Treatment of Tinnitus With Olanzapine

NCT07190482 | Completed Phase 1 DMC

• 1 other identifier: 6.414.085
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus; Tinnitus, Subjective

Keywords

TINNITUS; OLANZAPINE

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

OLANZAPINE ARM

ACTIVE COMPARATOR

olanzapine 5 mg/day administered for 8 weeks

Drug: Olanzapine 5 Mg ORAL TABLET

PLACEBO ARM

PLACEBO COMPARATOR

placebo administered for 8 weeks

Drug: Placebo Drug

Interventions

Olanzapine 5 Mg ORAL TABLET DRUG

OLANZAPINE ARM

Also known as: Zyprexa, OLZ

OLANZAPINE ARM

Placebo Drug DRUG

placebo administered for 8 weeks

Also known as: Sham treatment

PLACEBO ARM

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Research Ethics Committee (CEP)

São Paulo, São Paulo, 05403000, Brazil

Location

MeSH Terms

Conditions

Tinnitus

Interventions

Olanzapine; Tablets

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

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

  Research Ethics Committee (CEP)

  PRINCIPAL INVESTIGATOR

• JEANNE OITICICA, MD PhD

  Research Ethics Committee (CEP)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

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

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 24, 2025
• Study Start: October 1, 2023
• Primary Completion: December 20, 2024
• Study Completion: January 20, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)