Efficacy of Pimozide Augmentation for Clozapine Partial Response
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Brief Psychiatric Rating Scale (BPRS) Total Score
研究概览
简要总结
This is a 12 week outpatient study for patients with schizophrenia who are on Clozapine, but continue to experience symptoms. The purpose of this project is to find out if small doses of pimozide (an antipsychotic medication, taken by mouth) will be helpful in reducing symptoms (such as hearing voices, having trouble in organizing your thoughts, lack of interest in life events and social activities), compared to placebo (an inactive substance, "sugar pill"), when added to clozapine in patients with schizophrenia.
The participant will be asked to come in once a week to meet with the research staff and study doctor. The participant will continue to see your regular clinician during this study for all normal appointments. The participant will remain on your current medications throughout the study. During the study you will be randomly selected to be put on a small dose of Pimozide or placebo.
详细描述
If you choose to participate, you will first have screening tests to find out if you are eligible. The study physician will do a number of tests including a physical examination, a routine medical history, lab tests for blood and urine, and EKG (to monitor your heart) and interviews about your physical and mental health.
At each visit you will complete an EKG (to monitor your heart), vital signs, and discuss how you are feeling with the research staff and doctor. Once a month, we will also conduct a slightly longer interview with you about your symptoms and draw one tube of blood to check your Clozapine level. At the beginning and end of the study, you will do some pencil and paper games called "Neurocognitive tests".
If you are interested in participating in this study, we will go over it in greater detail with you, including the possible benefits and risks associated with participating. We will make sure you understand the study before you begin. This study is completely voluntary, which means that you can choose to stop participating in the study at any time.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia or schizoaffective disorder.
- •A minimum Brief Psychiatric Rating Scale (BPRS) score of 35 and a BPRS psychotic symptom cluster score of at least
- •Currently taking clozapine with a blood level between 350-1000 ng/ml and on a stable dose of clozapine for the past 2 weeks.
- •Able to give informed consent.
排除标准
- •A history of significant medical/neurological disease such as thyroid, renal, hepatic abnormality, seizure disorder.
- •History of Neuroleptic Malignant Syndrome.
- •Current substance abuse determined by urine toxicology.
- •Cardiac arrhythmia, sinus bradycardia (heart rate less than 60/min), sinus tachycardia (heart rate greater than 110/min), supraventricular tachycardia, ventricular tachycardia, Wolff-Parkinson-White Syndrome, first, second, third degree atrioventricular (AV) block, atrial fibrillation, atrial flutter and junctional complexes. in baseline electrocardiogram (EKG). Study doctors will examine the EKGs and consult with an internist/cardiologist as needed.
- •on EKG: QTc > 450 ms.
- •Current use of macrolide antibiotics (e.g., erythromycin, clarithromycin), azole antifungal agents (e.g., ketoconazole, itraconazole), protease inhibitors (e.g., ritonavir, indinavir), nefazodone, and other medications that are associated with prolonged QTc.
- •Current use of antipsychotics other than clozapine.
- •Current use of sertraline.
- •IQ level below
- •At high risk for suicidal/homicidal behavior.
- •Pregnancy, lack of birth control for females of childbearing age (female patients must report use of effective method for birth control such as birth control pills, condoms, barrier methods, abstinence or have written statement from their doctors that they are medically sterile).
- •Non-English speaking.
研究组 & 干预措施
2
active pimozide
干预措施: Pimozide (Drug)
1
placebo pimozide
干预措施: placebo (Drug)
结局指标
主要结局
Brief Psychiatric Rating Scale (BPRS) Total Score
时间窗: Endpoint (12 weeks)
The Brief Psychiatric Rating Scale (BPRS) is an 18-item instrument. The items are anchored on a 7-point scale (higher rating: greater severity). Total scores range from 18 to 126 (higher score: greater severity). The instrument covers areas including: somatic concerns, anxiety, emotional withdrawal, conceptual disorganization, guilt feelings, tension, mannerisms and posturing, grandiosity, depressive mood, hostility, suspiciousness, hallucinatory behavior, motor retardation, uncooperativeness, unusual thought content, blunted affect, excitement and disorientation.
Scale for the Assessment of Negative Symptoms (SANS)
时间窗: Endpoint (12 weeks)
The Scale for the Assessment of Negative Symptoms (SANS) is a rating scale to measure negative symptoms in schizophrenia. The scale has 25 items (20 individual and 5 global) rated on scale of 0-5 (higher rating: greater severity). SANS is split into 5 domains, and within each domain separate symptoms are rated from 0 (absent) to 5 (severe). Domains include: Affective Flattening or Blunting, Alogia, Avolition - Apathy, Anhedonia - Asociality, Attention. The total range of the SANS is from 0 to 120.
次要结局
- Verbal Learning and Memory: List B(Endpoint (12 weeks))
- Trail Making Test: Trail A(Endpoint (12 weeks))
- Trail Making Test: Trail B(Endpoint (12 weeks))
- Verbal Fluency(Endpoint (12 weeks))
- Processing Speed(Endpoint (12 weeks))
- QTc(Endpoint (12 weeks))
- Verbal Learning and Memory: List A(Endpoint (12 weeks))
- CGI Severity of Illness Scale (CGI-S)(Endpoint (12 weeks))
- CGI Improvement Scale (CGI-I)(Endpoint (12 weeks))