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临床试验/NCT01962402
NCT01962402Unknown4 期

Lorcaserin for Weight Loss Management in Patients on Antipsychotics: A Pilot Study

Southern California Institute for Research and Education1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
15
试验地点
1
主要终点
Weight loss

研究概览

简要总结

The purpose of this study is to determine whether lorcaserin is effective for weight reduction in patients with weight gain as a result of antipsychotic medications.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Lorcaserin with intensive diet counseling

Experimental

Patients will be taking lorcaserin 10mg tablet by mouth twice daily. In addition, patients will be provided with intensive dietary counseling to promote weight loss.

干预措施: lorcaserin (Drug)

Lorcaserin with intensive diet counseling

Experimental

Patients will be taking lorcaserin 10mg tablet by mouth twice daily. In addition, patients will be provided with intensive dietary counseling to promote weight loss.

干预措施: Intensive dietary counseling (Behavioral)

结局指标

主要结局

Weight loss

时间窗: initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study

The primary objective of this study is to evaluate the effectiveness of lorcaserin for weight loss management in patients on an antipsychotic agent. Will monitor the weight of the patient for evaluation.

次要结局

  • Evaluation of cravings(initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study)
  • Monitoring of mood(At initial visit, then at week 4 and week 12 of the study)
  • Evaluation of systolic blood pressure(initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study)
  • Evaluation of diastolic blood pressure(initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study)
  • Evaluation of pulse(initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study)
  • Evaluation of body-mass index (BMI)(initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study)
  • Evaluation of waist circumference(initial visit with provider, then at weeks 1, 2, 4, 8, 12, and 16 of the study)
  • Evaluation of glucose control(At initial visit and at week 12 of the study)
  • Evaluation of cholesterol control(At initial visit and at week 12 of the study)
  • Evaluation of electrolytes(At initial visit and at week 12 of the study)
  • Evaluation of liver(At initial visit and at week 12 of the study)
  • Evaluation of blood count(At initial visit and at week 12 of the study)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Charles Nguyen

Psychiatrist

Southern California Institute for Research and Education

研究点 (1)

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