Treatment of Tinnitus With Olanzapine

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07190482

Acronym

OLANZAP_TIN

Enrollment

Registered

2025-09-24

Start date

2023-10-01

Completion date

2025-01-20

Last updated

2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinnitus, Tinnitus, Subjective

Keywords

TINNITUS, OLANZAPINE

Brief 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.

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.

Interventions

DRUGOlanzapine 5 Mg ORAL TABLET

OLANZAPINE ARM

DRUGPlacebo Drug

placebo administered for 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

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

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Evaluate the efficacy of olanzapine in reducing tinnitus symptoms in a randomized placebo-controlled crossover trial	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

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

Countries

Brazil

Contacts

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

Research Ethics Committee (CEP)

STUDY_CHAIRJEANNE OITICICA, MD PhD