TinnitusPhase 1OLANZAP_TINNCT07190482
Treatment of Tinnitus With Olanzapine
A Phase 1 study testing Olanzapine 5 Mg ORAL TABLET in people with Tinnitus and Tinnitus, Subjective, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tinnitus, Tinnitus, Subjective
- What is being tested?
- Olanzapine 5 Mg ORAL TABLET
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2023to 20 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Tinnitus With Olanzapine: A Randomized Crossover Versus Placebo Study
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.
Read the 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
- Being tested
- Olanzapine 5 Mg ORAL TABLET, Placebo Drug
- Keywords
- TINNITUS, OLANZAPINE
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olanzapine 5 Mg ORAL TABLETDrug
Also called Zyprexa, OLZ
OLANZAPINE ARM
Placebo DrugDrug
Also called Sham treatment
placebo administered for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| OLANZAPINE ARM | Active comparator | olanzapine 5 mg/day administered for 8 weeks Receives: Drug: Olanzapine 5 Mg ORAL TABLET |
| PLACEBO ARM | Placebo comparator | placebo administered for 8 weeks Receives: Drug: Placebo Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of olanzapine in reducing tinnitus symptoms in a randomized placebo-controlled crossover trial
- Tinnitus Handicap Inventory (THI): A 25-item questionnaire measuring tinnitus-related distress. Scores range from 0 to 100, with higher scores indicating greater handicap.
Measured: From enrollment to the end of treatment at 12 weeks
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
- Visual Analog Scales (VAS): Patients rated tinnitus loudness and distress on 10-point scales (0 = none; 10 = extreme).
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start1 Oct 2023
- Primary completion20 Dec 2024
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- To evaluate the efficacy of olanzapine in reducing tinnitus symptoms in a randomized placebo-controlled crossover trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeanne Oiticica, University of Sao Paulo
- Investigators
- Research Ethics Committee (CEP) Research Ethics Committee (CEP), Principal investigator, Research Ethics Committee (CEP)JEANNE OITICICA, MD PhD, Study chair, Research Ethics Committee (CEP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190482
- Sponsor's protocol ID
- 6.414.085
- Acronym
- OLANZAP_TIN
- Status last verified
- Sep 2026
- First submitted
- 12 Sep 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Tinnitus With Olanzapine: A Randomized Crossover Versus Placebo Study
- ClinicalTrials.gov ID
- NCT07190482
- Acronym / sponsor ID
- OLANZAP_TIN / 6.414.085
- Conditions
- Tinnitus, Tinnitus, Subjective
- Keywords
- TINNITUS, OLANZAPINE
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- To evaluate the efficacy of olanzapine in reducing tinnitus symptoms in a randomized placebo-controlled crossover trial
| Arm | Type | Receives |
|---|---|---|
| OLANZAPINE ARM | Active comparator | Drug: Olanzapine 5 Mg ORAL TABLETolanzapine 5 mg/day administered for 8 weeks |
| PLACEBO ARM | Placebo comparator | Drug: Placebo Drugplacebo administered for 8 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olanzapine 5 Mg ORAL TABLETAlso: Zyprexa, OLZOLANZAPINE ARM | Drug | OLANZAPINE ARM |
| Placebo DrugAlso: Sham treatmentplacebo administered for 8 weeks | Drug | PLACEBO ARM |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Research Ethics Committee (CEP) Research Ethics Committee (CEP) principal investigator
Research Ethics Committee (CEP)
JEANNE OITICICA, MD PhD study chair
Research Ethics Committee (CEP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Olanzapine 5 Mg ORAL TABLET in people with Tinnitus and Tinnitus, Subjective, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.