STARD Phase 1

PICO question: In adult Patients with nonpsychotic major depression when treated with an SSRI (Intervention) what is the rate of remission (Outcome) and what are the baseline predictors of remission.

Citation: AJP 2006:163:28-40 Trivedi et al


Methods: Design: STAR*D Prospective sequentially randomized control trial. This level is an open label study . Follow up period: Upto 14 weeks to treatment or time to drop out/go onto next level. Stimulants, anticonvulsants, antipsychotics, alprazolam, other antidepressants were avoided.
Setting: Multiple site (23 psychiatric &18 primary care)
Participants: Inclusion criteria: 18-75, Primary nonpsychotic MDD (HAM-D ≥14) Exclusion criteria: Pregnant/breast feeding, medical contraindications, substance dep requiring inpatient detox, h/o nonresponse /intolerance to study meds (1st 2 steps).
Intervention: Citalopram flexibly dosed b/w 10-60mg and measurement-based care
(5 baseline visits ±1). Treatment manual, centralized feedback
Outcome measures: Remission (HAMD ≤7/ QIDS-SR ≤5)
Response (≥50% reduction). Baseline characteristics associated with remission

Results:
-Remission rate for HAMD 28% and for QIDS-SR 33%. Response rate 47%.(QID-SR)
-Lower remission if unemloyed, lower income, non-Caucasian, male, less educated,
poorer function and lower quality of life at baseline.
-Greater illness severity, psychiatric and medical comorbidity and poor social support
are associated with lower rates of remission.
-Of participants who responded 56.0% did so after 8 weeks of treatment.

Strengths: Large sample, generalizable, resmission as outcome is clinically revelant, good follow up.
Weaknesses: No placebo control so hard to draw conclusions, authors did have affiliation to pharma which might be significant for the later studies in this trial, no correction for multiple comparsions makes it hard to interpret the many tables

Validity Criteria

Was follow up adequate? Yes
Were the participants randomized? No
Was allocation concealed? N/A
Intention to treat? No
Were the groups similar at baseline? N/A
Were pts, MDs and analysts blinded? No
Were the groups treated equally? N/A
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 control
Were side effects discussed? Yes
Is the effect clinically important? Yes
Is this congruent with existing studies? Yes
Is this feasible in your setting? Yes
Were the investigators independent? ±
Will this change your current practice? Yes

 

end fo content area