Treatment of Tinnitus With Olanzapine: A Randomized Crossover Versus Placebo Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Evaluate the efficacy of olanzapine in reducing tinnitus symptoms in a randomized placebo-controlled crossover trial
研究概览
简要总结
This research aims to evaluate the effects of the drug olanzapine on the discomfort caused by tinnitus according to each patient's personality traits. Olanzapine is a drug used as an antipsychotic whose mechanism of action makes it potentially useful for the treatment of tinnitus.
详细描述
Patients will be evaluated through a standard history and otorhinolaryngological examination. Questionnaires will be used to assess tinnitus (Tinnitus Handicap Inventory) and personality (Neo Pi-R), and audiological examinations will be performed (pure-tone and vocal audiometry and immittance testing). All procedures aim to understand the impact of the disease on the patient's life, and audiological examinations aim to analyze the patient's hearing. To perform the procedures and examinations and monitor the treatment schedule, the patient will be required to attend the outpatient clinic monthly. The procedures and examinations do not pose any risk or physical discomfort to the interviewee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
To evaluate the efficacy of olanzapine in reducing tinnitus symptoms in a randomized placebo-controlled crossover trial
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjective, non-pulsatile tinnitus of at least 6 months' duration
- •Stable tinnitus symptoms over the past 3 months
- •Willingness to participate and provide informed consent
- •Age between 18 and 70 years
排除标准
- •Active psychiatric disorders requiring pharmacological treatment
- •History of psychotic illness or bipolar disorder
- •Current use of antipsychotics, antidepressants, or anticonvulsants
- •Severe hearing loss (threshold ≥ 80 dB in both ears)
- •Substance use disorders
- •Pregnancy or breastfeeding
- •Known hypersensitivity to olanzapine
- •Significant medical conditions (e.g., uncontrolled diabetes, hepatic impairment)
研究组 & 干预措施
PLACEBO ARM
placebo administered for 8 weeks
干预措施: Placebo Drug (Drug)
OLANZAPINE ARM
olanzapine 5 mg/day administered for 8 weeks
干预措施: Olanzapine 5 Mg ORAL TABLET (Drug)
结局指标
主要结局
Evaluate the efficacy of olanzapine in reducing tinnitus symptoms in a randomized placebo-controlled crossover trial
时间窗: From enrollment to the end of treatment at 12 weeks
• Tinnitus Handicap Inventory (THI): A 25-item questionnaire measuring tinnitus-related distress. Scores range from 0 to 100, with higher scores indicating greater handicap.
次要结局
- Assess the clinical efficacy of olanzapine (5 mg/day) in reducing tinnitus symptoms, using a randomized, double-blind, placebo-controlled crossover design(From enrollment to the end of treatment at 12 weeks)
研究者
Jeanne Oiticica
MD PhD
University of Sao Paulo