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Aripiprazole augmentation for treatment of patients with chronic or recurrent major depressive disorder: a 12-week prospective open-label multicentre study

Pae, Chi-Una,k; Jeon, Hong Jinb; Lee, Boung Chulc; Seo, Ho-Juna; Kim, Shin Gyeomd; Park, E-Jina; Kim, Wone; Kwak, Kyung-Philg; Han, Changsuf; Cho, Seong-Jinh; Hahn, Sang-Wood; Jon, Duk-Ini; Choi, Jin-Hyukj; Jun, Tae-Youna

International Clinical Psychopharmacology: November 2013 - Volume 28 - Issue 6 - p 322–329
doi: 10.1097/YIC.0b013e3283643728
Original Articles

Patients with chronic or recurrent major depressive disorder (MDD) have faced a dearth of treatment options. The present study evaluated the effectiveness and tolerability of aripiprazole augmentation for the treatment of chronic or recurrent MDD. This was the first 12-week prospective, multicentre, open-label study of the effectiveness and tolerability of flexibly dosed aripiprazole as an augmentation to ongoing antidepressant treatment in patients with chronic or recurrent MDD. The primary outcome measure for effectiveness was changes between baseline and endpoint (week 12) in total scores on the Montgomery–Asberg Depression Rating Scale. Adverse events (AEs) occurring throughout the trial are also reported. The Montgomery–Asberg Depression Rating Scale total scores decreased significantly between the baseline and the endpoint (magnitude of difference=−11.6, P<0.0001). At the endpoint, the response rate was 55.2% and the remission rate was 41.3%. Adjunctive aripiprazole treatment administered from week 1 through the endpoint was associated with remission and significant treatment responses. More than half (55.8%) of those taking adjunctive aripiprazole completed the study and relatively few patients discontinued participation because of AEs. None of the patients discontinued participation in the study because of an inadequate therapeutic response. Common AEs included headache, akathisia, insomnia and constipation. The mean dose of aripiprazole at the endpoint was 6.6 mg/day. Adjunctive aripiprazole may be effective and tolerable for patients with chronic or recurrent MDD. Adequately powered and controlled clinical trials should be conducted to confirm our open-label study findings.

aDepartment of Psychiatry, College of Medicine, The Catholic University of Korea

bDepartment of Psychiatry, Samsung Medical Center, School of Medicine, Sungkyunkwan University

cDepartment of Neuropsychiatry, College of Medicine, Hallym University

dDepartment of Psychiatry, Soonchunhyang University

eDepartment of Psychiatry, College of Medicine, Inje University

fDepartment of Psychiatry, College of Medicine, Korea University, Seoul

gDepartment of Neuropsychiatry, School of Medicine, Dongguk University, Gyeongju

hDepartment of Psychiatry, Gill Hospital, Gachon University of Medicine and Science, Incheon

iDepartment of Psychiatry, College of Medicine, Hallym University, Chuncheon

jDepartment of Psychiatry, Bongsaeg Hospital, Pusan, Republic of Korea

kDepartment of Psychiatry and Behavioral Sciences, Duke University Medical Center, Duram, North Carolina, USA

Correspondence to Chi-Un Pae, MD, Department of Psychiatry, Bucheon St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, 2 Sosa-Dong, Wonmi-Gu, Bucheon 420717, Kyeonggi-Do, Republic of Korea Tel: +82 32 340 7067; fax: +82 32 340 2255; e-mail:

Received April 1, 2013

Accepted June 13, 2013

© 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins