Major Depressive Disorder (MDD) MedDRA version: 12.1 Level: LLT Classification code 10025454 Term: Major depressive disorder, recurrent episode
Conditions
Interventions
Trade Name: ABILIFY 3 mg Tablet
Pharmaceutical Form: Over encapsulated tablet
INN or Proposed INN: ARIPIPRAZOLE
CAS Number: 129722-12-9
Concentration unit: mg milligram(s)
Concentration type: equal
Co
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 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 and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent. 4. Subjects with current diagnosis of a major depressive episode, as defined by DSM-IV-TR criteria and confirmed by M.I.N.I. The current depressive episode must be >= 8 weeks in duration and fulfil the following criteria: Subjects who have a history for the current depressive episode of an inadequate response to at least one and no more than three adequate trials of an approved antidepressant treatment other than escitalopram. An inadequate response is defined as = 50% improvement on any antidepressant trial in the current episode, then the subject must have had an inadequate response to a subsequent adequate antidepressant trial (as defined above by the ATRQ) of another antidepressant treatment prior to the Screen Visit. For the most recent antidepressant trial, the subject must not report >= 50% improvement (as defined above by the ATRQ). 5. Subjects with a HAM-D17 Total Score >= 18 at the Baseline Visit for the Prospective Treatment Phase. 6. Subjects willing to discontinue all prohibited psychotropic medication starting from the time of signing the informed consent and during the study period (*). Inclusion Criteria Required for Entry into Phase C (Double-blind Randomization Phase) 7. HAM-D17 Total Score >= 14 at the Week 8 visit 8. HAM-D17 Total Score at the Week 8 Visit is less that a 50% reduction from the Baseline Visit 9. CGI-I score >= 3 at the Week 6 and Week 8 visits. * please see protocol for further information 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) 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. Lack of prior treatment with an antidepressant during the current depressive episode. 4. Subjects who report treatment with adjunctive monotherapy antipsychotic treatment during the current depressive episode. 5. Subjects who have received ECT in the last 10 years. 6. Subjects who have had a vagus nerve stimulation device implanted for management of treatment-resistant depression, or have received any of the additional somatic treatments listed in protocol* up to and including the past 10 years and/or for the current depressive episode 7. 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 a
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of an oral aripiprazole/escitalopram in combination therapy (3 mg/10 mg, 3 mg/20 mg, 6 mg/10 mg, 6 mg/20 mg, 12 mg/10 mg, 12 mg/20 mg) with aripiprazole monotherapy (3 mg, 6 mg, 12 mg) and escitalopram monotherapy (10 mg, 20 mg) in patients with MDD who demonstrate an incomplete response to a prospective 8-week trial of escitalopram monotherapy.;Secondary Objective: To evaluate the safety and tolerability of an oral aripiprazole/escitalopram combination therapy in patients with MDD who demonstrate an incomplete response to a prospective 8-week trial in escitalopram monotherapy.;Primary end point(s): The primary outcome variable for determination of efficacy is the mean change from end of Phase B (Week 8 Visit) to end of Phase C (Week 14 Visit) in the MADRS Total Score using the last-observation-carried-forward (LOCF) data set. Additionally, a mixed-effect repeated measures (MMRM) model will be used as a sensitivity analysis for the change from the end of Phase B (Week 8 Visit) to the end of Phase C (Week 14 Visit) on the MADRS Total Score. The statistical analysis will be performed by two-sample t-test within an analysis of covariance (ANCOVA) model. The model will include baseline (Week 8 Visit) MADRS Total Score as a covariate and treatment as the main effect. | — |
Countries
France, Hungary, Spain, Sweden
Outcome results
None listed