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Antipsychotic drug could quiet ringing ears

NCT ID NCT07190482

Symptom relief Sponsor: University of Sao Paulo Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 16, 2026 · Updated 3 times

Summary

This completed Phase 1 study tested whether olanzapine, an antipsychotic drug, can reduce the discomfort of tinnitus (ringing in the ears). Fifty adults with stable tinnitus for at least 6 months received either olanzapine or a placebo in a crossover design. The main goal was to see if olanzapine lowers tinnitus-related distress, measured by a standard questionnaire.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Olanzapine (Zyprexa) 5 mg oral tablet
What this could lead to
If it works, this could point toward a new way to reduce the distress of tinnitus for some people.
What could go wrong
This is a very early Phase 1 trial with only 50 participants. Olanzapine is an antipsychotic with side effects, and it may not work better than a placebo for tinnitus.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

50 people

The number who actually took part.

Started

Oct 2023

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

tinnitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Tinnitus Tinnitus, subjective

Contacts and locations

Locations

  • Research Ethics Committee (CEP)

    São Paulo, São Paulo, 05403000, Brazil

More trials for these conditions

Other studies related to the condition(s) this trial covers.