Key Takeaways
Extended Takeaways
- The signal in this trial was strongest for negative symptoms: among the subgroup with baseline PANSS negative symptom severity of ≥ 4 on 2 or more items, mean change was 4.22 ± 2.86 with WSE versus 0.25 ± 2.14 with placebo (t19 = 3.65, P = .002), with Cohen d = 1.61, 95% CI = 0.61 to 2.6.
- Clinical separation emerged by 4 weeks, suggesting psychiatrists should not expect an immediate effect from adjunctive WSE but may see benefit by the first month if the patient is responding.
- Adjunctive WSE was associated with fewer antipsychotic treatment escalations during exacerbation management: 2 (6.1%) WSE-treated subjects had an antipsychotic dosage increase versus 9 (27.3%) in the placebo group, including 1 placebo patient who required addition of a second antipsychotic drug (Fisher exact P = .044).
- Despite the anti-inflammatory rationale, biomarker changes did not track with symptom improvement in this sample: hsCRP declined by 1.08 (6.98) mg/L with WSE versus an increase of 1.55 (5.58) mg/L with placebo (P = .25), and S100b declined by 12.98 (112.89) pg/mL versus an increase of 27.54 (145.41) pg/mL (P = .72).
- Tolerability was generally favorable over 12 weeks, with no significant between-group differences in weight, vital signs, ECGs, or laboratory measures; the adverse effects occurring more often with WSE were somnolence (21.1%), loose stool/diarrhea (18.1%), and epigastric discomfort/stomach pain (9.1%).
- This study targeted outpatients with recent symptom worsening rather than chronic stable illness, with entry requiring PANSS total score had to be ≥ 60 and exacerbation lasting ≥ 2 weeks but ≤ 1 year, so applicability is best for schizophrenia or schizoaffective disorder patients in an active exacerbation phase.
