Negative results from a randomized controlled trial of olanzapine for psychosis in Parkinson disease: data, CONSORT checklist and initial study protocol

CONSORT checklist

Subject characteristics at study entry: S#, subject ID for this study; DRUG, olanzapine dose (mg) this patient took; ADJUST, whether the dose of antiparkinsonian medication was adjusted at the week 2 visit. For remaining columns, the trailing zero in the column heading refers to the score at the baseline (week 0) visit; see Methods section for references. BPRST, BPRS total score; BPRSP, BPRS psychosis items subscore; PDQ, PDQ39 score; BDI, Beck Depression Inventory; HamD, Hamilton Depression Rating Scale; CGIMDo/a, Clinical Global Impression score for overall clinical state as rated by investigator; INS, insomnia score from sleep rating scale; HYPIN, hypersomnia score from sleep rating scale; SEADLS, Schwab-England score; BlindKB, investigator guess at week 4 as to drug assignment; BlindPt., patient guess at week 4 as to drug assignment.

Outcomes other than blinded BPRS ratings: S#, subject ID for this study; DRUG, olanzapine dose (mg) this patient took; ADJUST, whether the dose of antiparkinsonian medication was adjusted at the week 2 visit; change, details of that change; use0-2, analyze this subject’s data in the ANOVA for weeks 0-2; use2-4, analyze this subject’s data in the ANOVA for weeks 2-4; WD, ended study participation early; WDSE, withdrew from study because of side effects; WDnowork, withdrew from study because of lack of benefit; WDcure, withdrew from study because subject pronounced self “cured” after one dose; SAEs, serious adverse events; mild SEs, mild side effects; other, other comments on efficacy or side effects; handed, right- or left-handed. For remaining columns, the trailing numeral in the column heading refers to the score at the visit from week 0, 2, or 4. See Methods section for additional information. VH, visual hallucinations present; AH, auditory hallucinations present; Del, delusions present; BPRST, BPRS total score; BPRSP, BPRS psychosis items subscore; 1UPDRS, UPDRS subscale 1; 2UPDRS, UPDRS subscale 2 (etc.); PDQ, PDQ39 score; BDI, Beck Depression Inventory; HamD, Hamilton Depression Rating Scale; CGI, Clinical Global Impression scale; CGIMD, CGI rated by investigator; CGI…overall, CGI score for overall clinical state; CGIPT, CGI rated by patient; CGI…hall, CGI for hallucinations; CGI…improve, CGI improvement from study initiation; INS, insomnia score from sleep rating scale; BlindJH, study RN guess at week 4 as to drug assignment; BlindKB, investigator guess at week 4 as to drug assignment; BlindKBdrug, same, collapsed to simply olanzapine vs placebo (no dose category); BlindPt., patient guess at week 4 as to drug assignment; BlindBR, guess of study neurologist at week 4 as to drug assignment; 0/5/10, whether this subject was enrolled under the initial study drug assignment (placebo vs 5 or 10mg); HYPIN, hypersomnia score from sleep rating scale; SEADLS, Schwab-England score.

Blinded BPRS ratings from videotape: video ID#, code by which blinded videotape reviewer scored each video segment; BPRS-T, BPRS total score; BPRS-P, BPRS psychosis items subscore.

