Dose-response across antipsychotics, including amisulpride

“Sixty-eight studies met the inclusion criteria.” (opens the source at this quote in a new tab)
“The 95% effective doses and the doses equivalent to 1 mg of oral risperidone, respectively, were as follows: amisulpride for patients with positive symptoms, 537 mg/day and 85.8 mg” (opens the source at this quote in a new tab)
“In chronic schizophrenia patients with acute exacerbations, doses higher than the identified 95% effective doses may on average not provide more efficacy.” (opens the source at this quote in a new tab)

LB-102 dose groups in NOVA-1

“LB-102 50 mg and 75 mg, were statistically superior to placebo in change from baseline to week 4 in PANSS total score (mean [SE], placebo, −9.3 [1.08]; 50 mg, −14.3 [1.10], P < .001; Hedges g = 0.61; 75 mg, −14.0 [1.11], P = .002; Hedges g = 0.41); LB-102 100 mg, also showed significance (mean [SE], −16.1 [1.91]; nominal P = .002; Hedges g = 0.83).” (opens the source at this quote in a new tab)
“LB-102 100 mg prespecified to have a lower randomized enrollment, demonstrated a nominally significant treatment effect compared with placebo on the primary endpoint, with a numerically larger effect size (Hedges g = 0.83) when compared with the 50-mg (Hedges g = 0.61) or 75-mg (Hedges g = 0.41) doses.” (opens the source at this quote in a new tab)

Baseline symptom severity

“The greater the baseline severity was, the greater the magnitude of the differences was between active treatment and placebo.” (opens the source at this quote in a new tab)
“In acute treatment, the mean differences in PANSS change scores were 9.5 points for patients who were mildly ill at baseline (baseline PANSS score of 58), 13.7 for moderately ill patients (baseline PANSS score of 75), 18.8 for markedly ill patients (baseline PANSS score of 95), and 24.0 for severely ill patients (baseline PANSS score of 116).” (opens the source at this quote in a new tab)
“Toward the mildest end of the spectrum, clinicians need to be aware that patients benefit less in terms of symptom improvement but may experience full adverse effects of antipsychotics.” (opens the source at this quote in a new tab)

First-episode compared with multi-episode schizophrenia

“We included 17 studies with a total of 3156 participants.” (opens the source at this quote in a new tab)
“On the average, 81.3%/51.9% of the first-episode patients reached an at least 20%/50% PANSS or BPRS reduction from baseline, respectively.” (opens the source at this quote in a new tab)
“Meta-regressions revealed a better treatment response in female patients, in more severely ill patients at baseline, in antipsychotic naïve patients, in patients with a shorter illness duration and in open studies.” (opens the source at this quote in a new tab)

Early non-response as a predictor of later non-response

“In 34 studies (N=9,460) a <20% PANSS or BPRS reduction at week 2 predicted nonresponse at endpoint with a specificity of 86% and a positive predictive value (PPV) of 90%.” (opens the source at this quote in a new tab)
“Patients not even minimally improved by week 2 of antipsychotic treatment are unlikely to respond later and may benefit from a treatment change.” (opens the source at this quote in a new tab)

Sex: registration trials of antipsychotics

“The number needed to treat (NNT) for a response in women was 6.9, in men 9.4.” (opens the source at this quote in a new tab)
“Despite the impact of gender and age on effect size in acute antipsychotic treatment, efficacy was clinically relevant in all subgroups.” (opens the source at this quote in a new tab)

Sex: individual participant data from fixed-dose trials

“There was no evidence of sex differences in drug effects on overall symptoms (difference of standardised mean difference [DoSMD] 0·04, 95% CI -0·09 to 0·18).” (opens the source at this quote in a new tab)
“Prolactin increase was greater in females (DoSMD 0·83, 0·67-0·99; high credibility)” (opens the source at this quote in a new tab)

Race and ethnicity

“In the complete data-set, 61% of patients were White, 25.6% of patients were Black and 13.4% of patients were of other ethnicities.” (opens the source at this quote in a new tab)
“Atypical antipsychotic medication is equally effective in both Black and White patients with schizophrenia.” (opens the source at this quote in a new tab)

“Many sites had a trial population that was predominantly Black, reflecting the urban US clinical settings in which recruitment for many sites occurred.” (opens the source at this quote in a new tab)

Age and predominant negative symptoms: amisulpride

“Nevertheless, amisulpride was significantly superior to placebo in older patients (≥60 years of age; SMD 0·86) and in patients with predominant negative symptoms (SMD 0·47).” (opens the source at this quote in a new tab)

Moderators of metabolic adverse effects

“Greater increases in glucose were predicted by higher baseline weight (p=0·0015) and male sex (p=0·0082).” (opens the source at this quote in a new tab)
“Non-white ethnicity was associated with greater increases in total cholesterol (p=0·040) compared with white ethnicity.” (opens the source at this quote in a new tab)

Sex and treatment resistance

“Men were 1.57 times more likely to develop TRS than women (95% CI 1.11-2.21, P = 0.010).” (opens the source at this quote in a new tab)

Trial-level moderators of drug-placebo differences

“However, in a multivariable meta-regression, only industry sponsorship and increasing placebo response were significant moderators of effect sizes.” (opens the source at this quote in a new tab)

NOVA-1 subgroup analyses by sex, race, age, or baseline severity

No evidence found.