Treatment of Tinnitus With Olanzapine

NCT ID: NCT07190482

Last Updated: 2025-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-01-20

Brief Summary

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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

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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

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Tinnitus Tinnitus, Subjective

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

To evaluate the efficacy of olanzapine in reducing tinnitus symptoms in a randomized placebo-controlled crossover trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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OLANZAPINE ARM

olanzapine 5 mg/day administered for 8 weeks

Group Type ACTIVE_COMPARATOR

Olanzapine 5 Mg ORAL TABLET

Intervention Type DRUG

OLANZAPINE ARM

PLACEBO ARM

placebo administered for 8 weeks

Group Type PLACEBO_COMPARATOR

Placebo Drug

Intervention Type DRUG

placebo administered for 8 weeks

Interventions

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Olanzapine 5 Mg ORAL TABLET

OLANZAPINE ARM

Intervention Type DRUG

Placebo Drug

placebo administered for 8 weeks

Intervention Type DRUG

Other Intervention Names

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Zyprexa OLZ Sham treatment

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Jeanne Oiticica

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Research Ethics Committee (CEP) Research Ethics Committee (CEP)

Role: PRINCIPAL_INVESTIGATOR

Research Ethics Committee (CEP)

JEANNE OITICICA, MD PhD

Role: STUDY_CHAIR

Research Ethics Committee (CEP)

Locations

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Research Ethics Committee (CEP)

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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6.414.085

Identifier Type: -

Identifier Source: org_study_id

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