Ziprasidone Switching in Response to Adherence and Psychotropic-Related Weight Gain Concerns Among Patients With Bipolar Disorder (Zip Ad) (Zip Ad)
2014年12月8日 更新者：Martha Sajatovic、University Hospitals Cleveland Medical Center
Ziprasidone Switching in Response to Adherence and Psychotropic-Related Weight Gain Concerns Among Patients With Bipolar Disorder
Psychotropic-related weight gain is a common concern among patients with bipolar disorder (BD).
This concern affects an individual's satisfaction with treatment and may lead to reduced adherence and illness relapse.
Patient-focused care is attentive to patient concerns while at the same time utilizing evidence-based treatments.
Ziprasidone is currently FDA approved for the maintenance treatment of BD.
Ziprasidone may be associated with less weight gain compared to some alternative BD maintenance treatments.
The proposed project will evaluate how switching to ziprasidone may affect patient adherence, drug attitudes, satisfaction with care and clinical outcomes (psychiatric symptoms, functional status, weight) among BD patients concerned with weight gain.
研究概览
研究类型
介入性
注册 (实际的)
30
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Ohio
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Cleveland、Ohio、美国、44106
- University Hospitals Case Medical Center
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Diagnosis of Type I or II BD for at least 6 months (confirmed with MINI)
- On maintenance evidence-based treatment for BD (lithium, antipsychotic, anticonvulsant)
- Have weight gain concerns that individual believes are related to BD medication treatment
- Sub-optimal adherence as measured by the Tablet Routines Questionnaire (TRQ) and which the patient feels is related to weight gain concerns. TRQ threshold will be defined as missing an average of 20% or more of all prescribed BD treatment in the last week or month or missing 20% or more of the "offending agent" in the last week or last month. This is consistent with methodologies in PIs previous BD adherence studies
Exclusion Criteria:
- Known resistance or intolerance to ziprasidone
- Medical contraindication to ziprasidone
- Individuals on ziprasidone immediately prior to study enrollment
- Prior or current treatment with clozapine
- Diagnosis of eating disorder
- Individuals whose sub-optimal adherence is related to inability to pay for BD medication treatment or inability to arrange transportation to BD treatment clinical visits
- Concurrent medical condition or psychiatric illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial
- Current substance dependence
- High risk of harm to self or others
- Female who is currently pregnant or breastfeeding
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Medication Adherence Bipolar Disorder
There was only one group in this study.
All participants received the study drug Ziprasidone.
|
Patients will identify which psychotropic they currently receive that causes the most weight-gain concern.
For individuals on multiple drugs, one drug must be identified as the "offending agent".
Study psychiatrist will switch the "offending agent" to ziprasidone.
Participants will be switched to ziprasidone per package insert.
Patients will be maintained on ziprasidone for 12 weeks (active part of study).
After the active part of the study they will return to the care of their normal clinical provider who will determine whether they will continue on ziprasidone.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Treatment Non-adherence Percentage as Measured by the Tablet Routines Questionnaire (TRQ)
大体时间：Week 16
|
Scale Range: 0-100%.
The score represents percentage of time that required medication doses were missed.
Higher scores indicate lower medication adherence.
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Week 16
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Treatment Adherence Score as Measured by the Morisky Rating Scale
大体时间：Week 16
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Four item inventory taken by participant with Scale Range: 0-4.
Lower scores indicate improved outcomes.
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Week 16
|
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Attitude Toward Medication Score as Measured by the Drug Attitude Inventory
大体时间：Week 16
|
Ten item inventory taken by the participant with a Scale Range: 0-10.
Higher scores indicate improved outcomes.
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Week 16
|
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Global Psychopathology Score as Measured by Clinical Global Impressions
大体时间：Week 16
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Global psychopathology will be measured with the Clinical Global Impressions (CGI) (Guy 1976) a widely used scale which evaluates illness severity on a 1 to 7 point continuum.
Severity of illness ratings on the CGI have reported reliability scores ranging from 0.41-0.66
(Guy 1976).
Lower scores indicate improved outcomes.
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Week 16
|
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Social and Occupational Functioning Scale
大体时间：Week 16
|
Life and Work Functional status will be evaluated using the Social and Occupational Functioning Scale (SOFAS), which is derived from the GAF (Global Assessment of Functioning).
The GAF is a 100-point single-item scale which measures global functioning of psychiatric patients and is widely utilized in clinical studies involving Seriously Mentally Ill patients (Jones 1995).
The reliability of the GAF ranges from 0.62-0.82.
Higher scores indicate improved outcomes.
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Week 16
|
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Montgomery Asberg Depression Rating Scale
大体时间：Week 16
|
Scale Range: 0-60.
Lower scores indicate better outcomes.
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Week 16
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Young Mania Rating Scale
大体时间：Week 16
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Scale Range: 0-60.
Lower scores indicate better outcomes.
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Week 16
|
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Body Weight
大体时间：Week 16
|
Week 16
|
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Quality of Life Score as Measured by 12-item Short Form Health Survey
大体时间：Week 16
|
Scale Range: 1-99th percentile score.
Higher scores indicate better outcomes.
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Week 16
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Martha Sajatovic, M.D.、Case Western Reserve University School of Medicine
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年1月1日
初级完成 (实际的)
2012年8月1日
研究完成 (实际的)
2012年8月1日
研究注册日期
首次提交
2011年2月10日
首先提交符合 QC 标准的
2011年2月10日
首次发布 (估计)
2011年2月11日
研究记录更新
最后更新发布 (估计)
2014年12月30日
上次提交的符合 QC 标准的更新
2014年12月8日
最后验证
2014年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.