Ziprasidone Switching in Response to Adherence and Psychotropic-Related Weight Gain Concerns Among Patients With Bipolar Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Treatment Non-adherence Percentage as Measured by the Tablet Routines Questionnaire (TRQ)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Medication Adherence Bipolar Disorder
There was only one group in this study. All participants received the study drug Ziprasidone.
干预措施: ziprasidone (Drug)
结局指标
主要结局
Treatment Non-adherence Percentage as Measured by the Tablet Routines Questionnaire (TRQ)
时间窗: Week 16
Scale Range: 0-100%. The score represents percentage of time that required medication doses were missed. Higher scores indicate lower medication adherence.
次要结局
- Global Psychopathology Score as Measured by Clinical Global Impressions(Week 16)
- Attitude Toward Medication Score as Measured by the Drug Attitude Inventory(Week 16)
- Montgomery Asberg Depression Rating Scale(Week 16)
- Young Mania Rating Scale(Week 16)
- Social and Occupational Functioning Scale(Week 16)
- Body Weight(Week 16)
- Quality of Life Score as Measured by 12-item Short Form Health Survey(Week 16)
- Treatment Adherence Score as Measured by the Morisky Rating Scale(Week 16)
研究者
Martha Sajatovic
Professor of Psychiatry
University Hospitals Cleveland Medical Center