STARD Phase 2- Augmentation

PICO question: In adult patients (P) with nonpsychotic depression not alleviated with SSRI monotherapy, does augmentation with another agent (I) affect remission rates (O). No Control (C)
Citation: NEJM 2006:354:12, Trivedi et al., Medication Augmentation after failure of SSRIs for depression.


Design: Phase 2 STAR*D prospective sequentially randomized control trial.
Follow up period: 2, 4, 6, 8, 10, & 12 weeks
Setting: Adult outpatients from multiple sites (23 psychiatric &18 primary care) with nonpsychotic depression nonremitted on citalopram at mean dose of 55 mg daily and mean duration of 11.9 weeks.
Participants: Inclusion criteria: 18-75 yo, Primary nonpsychotic MDD (HAM-D ≥14) Exclusion criteria: Pregnant/breast feeding, medical contraindications, substance dependence requiring inpatient detox, and history of nonresponse.
Intervention: First Arm – Bupropion SR up to 400 mg daily; Second Arm – Buspirone up to 60 mg daily
Outcome measures:
-Primary – remission defined as HAMD ≤7
-Secondary - remission defined as QIDS-SR <6 and response defined as ≥50% reduction from baseline.
-HRSD-17 remission rates: Buproprion SR (29.7 %) vs. Buspirone (30.1%)
-QIDS-SR-16 remission rates: Buproprion SR (39%) vs. Buspirone (32.9%)
-QIDS-SR-16 response rates: Buproprion SR (31.8%) vs. Buspirone (26.9%)
-QIDS-SR-16 reduction from baseline: Buproprion SR (25.3%) vs. Buspirone (17.1%); Cohen d = 0.201
-Dropout rate: Buproprion SR (12.5%) vs. Buspirone (20.6%)

Strengths: real world trial, well implemented trial of monotherapy, good generalizability, large sample size,
Weaknesses: no control, unblinded delivery of treatment, telephone interviews, baseline duration of illness differences

Validity crtieria:

Was follow up adequate? Yes
Were the participants randomized? Yes
Was allocation concealed? NR
Intention to treat? Yes
Were the groups similar at baseline? Yes
Were pts, MDs and analysts blinded? No
Were the groups treated equally? Yes
Was there an a priori hypothesis? Yes
Were the outcome clearly defined? Yes
Did they use validated measurements? Yes
Was the placebo/control appropriate? No
Were side effects discussed? Yes
Is the effect clinically important? No
Is this congruent with existing studies? N/A
Is this feasible in your setting? Yes
Were the investigators independent? No
Will this change your current practice? No

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