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临床试验/NCT00772005
NCT00772005已完成2 期

A 24-Week, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil (150, 200, and 250 mg/ Day) as Adjunctive Therapy in Adults With Schizophrenia

Cephalon39 个研究点 分布在 1 个国家目标入组 287 人开始时间: 2008年9月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
287
试验地点
39
主要终点
Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Endpoint
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary objective of the study is to evaluate whether armodafinil treatment is more effective than placebo as adjunctive therapy to antipsychotic medication in alleviating the negative symptoms of schizophrenia

详细描述

This study was designed and was powered to evaluate the efficacy and safety of armodafinil treatment at dosages of 150, 200, and 250 mg/day compared with placebo over 24 weeks as an adjunctive therapy to antipsychotic medication (olanzapine, oral risperidone, or paliperidone) in adults with schizophrenia who were clinically stable at study entry. Specifically, the effects of armodafinil treatment on the negative symptoms of schizophrenia were the primary assessment in this study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •The patient has a diagnosis of schizophrenia according to the DSM-IV-TR criteria and the patient has been clinically stable in a nonacute phase of their illness.
  • •Documentation that the patient has received treatment with olanzapine, oral risperidone, or paliperidone for schizophrenia for at least 6 weeks prior to the screening visit and has been on a stable dose of that antipsychotic medication for at least 4 weeks prior to the screening visit.
  • •The patient is in good health (except for the diagnosis of schizophrenia) as judged by the investigator.
  • •Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception include barrier method with spermicide, intrauterine device (IUD), steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method, or documented abstinence.
  • •The patient has a PANSS negative symptom score of 15 or more at the screening and baseline visits.

排除标准

  • •The patient has a severity rating of moderate or worse on any item of the PANSS positive symptom subscale.
  • •The patient has any Axis I disorder according to DSM-IV-TR criteria, including schizoaffective disorder, apart from schizophrenia and nicotine dependence, or any Axis II disorder that would interfere with the conduct of the study.
  • •The patient has moderate to severe depressive symptoms, as indicated by the CDSS.
  • •The patient has current active suicidal ideation, is at imminent risk of self-harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present.
  • •The patient has tardive dyskinesia, akathisia, moderate or worse level of extrapyramidal symptoms, or any other clinically significant movement disorder.
  • •The patient has a history of any cutaneous drug reaction or drug hypersensitivity reaction, a history of any clinically significant hypersensitivity reaction, or has a history of multiple clinically relevant allergies.
  • •The patient is a pregnant or lactating woman.
  • •The patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets.

研究组 & 干预措施

150 mg/day armodafinil

Active Comparator

At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.

干预措施: armodafinil (Drug)

200 mg/day armodafinil

Active Comparator

At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.

干预措施: armodafinil (Drug)

250 mg/day armodafinil

Active Comparator

At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.

干预措施: armodafinil (Drug)

Matching Placebo

Placebo Comparator

At the baseline visit, patients were randomly assigned to 1 of 3 armodafinil treatment groups or to the placebo treatment group. Patients took 5 tablets orally each day, once daily in the morning. Study drug was titrated (using blister cards) during the double-blind treatment period starting with 50 mg/day of armodafinil or matching placebo. The dosage of armodafinil or matching placebo tablet was increased, as applicable, by 50 mg/day on days 2, 4, 6, and 8, up to the randomized dosage of 150, 200, or 250 mg/day. Patients remained at their randomized dosage for the duration of the study.

干预措施: placebo (Drug)

结局指标

主要结局

Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Endpoint

时间窗: Baseline and Endpoint (Week 24 or last observation after baseline)

PANSS rates severity of psychopathology in schizophrenics. 7 items measure NEGATIVE symptoms: blunted affect, social withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking. Each item is scored on a 7-point severity scale: 1=absent, 2=minimal, 3=mild, 4=moderate, 5=moderate severe, 6=severe, 7=extreme. Negative Scale score ranges from 7-49 (higher more severe). Data represents change in Negative Rating Scale from baseline to endpoint with positive scores indicating more severe pathology.

