Pilot study of augmentation with aripiprazole for incomplete response in late-life depression: getting to remission.
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.
Sheffrin
Meera
M
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.
Driscoll
Henry C
HC
Lenze
Eric J
EJ
Mulsant
Benoit H
BH
Pollock
Bruce G
BG
Miller
Mark D
MD
Butters
Meryl A
MA
Dew
Mary Amanda
MA
Reynolds
Charles F
CF
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
D000928:Antidepressive Agents; D014150:Antipsychotic Agents; D003511:Cyclohexanols; D010879:Piperazines; D015363:Quinolones; D013876:Thiophenes; D015283:Citalopram; D000069470:Venlafaxine Hydrochloride; D000068180:Aripiprazole; D000068736:Duloxetine Hydrochloride