临床试验/NCT00922272

NCT00922272已完成2 期

A Phase 2, Multicenter Study With Open-label & Randomized Double-blind Placebo-controlled Withdrawal Phases to Evaluate the Efficacy, Safety, & Tolerability of SPD489 in Adults With Schizophrenia & Predominant Negative Symptoms Who Are Clinically Stable & Taking Stable Doses of Atypical Antipsychotic Medication

Shire27 个研究点分布在 1 个国家目标入组 92 人开始时间: 2009年9月14日最近更新: 2021年6月9日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Shire
入组人数: 92
试验地点: 27
主要终点: Change From Double-blind Randomization Baseline in SANS-18 Total Score at Week 4 Double-blind Phase, Termination Observation Carried Forward (TOCF)

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

To explore the efficacy of SPD489, as adjunctive therapy to a stable dose of atypical antipsychotic medication, on negative symptoms in adult subjects with clinically stable schizophrenia and predominant negative symptoms, as measured by the Scale for the Assessment of Negative Symptoms (SANS).

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 55 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•Adults aged 18-55
•Clinically stable Schizophrenia and predominant negative symptoms
•Taking a stable dose of antipsychotic medication

排除标准

•Clinically notable positive symptoms defined by PANSS

研究组 & 干预措施

SPD489 (Lisdexamfetamine dimesylate)

Experimental

干预措施: SPD489 (lisdexamfetamine dimesylate) (Drug)

Placebo

Placebo Comparator

Placebo

干预措施: Placebo matching SPD489 (lisdexamfetamine dimesylate) (Drug)

结局指标

主要结局

Change From Double-blind Randomization Baseline in SANS-18 Total Score at Week 4 Double-blind Phase, Termination Observation Carried Forward (TOCF)

时间窗: Double-blind Randomization Baseline and Week 4 Double-blind Phase

The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.

Change From Open-label Baseline in Modified Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Week 10 Open-label Phase, Last Observation Carried Forward (LOCF)

