DESIGN:
- Multisite randomized, single-blind, parallel-assignment trial.
INCLUSION CRITERIA:
- Suboptimal response to SSRI, SNRI or Mirtazapine.
- Suboptimal response = QIDS-C16 score of >16 (after 6 weeks of treatment) or >11 (after 8 weeks of treatment) with 3 most recent weeks at stable “optimal” dose.
QIDS-C16 = 16-Item Quick Inventory of Depressive Symptomatology-Clinician Rated.
EXCLUSION CRITERIA:
- current treatment with bupropion or any antipsychotic.
- history of bipolar disorder, schizophrenia, schizoaffective disorder, or other psychosis.
- current dementia
- eating disorder
- seizure disorder
- suicidal ideation requiring inpatient treatment
- unstable medical condition
- need of immediate psychiatric hospitalization
- substance dependence requiring detoxification in the past 30 days
- pregnant, lactating, or planning to become pregnant
- unable or unwilling to provide informed consent or declined to participate prior to randomization.
RANDOMIZATION: to one of the three treatment:-
- SWITCH GROUP: switch to bupropion sustained release.
- AUGMENT-BUPROPION GROUP: augment current treatment with bupropion sustained release.
- AUGMENT- ARIPIPRAZOLE GROUP: augment current treatment with aripiprazole.
DOSE OF MEDICATIONS USED:
- SWITCH GROUP: dose of bupropion reached max of 200 mg twice daily by 6 weeks and remained at that level through 12 weeks.
- AUGMENT-BUPROPION GROUP: also reached max of 200 mg twice daily by 6 weeks.
- AUGMENT- ARIPIPRAZOLE GROUP: dose of aripiprazole was 5 mg daily from weeks 2 through 10 and reached 10 mg daily at week 12.
RESULTS:
(1) Remission rates at 12 weeks: Higher for Aripiprazole augmentation.
- Switch group: 22.3% (n = 114)
- Augment- bupropion group: 26.9% (n = 136)
- Augment- aripiprazole group: 28.9% (n = 146)
(2) Response rate:Higher for Aripiprazole augmentation.
- Switch group: 62.4%
- Augment- bupropion group: 65.6%
- Augment- aripiprazole group: 74.3%
(3) Side Effect Profile:
(A) Anxiety was more frequent in the bupropion augmentation group.
- Switch group: 24.3%
- Augment- bupropion group: 22.5%
- Augment- aripiprazole group: 16.6%
(B) Adverse effects more frequent in the augment-aripiprazole group included
- somnolence,
- akathisia, and
- weight gain.
CONCLUSIONS:
Augmentation with aripiprazole resulted in a statistically significant but only modestly increased likelihood of remission during 12 weeks of treatment compared with switching to bupropion monotherapy.