title: Pilot study of augmentation with aripiprazole for incomplete response in late-life depression: getting to remission.
abstract: OBJECTIVE
  To determine the feasibility and safety of aripiprazole augmentation for incomplete response to sequential selective serotonin reuptake inhibitor (SSRI) and serotonin-norepinephrine reuptake inhibitor (SNRI) pharmacotherapy in late-life depression.
  
  
  METHODS
  This study was a 12-week, open-label pilot study of 24 patients (recruited from June 1, 2006, to June 1, 2007) aged 65 years and above (mean, 73.9 years) diagnosed with major depressive disorder (MDD) (according to DSM-IV) who responded partially (17-item Hamilton Rating Scale for Depression [HAM-D-17] score of 11 to 15) or not at all (HAM-D score > 15) to a 16-week trial of escitalopram (up to 20 mg/day), followed by either duloxetine (up to 120 mg/day) or venlafaxine (up to 225 mg/day) for 12 weeks. Subjects received 2.5 to 15 mg per day of adjunctive aripiprazole (mean dose, 9.0 mg/day) for 12 weeks. The criterion for remission during treatment with aripiprazole was a HAM-D score < or = 10 for 2 consecutive weeks.
  
  
  RESULTS
  Of 24 subjects in the intent-to-treat study group, 19 completed 12 weeks of augmentation with aripiprazole, 12 of 24 (50%) met criteria for remission, and 2 of 24 discontinued due to side effects (sedation, akathisia). The mean (SD) HAM-D score decreased significantly by 6.4 (5.8) points (paired t test for means, p < .01, df = 16). There were no relapses among the 12 subjects who participated in continuation treatment over a median period of 27.6 weeks.
  
  
  CONCLUSIONS
  In older adults with MDD with incomplete response to SSRI and SNRI pharmacotherapy, aripiprazole was well tolerated, and symptoms of depression improved significantly during treatment with aripiprazole. A randomized, double-blind, placebo-controlled trial of adjunctive aripiprazole for incomplete response in late-life depression is warranted to further evaluate benefit and risk.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00177671.
authors.affiliation: Advanced Center in Interventions and Services Research for Late-Life Mood Disorders (ACISR/LLMD) and the John A Hartford Center of Excellence in Geriatric Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA 15213, USA.
authors.forename: Meera
authors.initials: M
authors.lastname: Sheffrin
authors.forename: Henry C
authors.initials: HC
authors.lastname: Driscoll
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Lenze
authors.forename: Benoit H
authors.initials: BH
authors.lastname: Mulsant
authors.forename: Bruce G
authors.initials: BG
authors.lastname: Pollock
authors.forename: Mark D
authors.initials: MD
authors.lastname: Miller
authors.forename: Meryl A
authors.initials: MA
authors.lastname: Butters
authors.forename: Mary Amanda
authors.initials: MA
authors.lastname: Dew
authors.forename: Charles F
authors.initials: CF
authors.lastname: Reynolds
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000928:Antidepressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000068180:Aripiprazole; D015283:Citalopram / Q000009:adverse effects / Q000627:therapeutic use*; D003511:Cyclohexanols / Q000009:adverse effects / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D000068736:Duloxetine Hydrochloride; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D010555:Personality Inventory; D010865:Pilot Projects; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D015363:Quinolones / Q000009:adverse effects / Q000627:therapeutic use*; D013876:Thiophenes / Q000009:adverse effects / Q000627:therapeutic use*; D000069470:Venlafaxine Hydrochloride
chemical_list: D000928:Antidepressive Agents; D014150:Antipsychotic Agents; D003511:Cyclohexanols; D010879:Piperazines; D015363:Quinolones; D013876:Thiophenes; D015283:Citalopram; D000069470:Venlafaxine Hydrochloride; D000068180:Aripiprazole; D000068736:Duloxetine Hydrochloride