次要结局

  • Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Endpoint(Baseline and Endpoint (Week 24 or last observation after baseline))
  • Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 1(Baseline and Week 1)
  • Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 2(Baseline and Week 2)
  • Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 4(Baseline and Week 4)
  • Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 8(Baseline and Week 8)
  • Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 12(Baseline and Week 12)
  • Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 16(Baseline and Week 16)
  • Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 20(Baseline and Week 20)
  • Mean Change in Total Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 24(Baseline and Week 24)
  • Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 1(Baseline and Week 1)
  • Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 2(Baseline and Week 2)
  • Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 4(Baseline and Week 4)
  • Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 8(Baseline and Week 8)
  • Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 12(Baseline and Week 12)
  • Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 16(Baseline and Week 16)
  • Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 20(Baseline and Week 20)
  • Mean Change in Negative Scale Scores From the Positive and Negative Syndrome Scale (PANSS) From Baseline to Week 24(Baseline and Week 24)
  • Mean Change From Baseline to Endpoint in the Positive and Negative Syndrome Scale(PANSS) Positive Scale Score(Baseline and Endpoint (Week 24 or last observation))
  • Mean Change From Baseline to Week 1 in the Positive and Negative Syndrome Scale (PANSS)Positive Scale Score(Baseline and Week 1)
  • Mean Change From Baseline to Week 2 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score(Baseline and Week 2)
  • Mean Change From Baseline to Week 4 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score(Baseline and Week 4)
  • Mean Change From Baseline to Week 8 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score(Baseline and Week 8)
  • Mean Change From Baseline to Week 12 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score(Baseline and Week 12)
  • Mean Change From Baseline to Week 16 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score(Baseline and Week 16)
  • Mean Change From Baseline to Week 20 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score(Baseline and Week 20)
  • Mean Change From Baseline to Week 24 in the Positive and Negative Syndrome Scale (PANSS) Positive Scale Score(Baseline and Week 24)
  • Mean Change From Baseline to Endpoint on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score(Baseline and Endpoint (Week 24 or last observation after baseline))
  • Mean Change From Baseline to Week 1 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score(Baseline and Week 1)
  • Mean Change From Baseline to Week 2 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score(Baseline and Week 2)
  • Mean Change From Baseline to Week 4 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score(Baseline and Week 4)
  • Mean Change From Baseline to Week 8 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score(Baseline and Week 8)
  • Mean Change From Baseline to Week 12 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score(Baseline and Week 12)
  • Mean Change From Baseline to Week 16 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score(Baseline and Week 16)
  • Mean Change From Baseline to Week 20 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score(Baseline and Week 20)
  • Mean Change From Baseline to Week 24 on the Positive and Negative Syndrome Scale (PANSS) General Psychopathology Scale Score(Baseline and Week 24)
  • Mean Change From Baseline to Endpoint From Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)(Baseline and Endpoint (Week 24 or last observation))
  • Mean Change From Baseline to Week 1 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 1)
  • Mean Change From Baseline to Week 2 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 2)
  • Mean Change From Baseline to Week 4 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 4)
  • Mean Change From Baseline to Week 8 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 8)
  • Mean Change From Baseline to Week 12 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 12)
  • Mean Change From Baseline to Week 16 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 16)
  • Mean Change From Baseline to Week 20 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 20)
  • Mean Change From Baseline to Week 24 of Negative Symptom Dimension Scores From the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 24)
  • Mean Change From Baseline to Endpoint of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Endpoint (Week 24 or last observation))
  • Mean Change From Baseline to Week 1 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 1)
  • Mean Change From Baseline to Week 2 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 2)
  • Mean Change From Baseline to Week 4 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 4)
  • Mean Change From Baseline to Week 8 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 8)
  • Mean Change From Baseline to Week 12 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 12)
  • Mean Change From Baseline to Week 16 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 16)
  • Mean Change From Baseline to Week 20 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 20)
  • Mean Change From Baseline to Week 24 of Positive Symptom Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 24)
  • Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test(Baseline and Week 12)
  • Mean Change From Baseline to Endpoint From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Endpoint (Week 24 or last observation))
  • Mean Change From Baseline to Week 1 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 1)
  • Mean Change From Baseline to Week 2 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 2)
  • Mean Change From Baseline to Week 4 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 4)
