Adjunct Aripiprazole for Symptomatic Hyperprolactinemia in Female Schizophrenia

阿立哌唑辅助治疗女性精神分裂症症状性高催乳素血症

基本信息

批准号：
8310920
负责人：
DEANNA L KELLY
金额：
$ 30.7万
依托单位：
UNIVERSITY OF MARYLAND BALTIMORE
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-08-02 至 2015-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8310920
关键词：
Adverse effects Agonist Amantadine Amenorrhea Antipsychotic Agents Anxiety Area Biological Assay Biological Markers Bone Density Bromocriptine Consensus Cost Analysis Costs and Benefits Data Distress Dopamine Dopamine Agonists Dopamine Antagonists Dose Double-Blind Method Estrogens Evidence based treatment Female Funding Gender Gonadal Steroid Hormones Gynecomastia Hormonal Hyperprolactinemia Individual Intervention Knowledge Measures Mediator of activation protein Menstruation Mental Health Mental disorders Mission Modeling National Institute of Mental Health New Agents Oligomenorrhea Outcome Patients Perceived quality of life Personal Satisfaction Pharmaceutical Preparations Placebos Population Progesterone Prolactin Quality of life Randomized Recovery Regimen Relative (related person)Reporting Research Research Design Resolution Risperidone Schizophrenia Sedation procedure Sex Characteristics Sex Functioning Sexual Dysfunction Symptoms Testing Time Treatment Effectiveness Weight Gain Woman Work aripiprazole bone health bone turnover control trial cost depressive symptoms design evidence based guidelines experience improved innovation medication compliance research study response sex

项目摘要

DESCRIPTION (provided by applicant): Risperidone is available generically and one of the most widely used antipsychotic medications; but is associated with elevated prolactin. This elevation is particularly pronounced in women and most recent studies show that the vast majority of women have elevated prolactin levels with approximately 50% also having the corresponding side effects of amenorrhea, oligomenorrhea or galactorrhea. Elevated prolactin may be associated with sexual dysfunction, decreased quality of life, medication nonadherence and decreases in bone mineral density over time. Lowering the dose or switching medications due to this side effect in stabilized patients is not a practical option in most cases. There is little evidence to guide treatment in this important area however dopamine agonists such as bromocriptine or amantadine may exacerbate symptoms, have lacking efficacy data and are associated with side effects. We have sizeable pilot data to suggest that a low dose of aripiprazole (10 mg/day), a dopamine partial agonist, added to Risperidone can improve symptomatic prolactin side effects. We will complete a double blind randomized 16-week control trial examining adjunct aripiprazole (10 mg/day with increase to 15 mg/day at 8 weeks if no response) vs. placebo in 70 women with symptomatic hyperprolactinemia and hypothesize it will be effective in the resolution of amenorrhea, oligomenorrhea and galactorrhea. We also hypothesize that aripiprazole will significantly improve quality of life, personal well-being and sexual function. And, we will examine improvements in positive, negative and depressive symptoms, sex hormone levels and measures of bone turnover. The significance and innovation of this application is high as this is a significant complaint and concern of women and very little evidence is available to guide treatment in women who are stabilized and doing well on antipsychotic treatments but develop these significant side effects. If funded, this important treatment research study of adjunct aripiprazole treatment will provide invaluable data and treatment options for thousands of women who suffer from schizophrenia and will help move the field towards better tailoring and personalizing antipsychotic treatment, particularly for women who suffer from these problems.

描述（由申请人提供）：利培酮通常可以使用，也是使用最广泛的抗精神病药物之一；但与催乳素升高有关。这种升高在女性中特别明显，最近的研究表明，绝大多数妇女的催乳素水平升高，大约50％的妇女也具有闭经，寡瘤或半乳酸的相应副作用。催乳素升高可能与性功能障碍，生活质量降低，药物不遵守和骨矿物质密度降低有关。在大多数情况下，由于稳定患者的副作用而降低剂量或切换药物并不是实际选择。几乎没有证据可以指导在这一重要领域的治疗，但是多巴胺激动剂（例如溴o不平或阿甘达丁）可能会加剧症状，缺乏疗效数据，并且与副作用有关。我们有大量的试点数据，以表明低剂量的阿piprazole（10毫克/天）是多巴胺部分激动剂，添加到利培酮中可以改善症状性催乳素副作用。我们将完成一项双盲随机16周对照试验，检查辅助阿ipiprazole（如果没有反应，在8周时增加至15 mg/day/天的15毫克/天）与70名有症状性高骨质症的女性的安慰剂，并假设它将有效闭经，少突术和甲乳转化的分辨率。我们还假设阿立哌唑将显着改善生活质量，个人福祉和性功能。而且，我们将检查正面，阴性和抑郁症状，性激素水平以及骨转换量度的改善。该应用的重要性和创新很高，因为这是妇女的重大抱怨和关注，几乎没有证据可以指导稳定并在抗精神病药上做得很好的女性治疗，但会产生这些重大的副作用。如果获得资助，这项对辅助阿立哌唑治疗的重要治疗研究将为成千上万患有精神分裂症的妇女提供宝贵的数据和治疗选择，并将有助于使该领域改善抗精神病药物治疗，尤其是针对患有这些问题的妇女。