## CONSORT检查表（CONSORT checklist）

### 研究入组时的受试者特征
S#为本次研究的受试者编号；DRUG为该患者服用的奥氮平剂量（mg）；ADJUST指第2周随访时是否调整了抗帕金森病药物剂量。其余列的列名末尾的数字0代表基线（第0周）随访时的评分，具体参考文献详见方法学章节。
BPRST即简明精神病评定量表（BPRS）总分（BPRS total score）；BPRSP即简明精神病评定量表（BPRS）精神病性条目子评分（BPRS psychosis items subscore）；PDQ即PDQ39量表评分（PDQ score）；BDI即贝克抑郁自评量表（Beck Depression Inventory）；HamD即汉密尔顿抑郁评定量表（Hamilton Depression Rating Scale）；CGIMDo/a即研究者评定的总体临床状态临床整体印象评分（Clinical Global Impression score for overall clinical state as rated by investigator）；INS即睡眠评定量表中的失眠评分（insomnia score from sleep rating scale）；HYPIN即睡眠评定量表中的嗜睡评分（hypersomnia score from sleep rating scale）；SEADLS即施瓦布-英格兰日常生活活动能力评分（Schwab-England score）；BlindKB为第4周随访时研究者对药物分配方案的猜测结果；BlindPt.为第4周随访时患者对药物分配方案的猜测结果。

### 非盲法BPRS评分相关结局指标
S#为本次研究的受试者编号；DRUG为该患者服用的奥氮平剂量（mg）；ADJUST指第2周随访时是否调整了抗帕金森病药物剂量；change为该药物剂量调整的具体细节；use0-2指将该受试者的数据纳入第0-2周的方差分析（Analysis of Variance，简称ANOVA）；use2-4指将该受试者的数据纳入第2-4周的方差分析（ANOVA）；WD指受试者提前终止研究参与；WDSE指因不良反应退出研究；WDnowork指因疗效不佳退出研究；WDcure指受试者在服用1剂药物后自认为“痊愈”而退出研究；SAEs即严重不良事件（serious adverse events）；mild SEs即轻度不良反应；other指疗效或不良反应相关的其他评论；handed指受试者的利手类型（右利或左利）。其余列的列名末尾的数字代表第0、2或4周随访时的评分，额外信息详见方法学章节。
VH即视幻觉阳性（visual hallucinations present）；AH即听幻觉阳性（auditory hallucinations present）；Del即妄想阳性（delusions present）；BPRST即简明精神病评定量表（BPRS）总分（BPRS total score）；BPRSP即简明精神病评定量表（BPRS）精神病性条目子评分（BPRS psychosis items subscore）；1UPDRS即统一帕金森病评定量表第1子量表（UPDRS subscale 1）；2UPDRS即统一帕金森病评定量表第2子量表（UPDRS subscale 2，依此类推）；PDQ即PDQ39量表评分（PDQ score）；BDI即贝克抑郁自评量表（Beck Depression Inventory）；HamD即汉密尔顿抑郁评定量表（Hamilton Depression Rating Scale）；CGI即临床整体印象量表（Clinical Global Impression scale）；CGIMD即研究者评定的临床整体印象；CGI…overall即总体临床状态的临床整体印象评分；CGIPT即患者自评的临床整体印象；CGI…hall即针对幻觉症状的临床整体印象评分；CGI…improve即自研究启动以来的临床改善情况评分；INS即睡眠评定量表中的失眠评分（insomnia score from sleep rating scale）；BlindJH为第4周随访时研究护士对药物分配方案的猜测结果；BlindKB为第4周随访时研究者对药物分配方案的猜测结果；BlindKBdrug为上述猜测结果的简化版本，仅分为奥氮平组与安慰剂组（不区分剂量层级）；BlindPt.为第4周随访时患者对药物分配方案的猜测结果；BlindBR为第4周随访时研究神经科医师对药物分配方案的猜测结果；0/5/10指该受试者按照初始研究药物分配方案入组（安慰剂组 vs 5mg或10mg组）；HYPIN即睡眠评定量表中的嗜睡评分（hypersomnia score from sleep rating scale）；SEADLS即施瓦布-英格兰日常生活活动能力评分（Schwab-England score）。

### 录像带盲法BPRS评分
video ID#为盲法录像评分者对每个视频片段进行评分所用的编码；BPRS-T即简明精神病评定量表（BPRS）总分（BPRS total score）；BPRS-P即简明精神病评定量表（BPRS）精神病性条目子评分（BPRS psychosis items subscore）。