HAMD17 Remission Rates defined as HAMD17 total score of less than or equal to 7 at endpoint. |
| Hamilton Anxiety Rating Scale measures the presence and severity of anxiety. |
| Clinical Global Impressions of Severity scale to record severity of illness at the time of assessment. |
| Patient's Global Impressions of Improvement scale measures improvement of the patient's symptoms. |
| HAMD17 Subscales evaluate severity of psychic and somatic manifestations of anxiety as well as agitation and evaluate dysfunction in mood, work, and sexual activity, as well as overall motor retardation and evaluate initial, middle, and late insomnia. |
| France |
| D006571 |
| Heterocyclic Compounds |