Major Depressive Disorder (MDD) MedDRA version: 14.0 Level: LLT Classification code 10025454 Term: Major depressive disorder, recurrent episode System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: Aripiprazole/Escitalopram 3-10 mg Combination Capsule
Product Code: OPC-14597
Pharmaceutical Form: Capsule
INN or Proposed INN: ARIPIPRAZOLE
CAS Number: 129722-12-9
Concentration unit: m
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who are able to provide written informed consent and/or consent obtained from a legally acceptable representative (as required by IRB/IEC), prior to the initiation of any protocol-required procedures. 2. Ability, in the opinion of the principal investigator, to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet/capsule ingestion, and discontinuation of prohibited concomitant medication; to read and understand the written word in order to complete subject-reported outcomes measures; and to be reliably rated on assessment scales. 3. Male or female outpatients 18 to 66 years of age, inclusive, at the time of informed consent. 4. Subjects who have participated in Protocol 31-08-255, 31-08-256 or 31-08-263 and who, in the opinion of the investigator, could potentially benefit form the administration of oral aripiprazole/escitalopram combination therapy. Eligible subjects include those who: a) completed participation in the Randomization Phase (Phase C, Week 14 Visit) or b) met criteria for a response at the end of the Prospective treatment Phase (Phase B, Week 8 Visit) and at the end of Phase B+ (Week 14 Visit) did not meet criteria for remission (defined as a MADRS Total Score ==65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Sex and Reproductive Status 1. Sexually active males or females of childbearing potential who are not practicing two different methods of birth control during the study and for 90 or 30 days respectively after the last dose of study medication or who will not remain abstinent during the study and for 90 or 30 days respectively after the last dose. (*) 2. Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug. Target Disease 3. Subjects with a current need for involuntary commitment or who have been hospitalized 3x upper limit of normal as defined by the central laboratory; ALT > 3x upper limit of normal as defined by the central laboratory; Creatinine >= 2 mg/dL; (*) Prohibited Therapies or Medications 15. Subjects who would be likely to require prohibited prior or concomitant therapy during the trial (*) 16. Anticipated need for diphenylhydramine or hydroxyzine during the study and other antihistamines for the treatment of agitation, anxiety or insomnia. Allergies and Adverse Drug Reactions 17. History of allergy or hypersensitivity to aripiprazole or escitalopram. 18. Subjects with a history of neuroleptic malignant syndrome or serotonin syndrome. Other 19. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg. infectious disease) illness must not b
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the 52-week safety and tolerability of an oral aripiprazole/escitalopram combination therapy in the treatment of patients with MDD.;Secondary Objective: N/A;Primary end point(s): The primary outcome variable of safety will be the frequency and severity of AEs, including serious AEs (SAEs) and discontinuations from the study due to AEs.;Timepoint(s) of evaluation of this end point: Refer to E.5.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary efficacy variables will include the mean Clinical Global Impression - Severity of Illness Scale (CGI-S) score, and the mean Patient Global Impression of Severity (PGI-S) score at baseline and at each time point. In addition to AEs, safety variables examined in this study will include physical examinations, vital signs, body weight, body mass index (BMI), clinical laboratory tests (including, but not limited to, prolactin and hemoglobin A1c), electrocardiograms (ECGs), the Abnormal Involuntary Movement Scale (AIMS), the Simpson Angus Scale (SAS), the Barnes Akathisia Rating Scale (BARS), the Columbia-Suicide Severity Rating Scale (C-SSRS), and the Massachusetts General Hospital Sexual Functioning Inventory (MGH SFI). Outcome variables will be evaluated for the mean Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) scores, the mean Sheehan Disability Scale (SDS) score, and the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) score. Responses to the Resource Utilization Form will be summarized appropriately to explore the impact of treatment on health care resources.;Timepoint(s) of evaluation of this end point: Multiple timepoints (refer to Table 3.6.1 in the protocol for details) | — |
Countries
Australia, Bulgaria, Canada, Croatia, Estonia, Finland, France, Germany, Hungary, India, Italy, Korea, Republic of, Malaysia, Mexico, Philippines, Poland, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sweden, Taiwan, Ukraine, United States
Contacts
Public ContactDorota Plewicka, MD
Covance
Outcome results
None listed