时间窗: Open-label Baseline and Week 10 Open-label Phase

次要结局

Change From Double-blind Randomization Baseline in SANS Global Scores at Week 4 Double-blind Phase(Double-blind Randomization Baseline and Week 4 Double-blind Phase)
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Open-label Baseline(Open-label Baseline)
Percent of Participants With CGI-S at Double-blind Randomization Baseline(Double-blind Randomization Baseline)
Change From Open-label Baseline in Behavioral Rating Inventory of Executive Function - Adult Version (BRIEF-A) T-scores at Week 10 Open-label Phase(Open-label Baseline and Week 10 Open-label Phase)
Change From Double-blind Randomization Baseline in PANSS Scores at Week 4 Double-blind Phase, TOCF(Double-blind Randomization Baseline and Week 4 Double-blind Phase)
Percent of Participants With CGI-S at Week 10 Open-label Phase(Week 10 Open-label Phase)
Percent of Participants In Double-blind Phase Who Maintained SANS-18 Response at Week 4 Double-blind Phase(Week 4 Double-blind Phase)
Change From Open-label Baseline in the Brief Assessment of Cognition in Schizophrenia (BACS) Total Score at Week 10 Open-label Phase(Open-label Baseline and week 10 Open-label Phase)
Change From Open-label Baseline in Letter-Number Span Test (LNS) Total Score at Week 10 Open-label Phase(Open-label Baseline and week 10 Open-label Phase)
Change From Double-blind Randomization Baseline in LNS Total Score at Week 4 Double-blind Phase(Double-blind Randomization Baseline and Week 4)
Change From Open-label Baseline in SANS Global Scores at Week 10 Open-label Phase(Open-label Baseline and Week 10 Open-label Phase)
Change From Open-label Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at Week 10 Open-label Phase, LOCF(Open-label Baseline and Week 10 Open-label Phase)
Percent of Participants With Improvement on CGI-C at Week 4 Double-blind Phase(Double-blind Phase Week 4)
Change From Double-blind Randomization Baseline in UPSA-B Scores at Week 4 Double-blind Phase(Double-blind Randomization Baseline and Week 4 Double-blind Phase)
Change From Open-label Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 10 Open-label Phase(Open-label Baseline and Week 10 Open-label Phase)
Percent of Participants In Open-label Phase Who Were SANS-18 Responders at Week 10 Open-label Phase(Week 10 Open-label Phase)
Percent of Participants With CGI-S at Week 4 Double-blind Phase(Week 4 Double-blind Phase)
Change From Double-blind Randomization Baseline in BACS Total Score at Week 4 Double-blind Phase(Double-blind Randomization Baseline and Week 4)
Change From Open-label Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) Total Score at Week 10 Open-label Phase(Open-label Baseline and Week 10)
Change From Open-label Baseline in SAS Total Score at Week 4 of Double-blind Phase(Open-label Baseline and Week 4 Double-blind Phase)
Change From Open-label Baseline in BAS Scores at Week 4 of Double-blind Phase(Open-label Baseline and Week 4 Double-blind Phase)
Change From Open-label Baseline in PSQI Total Global Score at Week 4 of Double-blind Phase(Open-label Baseline and Week 4 Double-blind Phase)
Percent of Participants With Improvement on Clinical Global Impression - Change (CGI-C) at Week 10 Open-label Phase(Open-label Phase Week 10)
Change From Double-blind Randomization Baseline in HVLT-R Total Scores at Week 4 Double-blind Phase(Double-blind Randomization Baseline and week 4 Double-blind Phase)
Change From Open-label Baseline in Simpson Angus Scale (SAS) Total Score at Week 10 Open-label Phase(Open-label Baseline and Week 10 Open-label Phase)
Change From Open-label Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Global Score at Week 10 Open-label Phase(Open-label Baseline and Week 10 Open-label Phase)
Change From Open-label Baseline in University of California Performance-Based Skills Assessment, Brief Version (UPSA-B) Scores at Week 10 Open-label Phase, LOCF(Open-label Baseline and week 10 Open-label Phase)
Change From Double-blind Randomization Baseline in BRIEF-A T-Scores at Week 4 Double-blind Phase(Double-blind Randomization Baseline and Week 4 Double-blind Phase)
Change From Open-label Baseline in CDSS at Week 4 of Double-blind Phase(Open-label Baseline and Week 4 of Double-blind Phase)
Change From Open-label Baseline in Barnes Akathisia Scale (BAS) Scores at Week 10 Open-label Phase(Open-label Baseline and week 10 Open-label Phase)
Change From Double-blind Randomization Baseline in ACSA Total Score at Week 4 Double-blind Phase(Double-blind Randomization Baseline and Week 4 Double-blind Phase)
Change From Open-label Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at Week 10 Open-label Phase(Open-label Baseline and Week 10 Open-label Phase)

研究者

发起方

Shire

申办方类型

Industry

责任方

Sponsor

研究点 (27)

Loading locations...

相似试验

已完成

2 期

Exploratory Study of SPD489 in Adults With Major Depressive Disorder (MDD) as Augmentation Therapy to an AntidepressantMajor Depressive Disorder

NCT00905424Shire246

已完成

3 期

Safety of SPD417 Combined With Other Psychotropic Medications in the Treatment of Bipolar I DisorderBipolar Disorder

NCT00150605Validus Pharmaceuticals50

已完成

2 期

A Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Adults With SchizophreniaSchizophrenia

NCT02969382Otsuka Pharmaceutical Development & Commercialization, Inc.245

撤回

3 期

Safety and Efficacy of SPD489 in Adolescent Subjects Aged 13-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)ADHD

NCT01274221Shire

已完成

2 期

A Study of LY2140023 in Schizophrenia Patients With Prominent Negative SymptomsSchizophrenia

NCT01052103Denovo Biopharma LLC167