None listed
Conditions
Interventions
Drug : The TAU will maintain their usual treatment regimen without the addition of any new therapies or medications during the study. ARPA group will be treated with a starting dose of 2 to 5 mg/day o
Sponsors
The Catholic University of Korea, Uijeongbu St. Mary’s Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ?Patients who are 20 or more with a diagnosis of MDD with anxious distress, as defined by DSM-5 specifier ?Subjects who were on same antidepressants and other psychotropic treatment regimen without any changes (= 4 weeks) ?No previous atypical antipsychotic treatment history within 8 weeks ?Depressive and anxiety symptoms at screening/baseline should be - HAMD=18 - HAMA=16 ?Allowed current antidepressants (generic name): Escitalopram, fluoxetine, paroxetine IR/CR, sertraline, bupropion XL(SR), agomelatine, mirtazapine, venlafaxine IR/XR, milnacipran, duloxetine, vortioxetine, tianeptine, desvenlafaxine (doses indicated as label information of manufacturers)
Exclusion criteria
Exclusion criteria: ?Those who are first episode, drug naive MDD subjects ?Those who have a current Axis I diagnosis of delirium, dementia, amnestic or other cognitive disorder, schizophrenia or other psychotic disorder, bipolar I or II disorder, eating disorder, obsessive-compulsive disorder, panic disorder, or posttraumatic stress disorder ?Those who have a clinically significant current Axis II diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder ?Those who experience hallucinations, delusion, or any psychotic symptomatology in the current depressive episode ?Those who have met DSM-5 criteria for any substance use disorder ?Those who have known allergy, hypersensitivity or previous unresponsiveness to aripiprazole or known intolerance to other medications ?Those who have been in significant psychotherapeutic treatments including cognitive-behavioral therapy or other forms of psychotherapy ?Those who are complicated with serious medical problem, such as severe renal, hepatic dysfunction, infectious diseases, or endocrine disorders ?Those who are pregnant or breast-feeding ?Those who have participated in a clinical trial with aripiprazole or any other investigational product within the past month ?Those who had a history of thyroid pathology, neuroleptic malignant syndrome, or serotonin syndrome ?Those who have a significant history of seizure disorders ?Those who have received any new adjunctive antipsychotic and/or mood stabilizers (lithium, lamotrigine, carbamazepine, valproate, etc) on current antidepressant within 4 weeks ?Those who have received any new antianxiety medications on current antidepressant within 4 weeks ?Those who had treatment with any forms of somatic treatments (electroconvulsive therapy, rTMS, etc.) within 2 months ?Those who have current risk of suicide assessed by HAMD (2 or more on #3) ?Those who are likely to require prohibited concomitant therapy during the study ?Those who have received treatment with a monoamine oxidase inhibitor within 2 weeks prior to enrollment ?Those who have been hospitalized within 2 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HAM-A total score;Proportion of subjects with AEs and SAEs, and discontinuations due to AEs and SAEs | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Hamilton depression rating scale (HAMD17) from baseline to Week 8.;Change in Critically useful anxiety outcome scale (CUXOS) from baseline to Week 8.;Change in Clinical Global Impression-Severity of Illness (CGI-S) score from baseline to Week 8.;Change in Sheehan Disability Scale (SDS) total score from baseline to Week 8.;Change in Brief Resilience Scale (BRS) from baseline to Week 8.;Proportion of subjects who achieve a response, defined as = 50% reduction from baseline on the HAMD total score at week 8;Proportion of subjects who achieve a remission, defined as a HAMD total score of = 7 at week 8;Proportion of subjects who achieve a remission, defined as a CGI-I total score of 1 or 2 at week 8 ;Proportion of subjects achieving improvement in clinical benefit at the baseline based on assessment of clinical effectiveness in combination with assessment of tolerability. | — |
Countries
Korea, Republic of
Contacts
Public ContactKyoung-Uk Lee
The Catholic University of Korea, Uijeongbu St. Mary’s Hospital
Outcome results
None listed