  • Mean Change From Baseline to Week 8 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 8)
  • Mean Change From Baseline to Week 12 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 12)
  • Mean Change From Baseline to Week 16 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 16)
  • Mean Change From Baseline to Week 20 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 20)
  • Mean Change From Baseline to Week 24 From Anxiety/Depression Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 24)
  • Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test(Baseline and Week 24)
  • Mean Change From Baseline to Endpoint From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Endpoint (Week 24 or last observation))
  • Mean Change From Baseline to Week 1 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 1)
  • Mean Change From Baseline to Week 2 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 2)
  • Mean Change From Baseline to Week 4 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 4)
  • Mean Change From Baseline to Week 8 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 8)
  • Mean Change From Baseline to Week 12 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 12)
  • Mean Change From Baseline to Week 16 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 16)
  • Mean Change From Baseline to Week 20 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 20)
  • Mean Change From Baseline to Week 24 From Disorganized Thought Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 24)
  • Mean Change From Baseline to Endpoint From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Endpoint (Week 24 or last observation))
  • Mean Change From Baseline to Week 1 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 1)
  • Mean Change From Baseline to Week 2 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 2)
  • Mean Change From Baseline to Week 4 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 4)
  • Mean Change From Baseline to Week 8 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 8)
  • Mean Change From Baseline to Week 12 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 12)
  • Mean Change From Baseline to Week 16 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 16)
  • Mean Change From Baseline to Week 20 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 20)
  • Mean Change From Baseline to Week 24 From the Hostility/Excitement Dimension of the Positive and Negative Syndrome Scale (PANSS)(Baseline and Week 24)
  • Change From Baseline to Endpoint in the Clinical Global Impression of Severity of Illness (CGI-S) Rating(Baseline and Endpoint (Week 24 or last observation))
  • Change From Baseline to Week 1 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating(Baseline and Week 1)
  • Change From Baseline to Week 2 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating(Baseline and Week 2)
  • Change From Baseline to Week 4 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating(Baseline and Week 4)
  • Change From Baseline to Week 6 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating(Baseline and Week 6)
  • Change From Baseline to Week 8 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating(Baseline and Week 8)
  • Change From Baseline to Week 10 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating(Baseline and Week 10)
  • Change From Baseline to Week 12 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating(Baseline and Week 12)
  • Change From Baseline to Week 14 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating(Baseline and Week 14)
  • Change From Baseline to Week 16 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating(Baseline and Week 16)
  • Change From Baseline to Week 18 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating(Baseline and Week 18)
  • Change From Baseline to Week 20 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating(Baseline and Week 20)
  • Change From Baseline to Week 22 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating(Baseline and Week 22)
  • Change From Baseline to Week 24 in the Clinical Global Impression of Severity of Illness (CGI-S) Rating(Baseline and Week 24)
  • Mean Change From Baseline to Endpoint in Personal and Social Performance Scale (PSP) Scores(Baseline and Endpoint (Week 24 or last observation))
  • Mean Change From Baseline to Week 4 in Personal and Social Performance Scale (PSP) Scores(Baseline and Week 4)
  • Mean Change From Baseline to Week 12 in Personal and Social Performance Scale (PSP) Scores(Baseline and Week 12)
  • Mean Change From Baseline to Week 24 in Personal and Social Performance Scale (PSP) Scores(Baseline and Week 24)
  • Change From Baseline to Week 12 in Time Spent Awake at Night(Baseline and Week 12)
  • Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test(Baseline and Endpoint (Week 24 or last observation))
  • Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test(Baseline and Week 12)
  • Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Verbal Memory Test(Baseline and Week 24)
  • Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test (SDCT)(Baseline and Endpoint (Week 24 or last observation))
  • Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test(Baseline and Week 12)
  • Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - Symbol-digit Coding Test(Baseline and Week 24)
  • Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - Shifting Attention Test(Baseline and Endpoint (Week 24 or last observation))
  • Change From Baseline to Week 24 in Time Spent Awake at Night(Baseline and Week 24)
  • Mean Change From Baseline to Endpoint in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT](Baseline and Endpoint (Week 24 or last observation))
  • Mean Change From Baseline to Week 12 in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT](Baseline and Week 12)
  • Mean Change From Baseline to Week 24 in CNSVitalSigns Cognitive Battery Scores - 4-part Continuous Performance Test [CPT](Baseline and Week 24)
  • Changes From Baseline to Endpoint in the Abnormal Involuntary Movement Scale (AIMS) Total Scores(Baseline and Endpoint (Week 24 or last observation))
