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OpenTrials
Completed

NCT Number: NCT07190482

Treatment of Tinnitus With Olanzapine

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.

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Key information

Conditions

Tinnitus Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Tinnitus, Subjective

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Ethics Committee (CEP)

São Paulo, 05403000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Olanzapine 5 Mg ORAL TABLET

Drug

OLANZAPINE ARM

Other names: Zyprexa, OLZ

Placebo drug

Drug

placebo administered for 8 weeks

Other names: Sham treatment

Primary outcomes

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

    Time frame: 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 outcomes

  1. Assess the clinical efficacy of olanzapine (5 mg/day) in reducing tinnitus symptoms, using a randomized, double-blind, placebo-controlled crossover design

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Acronym: OLANZAP_TIN

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Sep 24, 2025
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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