title: Aripiprazole augmentation for treatment of patients with chronic or recurrent major depressive disorder: a 12-week prospective open-label multicentre study.
abstract: 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.
authors.affiliation: 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.
authors.forename: Chi-Un
authors.initials: CU
authors.lastname: Pae
authors.forename: Hong Jin
authors.initials: HJ
authors.lastname: Jeon
authors.forename: Boung Chul
authors.initials: BC
authors.lastname: Lee
authors.forename: Ho-Jun
authors.initials: HJ
authors.lastname: Seo
authors.forename: Shin Gyeom
authors.initials: SG
authors.lastname: Kim
authors.forename: E-Jin
authors.initials: EJ
authors.lastname: Park
authors.forename: Won
authors.initials: W
authors.lastname: Kim
authors.forename: Kyung-Phil
authors.initials: KP
authors.lastname: Kwak
authors.forename: Changsu
authors.initials: C
authors.lastname: Han
authors.forename: Seong-Jin
authors.initials: SJ
authors.lastname: Cho
authors.forename: Sang-Woo
authors.initials: SW
authors.lastname: Hahn
authors.forename: Duk-In
authors.initials: DI
authors.lastname: Jon
authors.forename: Jin-Hyuk
authors.initials: JH
authors.lastname: Choi
authors.forename: Tae-Youn
authors.initials: TY
authors.lastname: Jun
mesh_terms: D000328:Adult; D000928:Antidepressive Agents / Q000008:administration & dosage*; D000068180:Aripiprazole; D002908:Chronic Disease; D003865:Major Depressive Disorder / Q000175:diagnosis* / Q000188:drug therapy* / Q000523:psychology; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000008:administration & dosage*; D011446:Prospective Studies; D015363:Quinolones / Q000008:administration & dosage*; D055502:Secondary Prevention; D016896:Treatment Outcome
chemical_list: D000928:Antidepressive Agents; D010879:Piperazines; D015363:Quinolones; D000068180:Aripiprazole