  • Changes From Baseline to Week 1 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores(Baseline and Week 1)
  • Changes From Baseline to Week 2 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores(Baseline and Week 2)
  • Changes From Baseline to Week 4 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores(Baseline and Week 4)
  • Changes From Baseline to Week 8 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores(Baseline and Week 8)
  • Changes From Baseline to Week 12 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores(Baseline and Week 12)
  • Changes From Baseline to Week 16 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores(Baseline and Week 16)
  • Changes From Baseline to Week 20 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores(Baseline and Week 20)
  • Changes From Baseline to Week 24 in the Abnormal Involuntary Movement Scale (AIMS) Total Scores(Baseline and Week 24)
  • Changes From Baseline to Endpoint in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score(Baseline and Endpoint (Week 24 or last observation))
  • Changes From Baseline to Week 1 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score(Baseline and Week 1)
  • Changes From Baseline to Week 2 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score(Baseline and Week 2)
  • Changes From Baseline to Week 4 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score(Baseline and Week 4)
  • Changes From Baseline to Week 8 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score(Baseline and Week 8)
  • Changes From Baseline to Week 12 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score(Baseline and Week 12)
  • Changes From Baseline to Week 16 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score(Baseline and Week 16)
  • Changes From Baseline to Week 20 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score(Baseline and Week 20)
  • Changes From Baseline to Week 24 in the Simpson-Angus Extrapyramidal Symptoms (EPS) Scale Total Score(Baseline and Week 24)
  • Change From Baseline to Endpoint in the Barnes Akathisia Rating Scale (BARS) Total Score(Baseline and Endpoint (Week 24 or last observation))
  • Change From Baseline to Week 1 in the Barnes Akathisia Rating Scale (BARS) Total Score(Baseline and Week 1)
  • Change From Baseline to Week 2 in the Barnes Akathisia Rating Scale (BARS) Total Score(Baseline and Week 2)
  • Change From Baseline to Week 4 in the Barnes Akathisia Rating Scale (BARS) Total Score(Baseline and Week 4)
  • Change From Baseline to Week 8 in the Barnes Akathisia Rating Scale (BARS) Total Score(Baseline and Week 8)
  • Change From Baseline to Week 12 in the Barnes Akathisia Rating Scale (BARS) Total Score(Baseline and Week 12)
  • Change From Baseline to Week 16 in the Barnes Akathisia Rating Scale (BARS) Total Score(Baseline and Week 16)
  • Change From Baseline to Week 20 in the Barnes Akathisia Rating Scale (BARS) Total Score(Baseline and Week 20)
  • Change From Baseline to Week 24 in the Barnes Akathisia Rating Scale (BARS) Total Score(Baseline and Week 24)
  • Change From Baseline to Endpoint in the Calgary Depression Scale for Schizophrenia (CDSS) Score(Baseline and Endpoint (Week 24 or last observation))
  • Change From Baseline to Week 1 in the Calgary Depression Scale for Schizophrenia (CDSS) Score(Baseline and Week 1)
  • Change From Baseline to Week 2 in the Calgary Depression Scale for Schizophrenia (CDSS) Score(Baseline and Week 2)
  • Change From Baseline to Week 4 in the Calgary Depression Scale for Schizophrenia (CDSS) Score(Baseline and Week 4)
  • Change From Baseline to Week 8 in the Calgary Depression Scale for Schizophrenia (CDSS) Score(Baseline and Week 8)
  • Change From Baseline to Week 12 in the Calgary Depression Scale for Schizophrenia (CDSS) Score(Baseline and Week 12)
  • Change From Baseline to Week 16 in the Calgary Depression Scale for Schizophrenia (CDSS) Score(Baseline and Week 16)
  • Change From Baseline to Week 20 in the Calgary Depression Scale for Schizophrenia (CDSS) Score(Baseline and Week 20)
  • Change From Baseline to Week 24 in the Calgary Depression Scale for Schizophrenia (CDSS) Score(Baseline and Week 24)
  • Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Endpoint(Endpoint (Week 24 or last observation))
  • Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 8(Week 8)
  • Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 16(Week 16)
  • Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Behavior at Week 24(Week 24)
  • Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Endpoint(Endpoint (Week 24 or last observation))
  • Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 8(Week 8)
  • Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 16(Week 16)
  • Columbia Suicide-Severity Rating Scale (C-SSRS) Scores - Percentage of Participants With Suicidal Ideations at Week 24(Week 24)
  • Change From Baseline to Endpoint in Sleep Latency(Baseline and Endpoint (Week 24 or last observation))
  • Change From Baseline to Week 12 in Sleep Latency(Baseline and Week 12)
  • Change From Baseline to Week 24 in Sleep Latency(Baseline and Week 24)
  • Change From Baseline to Endpoint in Number of Nighttime Awakenings(Baseline and Endpoint (Week 24 or last observation))
  • Change From Baseline to Week 12 in Number of Nighttime Awakenings(Baseline and Week 12)
  • Change From Baseline to Week 24 in Number of Nighttime Awakenings(Baseline and Week 24)
  • Change From Baseline to Endpoint in Time Spent Awake at Night(Baseline and Endpoint (Week 24 or last observation))
  • Change From Baseline to Endpoint in Time Spent Asleep at Night(Baseline and Endpoint (Week 24 or last observation))
  • Change From Baseline to Week 12 in Time Spent Asleep at Night(Baseline and Week 12)
  • Change From Baseline to Week 24 in Time Spent Asleep at Night(Baseline and Week 24)
  • Change From Baseline to Endpoint in Sleep Quality Rating(Baseline and Endpoint (Week 24 or last observation))
  • Change From Baseline to Week 12 in Sleep Quality Rating(Baseline and Week 12)
  • Change From Baseline to Week 24 in Sleep Quality Rating(Baseline and Week 24)

研究者

发起方
Cephalon
申办方类型
Industry
责任方
Sponsor

研究点 (39)

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