Evaluating the Effects of Adjunctive Aripiprazole on Weight and Metabolic Outcomes in Females Receiving Atypical Antipsychotics: a Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 600
- 主要终点
- Mean change in body weight in kilograms
研究概览
简要总结
Patients with psychiatric disorders, including depression, anxiety, and schizophrenia, often require antipsychotic medications for symptom management. However, metabolic changes, especially weight gain, are a common and challenging side effect of many antipsychotics. Aripiprazole, an atypical antipsychotic, has shown promise in mitigating this adverse effect when used in combination with other antipsychotic medications.
详细描述
This study aims to investigate the effectiveness of different combinations of aripiprazole with atypical antipsychotics in preventing or minimizing weight gain in patients with various psychiatric conditions. While weight gain affects both genders, females may be particularly vulnerable due to physiological differences and societal pressures related to body image.
Collectively, while individual studies have specific nuances, the general trend suggests that combining Aripiprazole with dietary modifications and potentially lifestyle changes shows promise in managing weight gain associated with antipsychotic medications in females.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors will be blinded.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females aged 18-65 years diagnosed with a mental health condition necessitating antipsychotic treatment.
- •Diagnosis of Schizophrenia or Schizoaffective Disorder
- •On stable doses of atypical antipsychotics, either Olanzapine, Clozapine, or Risperidone for at least 1 month
- •Willingness to comply with the study protocol.
排除标准
- •Pregnancy or lactation.
- •Severe medical conditions impacting weight or metabolism.
- •Previous intolerance or contraindications to Aripiprazole.
- •Non-compliant with prescribed medications
- •Mental Retardation
- •Participant with an eating disorder
- •Participants with serious suicidal thoughts, or who pose a serious risk of harm to self or to others.
- •Diagnosis of Hyper or Hypothyroidism; Evidence of thyroid dysfunction as evidenced by serum thyroid function tests (i.e Thyroid Stimulating Hormone and -Free Thyroxine (fT4) levels > 10 % above or below the limits of the normal range Use of any medication for weight loss within the past one month to the study entry
- •Clinically significant abnormalities in physical examinations, ECG or lab assessments
研究组 & 干预措施
Intervention group
The intervention group will be added 5 mg of aripiprazole as an adjunct with the usual antipsychotic treatment to the females on antipsychotic treatment
干预措施: Adjunctive Aripiprazole for improving Weight and Metabolic Outcomes in Females (Drug)
结局指标
主要结局
Mean change in body weight in kilograms
时间窗: 6-months from baseline
Mean change in body weight measured by digital weight machine
次要结局
- Body Mass Index (BMI)(6-months from baseline)
- Metabolic markers (fasting blood glucose; HbA1c; triglycerides; total, HDL and LDL cholesterol levels)(12 months from baseline)
- Change in waist circumference in cm(6-months from baseline)
研究者
Arshed Muhammad
PhD studentship
Universiti Putra Malaysia