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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
OLANZAPINE ARM
placebo administered for 8 weeks
Research Ethics Committee (CEP)
São Paulo, São Paulo, Brazil
Evaluate the efficacy of olanzapine in reducing tinnitus symptoms in a randomized placebo-controlled crossover trial
• Tinnitus Handicap Inventory (THI): A 25-item questionnaire measuring tinnitus-related distress. Scores range from 0 to 100, with higher scores indicating greater handicap.
Time frame: From enrollment to the end of treatment at 12 weeks
Assess the clinical efficacy of olanzapine (5 mg/day) in reducing tinnitus symptoms, using a randomized, double-blind, placebo-controlled crossover design
• Visual Analog Scales (VAS): Patients rated tinnitus loudness and distress on 10-point scales (0 = none; 10 = extreme).
Time frame: From enrollment to the end of treatment at 12 weeks
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