Major depressive disorder MedDRA version: 9.1 Level: LLT Classification code 10025453 Term: Major depressive disorder NOS
Conditions
Interventions
Trade Name: CYMBALTA
Pharmaceutical Form: Capsule*
Current Sponsor code: LY248686
Other descriptive name: Duloxetine hydrochloride
Concentration unit: mg/g milligram(s)/gram
Concentration type: range
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible to be included in the study only if they meet all of the following criteria: 1. Outpatient male or female aged 7 to 17 years, inclusive, at the time of signing the informed consent/assent document and diagnosed with MDD as defined by the DSM-IV-TR and supported by the MINIKID. 2. Diagnosis of moderate or greater severity of MDD as determined by CDRS-R with a total score =40 at Visit 1, Visit 2, and Visit 3 and a CGI-Severity rating of =4 at Visit 1, Visit 2, and Visit 3. 3. Female patients must test negative for pregnancy during screening. Furthermore, female patients must agree to abstain from sexual activity or to use a reliable method of birth control as determined by the investigator during the study. Examples of reliable birth control methods include the use of oral contraceptives; a reliable barrier method of birth control (diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices); partner with vasectomy; or abstinence. 4. Patient’s parent/legal representative and patient, if capable, are judged to be reliable by the investigator to keep all appointments for clinical visits, tests, and procedures required by the protocol. 5. Patient’s parent/legal representative and patient, if capable, must have a degree of understanding such that they can communicate intelligently with the investigator and study coordinator. 6. Patients must be capable of swallowing study drug whole (without opening the capsule, crushing, dissolving, dividing, etc.). It is anticipated the patients will need to swallow up to 6 capsules per day. 7. Patients must have venous access sufficient to allow blood sampling and are compliant with blood draws as per the protocol Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria: 8. Are the children of investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. 9. Are the children of Lilly employees or employees of the designated Clinical Research Organisation assisting with the conduct of the study. 10. Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. 11. Have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, or pervasive development disorder, as judged by the investigator. In addition, patients with an Axis II disorder (eg, borderline personality disorder) will be excluded if, in the judgment of the investigator, the Axis II disorder would interfere significantly with protocol compliance. 12. Have a history of DSM-IV-TR-defined substance abuse or dependence within the past year, excluding caffeine and nicotine. 13. Have a current primary DSM-IV-TR Axis I disorder other than MDD or a current secondary DSM-IV-TR Axis I disorder that requires any pharmacologic treatment (other than those disorders listed in Exclusion Criteria 11 and 12). 14. Have 1 or more first-degree relatives (parents or siblings) with diagnosed bipolar I disorder. 15. Have a significant suicide attempt within 1 year of Visit 1 or are currently at risk of suicide in the opinion of the investigator. 16. Have a weight less than 20 kg at any Screening Phase visit. 17. Have a lack of response to 2 or more adequate treatment trials of antidepressants at a clinically appropriate dose for a minimum of 4 weeks for the same MDD episode. In addition, patients who have had a lack of response of their current depressive episode to a clinically appropriate dose of fluoxetine (ie, at least 20 mg/day for 4 weeks) will be excluded. Patients who have had a lack of response of their current depressive episode to duloxetine, as judged by the investigator, will be excluded. 18. Have initiated, stopped, or changed the type or intensity of psychotherapy within 6 weeks prior to Visit 1. Patients who require a change to psychotherapy (start, stop, or change in type, intensity, or frequency) during study Period II will be excluded. 19. Have a history of seizure disorder (other than febrile seizures). 20. Have a history of electroconvulsive therapy (ECT) within 1 year of Visit 1. 21. Have had treatment with a monoamine oxidase inhibitor (MAOI) within 14 days or fluoxetine within 30 days of Visit 3; or the potential need to use an MAOI during the study or within 5 weeks of discontinuation of study drug. 22. Have previously enrolled (ie, received study drug), completed, or withdrawn from this study or any other study investigating duloxetine or fluoxetine. 23. Have a positive urine drug screen for any substances of abuse or excluded medication. Note: If the patient has a positive urine drug screen at Visit 1 for an excluded medication that may not have had an adequate washout period, a re-test may be performed and evaluated prior to Visit 3. 24. Are taking any excluded medications (eg, stimulants or other antidepressants) that cannot be discontinued by Visit 2. 25. Have known hypersensitivity to duloxetine, fluoxetine, or their i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the efficacy of duloxetine compared with placebo in the acute treatment of children (aged 7 through 11 years) and adolescents (aged 12 through 17 years) who meet criteria for MDD without psychotic features, single or recurrent episode, as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR [APA 2000]). The primary objective will be evaluated by assessing the mean change from baseline to endpoint (10 weeks) on the Children’s Depression Rating Scale-Revised (CDRS-R) total score between duloxetine and placebo.;Secondary Objective: EFFICACY • To test assay sensitivity by comparing fluoxetine with placebo • To evaluate the efficacy of treatment with duloxetine compared with placebo • To assess changes in depressive symptoms SAFETY/TOLERABILITY • To evaluate the safety & tolerability of treatment with duloxetine compared with placebo • To assess safety and tolerability of duloxetine PHARMACOKINETICS/PHARMACODYNAMICS • To characterise the pharmacokinetics of duloxetine at steady-state • To compare the steady-state duloxetine pharmacokinetics in the treatment of children & adolescents with MDD with historical adult duloxetine pharmacokinetics. • To investigate the relationship between duloxetine exposure & efficacy endpoints during a 10-week, double-blind, acute treatment phase in children & adolescents with MDD. ;Primary end point(s): The primary objective of this study is to assess the efficacy of duloxetine compared with placebo in the treatment of children and adolescents who meet criteria for MDD without psychotic features, single or recurrent episode, based on the mean change from baseline to endpoint on the CDRS-R total score. The CDRS-R total score will be calculated by summing the 17 individual scores. If three or fewer CDRS-R items are missing, the average of the nonmissing values will be substituted for the missing items. If more th | — |
Countries
Estonia, Finland, France, Germany
Outcome results
None listed