Abstract
Objective: To examine characteristics of placebo responders and seek optimal criteria of early improvement with placebo for predicting subsequent placebo response in patients with schizophrenia. Method: Data of 672 patients with schizophrenia randomized to placebo in nine double-blind antipsychotic trials were analyzed. Multiple logistic regression analyses were conducted to examine associations between placebo response at week 6 (i.e., a ≥ 25% reduction in the Positive and Negative Syndrome Scale [PANSS] score) and gender, age, study locations, baseline PANSS total or Marder 5-Factor scores, and per cent PANSS score reduction at week 1. Predictive power of improvement at week 1 for subsequent response was investigated; sensitivity and specificity of incremental 5% cutoff points between 5% and 25% reduction in the PANSS total score at week 1 were calculated. Results: Per cent PANSS total score reduction at week 1 and lower PANSS Marder disorganized thought scores at baseline were significantly associated with subsequent placebo response. A 10% reduction in a per-protocol analysis or a 15% reduction in last-observation-carried-forward analysis in the PANSS total score at week 1 showed the highest predictive power. Conclusion: These findings are informative to identify potential placebo responders at the earliest opportunity for optimal trial design for schizophrenia.
| Original language | English |
|---|---|
| Journal | Acta Psychiatrica Scandinavica |
| DOIs | |
| Publication status | Accepted/In press - 2018 Jan 1 |
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Keywords
- antipsychotic agents
- placebo effect
- placebos
- schizophrenia
ASJC Scopus subject areas
- Psychiatry and Mental health
Cite this
Placebo effects in adult and adolescent patients with schizophrenia : combined analysis of nine RCTs. / Kubo, Kenichiro; Fleischhacker, W. W.; Suzuki, T.; Yasui-Furukori, N.; Mimura, Masaru; Uchida, Hiroyuki.
In: Acta Psychiatrica Scandinavica, 01.01.2018.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Placebo effects in adult and adolescent patients with schizophrenia
T2 - combined analysis of nine RCTs
AU - Kubo, Kenichiro
AU - Fleischhacker, W. W.
AU - Suzuki, T.
AU - Yasui-Furukori, N.
AU - Mimura, Masaru
AU - Uchida, Hiroyuki
PY - 2018/1/1
Y1 - 2018/1/1
N2 - Objective: To examine characteristics of placebo responders and seek optimal criteria of early improvement with placebo for predicting subsequent placebo response in patients with schizophrenia. Method: Data of 672 patients with schizophrenia randomized to placebo in nine double-blind antipsychotic trials were analyzed. Multiple logistic regression analyses were conducted to examine associations between placebo response at week 6 (i.e., a ≥ 25% reduction in the Positive and Negative Syndrome Scale [PANSS] score) and gender, age, study locations, baseline PANSS total or Marder 5-Factor scores, and per cent PANSS score reduction at week 1. Predictive power of improvement at week 1 for subsequent response was investigated; sensitivity and specificity of incremental 5% cutoff points between 5% and 25% reduction in the PANSS total score at week 1 were calculated. Results: Per cent PANSS total score reduction at week 1 and lower PANSS Marder disorganized thought scores at baseline were significantly associated with subsequent placebo response. A 10% reduction in a per-protocol analysis or a 15% reduction in last-observation-carried-forward analysis in the PANSS total score at week 1 showed the highest predictive power. Conclusion: These findings are informative to identify potential placebo responders at the earliest opportunity for optimal trial design for schizophrenia.
AB - Objective: To examine characteristics of placebo responders and seek optimal criteria of early improvement with placebo for predicting subsequent placebo response in patients with schizophrenia. Method: Data of 672 patients with schizophrenia randomized to placebo in nine double-blind antipsychotic trials were analyzed. Multiple logistic regression analyses were conducted to examine associations between placebo response at week 6 (i.e., a ≥ 25% reduction in the Positive and Negative Syndrome Scale [PANSS] score) and gender, age, study locations, baseline PANSS total or Marder 5-Factor scores, and per cent PANSS score reduction at week 1. Predictive power of improvement at week 1 for subsequent response was investigated; sensitivity and specificity of incremental 5% cutoff points between 5% and 25% reduction in the PANSS total score at week 1 were calculated. Results: Per cent PANSS total score reduction at week 1 and lower PANSS Marder disorganized thought scores at baseline were significantly associated with subsequent placebo response. A 10% reduction in a per-protocol analysis or a 15% reduction in last-observation-carried-forward analysis in the PANSS total score at week 1 showed the highest predictive power. Conclusion: These findings are informative to identify potential placebo responders at the earliest opportunity for optimal trial design for schizophrenia.
KW - antipsychotic agents
KW - placebo effect
KW - placebos
KW - schizophrenia
UR - http://www.scopus.com/inward/record.url?scp=85052911402&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85052911402&partnerID=8YFLogxK
U2 - 10.1111/acps.12960
DO - 10.1111/acps.12960
M3 - Article
C2 - 30198163
AN - SCOPUS:85052911402
JO - Acta Psychiatrica Scandinavica
JF - Acta Psychiatrica Scandinavica
SN - 0001-690X
ER -