Major Depressive Disorder
Conditions
Interventions
Product Name: Duloxetine Hydrochloride
Product Code: LY248686
Pharmaceutical Form: Capsule*
INN or Proposed INN: hidrocloruro de duloxetina
Concentration unit: mg milligram(s)
Concentration type: equa
Sponsors
Lilly S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Male or female patients at least 18 years of age who have previously completed satisfactorily the Lilly sponsored HMDG clinical trial, and who are clinically controlled with Duloxetine, as judge by the investigator. [2] All females must test negative for a urine pregnancy test at Visit 1 Females of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopausal) must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study. Women who are pregnant or breast-feeding may not participate in the study. [3] Must sign the informed consent document (ICD). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: [4] Are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. [5] Are employed by Lilly (that is, employees, temporary contract workers, or designees responsible for conducting the study). Immediate family of Lilly employees may participate in Lilly-sponsored clinical trials, but are not permitted to participate at a Lilly facility. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. [6] Have received treatment within the last 30 days with a drug (not including study drug) that has not received regulatory approval for any indication at the time of study entry. [7] Patients who have entered the optional tapering period of the HMDG study [8] In the opinion of the investigator, patients judged to be at serious suicidal risk. [9] Treatment with a MAOI within 14 days prior to Visit 1 or potential need to use a MAOI during the study or within 5 days of discontinuation of study drug. [10] Frequent and/or severe allergic reactions to multiple medications, or known allergic reactions to duloxetine. [11] Any patient who previously experienced a serious adverse event while taking duloxetine unless approved by the Lilly physician. [12] Any patient who in the last 2 days of study HMDG did not take study medication as prescribed. [13] Moderate or severe hepatic impairment, including but not limited to acute liver injury (such as hepatitis), and severe (Child-Pugh Class C) cirrhosis. [14] End stage renal disease and undergoing dialysis. [15] Unstable narrow angle glaucoma. [16] Known hypersensitivity to duloxetine or any of the inactive ingredients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: N/A;Primary end point(s): No efficacy data will be collected in this study. The primary outcome will be the spontaneously reported adverse events. All patients who have at least one dose of the study drug will be included in the analyses. Frequencies of the adverse events will be used in the analyses.;Main Objective: The primary objective of this study is to provide duloxetine at a flexible dose of 60 mg to 120 mg daily during 6 months for the continuation phase of their treatment for those patients who have previously completed the HMDG clinical trial. The study will assess the safety of duloxetine and will summarize and report spontaneous adverse events. | — |
Countries
Spain
Outcome results
None listed