Completed

OLANZAP_TINOlanzapine for Tinnitus Relief

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What is being tested

Olanzapine 5 Mg ORAL TABLET

+ Placebo Drug

Drug
Who is being recruted

Ear Diseases+6

+ Hearing Disorders

+ Nervous System Diseases

From 18 to 70 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 1
Interventional
Study Start: October 2023
See protocol details

Summary

Principal SponsorUniversity of Sao Paulo
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2023

Actual date on which the first participant was enrolled.

This study is exploring the use of a medication called Olanzapine to treat tinnitus, which is a condition where people hear ringing or noise in their ears without an external source. The study is aimed at individuals who experience tinnitus to see if Olanzapine can help reduce the symptoms. Understanding the impact of tinnitus on a person's life is important because it can affect daily activities and quality of life. This research could potentially lead to a new treatment option for those suffering from this challenging condition. Participants in the study will visit a clinic once a month where they will undergo various assessments. These include a detailed medical history check, an ear, nose, and throat examination, as well as hearing tests to evaluate their hearing abilities. They will also complete questionnaires to assess the severity of their tinnitus and aspects of their personality. Olanzapine or a placebo will be administered, and the effects will be monitored over time. The study procedures are designed to be safe and should not cause any discomfort to those involved.

Official TitleTreatment of Tinnitus With Olanzapine: A Randomized Crossover Versus Placebo Study
NCT07190482
Principal SponsorUniversity of Sao Paulo
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Ear DiseasesHearing DisordersNervous System DiseasesNeurologic ManifestationsOtorhinolaryngologic DiseasesSensation DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsTinnitus

Criteria

4 inclusion criteria required to participate
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
8 exclusion criteria prevent from participating
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)
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
olanzapine 5 mg/day administered for 8 weeks

Group II

Placebo
placebo administered for 8 weeks

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Research Ethics Committee (CEP)

São Paulo, BrazilOpen Research Ethics Committee (CEP) in Google Maps
CompletedOne Study Center