Treatment of Tinnitus With Olanzapine

Not Applicable

Completed

• Conditions: Tinnitus; Tinnitus, Subjective
• Interventions: Drug: Olanzapine 5 Mg ORAL TABLET; Drug: Placebo Drug

• Registration Number: NCT07190482
• Lead Sponsor: University of Sao Paulo

Brief 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.

Study Timeline

• Study Start: 2023-10-01
• Primary Completion: 2024-12-20
• Study Completion: 2025-01-20
• Status Verified: 2025-09
• Study First Submitted: 2025-09-12
• Study First Submitted QC: 2025-09-19
• Last Update Submitted: 2025-09-19
• Study First Posted: 2025-09-24
• Last Update Posted: 2025-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OLANZAPINE ARM	Olanzapine 5 Mg ORAL TABLET	olanzapine 5 mg/day administered for 8 weeks
PLACEBO ARM	Placebo Drug	placebo administered for 8 weeks

Primary Outcome Measures

Name	Time	Method
Evaluate the efficacy of olanzapine in reducing tinnitus symptoms in a randomized placebo-controlled crossover trial	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.

Secondary Outcome Measures

Name	Time	Method
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	• Visual Analog Scales (VAS): Patients rated tinnitus loudness and distress on 10-point scales (0 = none; 10 = extreme).

Trial Locations

Locations (1)

Research Ethics Committee (CEP); 🇧🇷 São Paulo, São Paulo, Brazil