Zonegran for the Treatment of Weight Gain Associated With Psychotropic Medication Use: A Placebo-Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The primary objective of this study is to compare the efficacy of zonisamide (Zonegran; 100mg - 400mg/day) and placebo as an adjunctive agent on lowering weight in subjects who have a body mass index (BMI) of >25 and are on a psychotropic medication with
研究概览
简要总结
The primary objective of this study is to compare the efficacy of zonisamide (Zonegran; 100mg - 400mg/day) and placebo as an adjunctive agent on lowering weight in subjects who have a body mass index (BMI) of >25 and are on a psychotropic medication with a known side effect of weight gain.
详细描述
After the screening period, patients fulfilling entrance criteria will be randomized to 100mg of zonisamide or placebo in a 2:1 ratio respectively. Patients will be assessed at baseline and on Weeks 2, 4, 8, 12, and 16-post randomization for weight, side effects, and symptoms. Symptoms will be assessed by the Young Mania Rating Scale (YMRS), Brief Psychiatric Rating Scale (BPRS), Hamilton Depression Rating Scale (HAMD), Hamilton Rating Scale for Anxiety (HARS), and Self-report measures of general health and mental status at baseline, weeks 2, 4, 8, 12,and 16. At the conclusion of the study, patients will be tapered from the study medication and will return to their primary provider for continued treatment of their psychiatric condition.
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are men or women, between the ages of 19 and 65, inclusive
- •Have a diagnosis of any type of bipolar disorder or any type of psychotic disorder based on structured diagnostic interview (MINI).
- •Are currently outpatients or inpatients and taking a neuroleptic or mood stabilizer medication (listed below) for the past 6 months, and on a stable dose for the past 2 months.
- •Have a body mass index >
- •No substance use disorder in the past 2 months (except for nicotine or caffeine).
- •Agree to not become pregnant during the study and agree to use an adequate method of birth control during the study such as a barrier method, hormonal contraceptive, or surgical sterilization (females only). All women of childbearing potential must have a negative pregnancy test before beginning study medication.
- •Are able to swallow the capsules whole
- •Are willing and able to follow Investigator instructions and study procedures, and report adverse events
- •Not currently actively suicidal or homicidal.
- •No use of topiramate within the last 6 months.
- •No medical contraindication to the use of zonisamide.
- •List of medications for inclusion criterion #3:
- •All conventional neuroleptics. All atypical neuroleptics except aripiprazole or ziprasidone. All forms of valproate. All forms of lithium. All forms of carbamazepine.
排除标准
- •Clinically significant renal or hepatic disease.
- •History of acute intermittent porphyria, glucose-6phosphate dehydrogenase deficiency or hemolytic anemia.
- •Allergy to zonisamide or sulfonamides.
- •Have clinically unstable cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine, or other systemic disease
- •Have laboratory test results that, in the opinion of the Investigator, are clinically significant abnormalities
- •Require treatment with any medication (e.g., carbonic anhydrase inhibitors) that might interact adversely with, or obscure, the action of the study drug
- •Are pregnant or lactating (females only)
- •Have a history of nephrolithiasis
- •Refuse to give informed consent
- •Have previously enrolled in this study or previously been treated with zonisamide
研究组 & 干预措施
Zonegran
Zonegran
干预措施: Zonegran (Drug)
Placebo
Placebo pill
干预措施: Placebo (Drug)
结局指标
主要结局
The primary objective of this study is to compare the efficacy of zonisamide (Zonegran; 100mg - 400mg/day) and placebo as an adjunctive agent on lowering weight in subjects who have a body mass index (BMI) of >25 and are on a psychotropic medication with
次要结局
- NThe weight loss in patients treated with Zonisamide will be significantly greater than those treated with placebo.
研究者
Lori Davis, MD
ACOS R&D
Tuscaloosa Research & Education Advancement Corporation