The objective of this study is to compare the efficacy and safety of aripiprazole as adjunctive therapy versus switching to different class of antidepressants for treating major depressive disorder partially or minimally responsive to ongoing antidepressant treatment.
Most guidelines have suggested that those nonresponders or partial responders should be considered for a switch, combination or augmentation of treatment. Traditional augmentation agents, lithium, triiodothyronine (T3), buspirone, dopamine agonists, and stimulants have been commonly used for this patient population with limited supporting data. Recently, augmentation of atypical antipsychotics with antidepressant therapy has become a more commonly accepted treatment practice. This strategy has proven to be useful for enhancement of antidepressant effect, showing increased remission rates and early treatment effects on core depressive symptoms, and comorbid symptoms as well as antidepressant- mediated side effects (e.g., sexual dysfunction). Although, we have some limited treatment options to treat such patients as described above, it is not clear which treatment option would be best or acceptable for those patients in clinical practice yet. Among above augmentation agents, aripiprazole is the first drug approved by U.S. FDA. as an augmentation therapy to antidepressants in the treatment of patients with MDD showing imminent efficacy and reliable safety profile through adequately-powered well-designed controlled clinical trials.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
90
patients who are randomly assigned to adjunctive aripiprazole are treated with a starting dose of 2.5 (or 5) mg/day of aripiprazole, which can be increased weekly in 2.5\~5mg/day increments to a maximum dose of 15 mg/day based on assessment of tolerability and clinical response. Doses can be decreased at any visit, based on tolerability; They continue to receive the same fixed-dose of the previously used antidepressant throughout the study period when patient is assigned to aripiprazole augmentation group.
Patients randomly assigned to switching to different antidepressant have to discontinue the previously used antidepressant and receive different antidepressant within flexible therapeutic doses as indication label information (as based on clinicians' preference and experience). Dose increase is permitted until the first 2 weeks of the study.
Korean Univ Ansan Hospital; Bucheon St.Mary Hospital; DonggukUniv Gyeongju Hospital; Catholic University of Korea St. Paul's Hospital
Seoul, South Korea
Chang Gung Memorial Hospital; Kaohsiung Medical University Chung-ho Memorial Hospital
Taipei, Taiwan
Change of total score of MADRS
MADRS: montgomery Asberg Depression Rating Scale
Time frame: From baseline to end of treatment
Response rate
response rate is defined as a reduction in MADRS total score of at least 50% relative to the beginning of the randomized phase (baseline)
Time frame: at 2 weeks
Response rate
Time frame: at week 2,4 and 6
Remission rate
remission rate is defined as an absolute MADRS total score of ≤10 at the end of treatment
Time frame: at week 2,4and 6
Change of total score of HDRS-17
HDRS-17: Hamilton Depression Rating Scale-17 item
Time frame: from baseline to end of treatment
Change of total score of CGI-S
CGI-S: Clinical Global Impression-Severity Score
Time frame: from baseline to end of treatment
Change of total score of IFS
IFS: Iowa Fatigue Scale
Time frame: from baseline to end of treatment
Change of total score of SDS
SDS: Sheehan Disability Scale
Time frame: from baseline to end of treatment
Patients' ratio who have have scored 1 or 2 in the score of CGI-Improvement
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CGI-I: Clinical Global Impression-Improvement Score
Time frame: at the end of treatment