NCT07190482

Treatment of Tinnitus With Olanzapine

Treatment of Tinnitus With Olanzapine: A Randomized Crossover Versus Placebo Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Tinnitus
• Tinnitus, Subjective

Interventions

Type	Name	Description
DRUG	Olanzapine 5 Mg ORAL TABLET	OLANZAPINE ARM
DRUG	Placebo Drug	placebo administered for 8 weeks

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-12-20
• Completion: 2025-01-20
• First posted: 2025-09-24
• Last updated: 2025-09-24

Locations

1 site across 1 country: Brazil