Major Depressive Disorder MedDRA version: 9.1 Level: LLT Classification code 10025463 Term: Major depressive disorder, single episode
Conditions
Interventions
Product Name: LuAA21004
Product Code: LuAA21004 10mg
Pharmaceutical Form: Capsule*
Current Sponsor code: LuAA21004
Other descriptive name: 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine
Concent
Sponsors
Takeda Global Research & Development Centre (Europe) Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject eligibility is determined according to the following criteria: 1. The subject has completed the double blind treatment period of either study Lu AA21004_304 or Lu AA21004_305 immediately prior to enrollment in the extension study (ie, the baseline visit is the same visit as the completion visit of the double blind treatment of the preceding protocol). 2. The subject suffers from a MDE as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.xx) at entry into the prior Lu AA21004_304 or Lu AA21004_305 study. 3. The subject is capable of understanding and complying with protocol requirements. 4. Twelve-month continuation treatment with Lu AA21004 is indicated for the treatment of this subject according to the opinion of the investigator. 5. A male subject, or a female subject of childbearing potential, who is sexually active agrees to use adequate contraception from Screening throughout the duration of the study and for 1 month after the last dose of study medication. Women NOT of child bearing potential are defined as those who have been surgically sterilized (documented hysterectomy, bilateral oophorectomy, or tubal ligation) or who are postmenopausal (defined as at least 2 years since last menses). Acceptable methods of contraception are defined in the Contraception and Pregnancy Avoidance Procedure section of the protocol. 6. The subject has signed the Informed Consent Form. No study-related procedures may be performed before the subject has signed the form. 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: In addition to meeting the exclusion criteria for studies Lu AA21004_304 or Lu AA21004_305 at the time of enrollment into those studies respectively, with the exception of the criteria prohibiting previous exposure to Lu AA21004 and investigational drugs, and the criteria prohibiting patients with increased intraocular pressure, or risk of acute narrow-angle glaucoma, the following exclusion criteria apply: 1. The subject with MDD for whom other psychiatric disorders (mania, bipolar disorder, schizophrenia, or any psychotic disorder) have been diagnosed during the prior study. 2. The subject, in the investigator’s opinion, has a significant risk of suicide and/or a score of =5 points on item 10 (suicidal thoughts) of the MADRS. 3. The subject, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason. 4. The patient has a clinically significant moderate or severe ongoing adverse event related to study medication from the prior study. 5. The subject has used/uses disallowed concomitant medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the long-term safety and tolerability of flexible doses of Lu AA21004 (2.5, 5, or 10 mg/day) over a period of 52 weeks in patients with major depressive disorder (MDD) who have completed short-term studies Lu AA21004_304 or Lu AA21004_305.;Secondary Objective: Secondary Objectives: The secondary objectives of this study are: • To evaluate the maintenance of therapeutic effect of flexible doses of Lu AA21004 (2.5, 5, and 10 mg/day) over a period of 52 weeks in patients with MDD. • To evaluate the effect of Lu AA21004 on assessments of depression, anxiety, quality of life, disability, and health care resource utilization. Exploratory Objective: • To assess suicidal ideation and behavior.;Primary end point(s): The safety and tolerability of Lu AA21004 will be evaluated using adverse events, clinical laboratory data (chemistry, hematology, and urinalysis), electrocardiogram (ECG), vital signs, weight and physical examination. Secondary Endpoints Secondary efficacy endpoints for this study are: • Mean change from Baseline in Hamilton Depression Scale – 24 Items (HAM-D24) total score at all visits. • Mean change from Baseline in MADRS total score, HAM-A total score, CGI-S, at Weeks 4, 24, and 52. Patient-Reported Outcome and Pharmacoeconomic Assessments: The following patient-reported outcomes will be evaluated as secondary endpoints: • Medical Outcomes Study (MOS) 36-item Short-Form (SF-36), each of the 8 subscales separately. • Sheehan Disability Scale (SDS). • Health Economic Assessment (HEA) Questionnaire. Exploratory Endpoints • The Columbia-Suicide Severity Rating Scale (C-SSRS) will be utilized as an exploratory assessment. | — |
Countries
France, Germany, Latvia, Lithuania, Netherlands, United Kingdom
Outcome results
None listed