Treatment of Tinnitus With Olanzapine (OLANZAP_TIN)

University of Sao Paulo

Status and phase: Completed; Phase 1

Conditions: Tinnitus, Subjective; Tinnitus

Treatments: Drug: Olanzapine 5 Mg ORAL TABLET; Drug: Placebo Drug

Study type: Interventional

Funder types: Other

Identifiers

NCT07190482

6.414.085

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

OLANZAPINE ARM

Active Comparator group

Description:

olanzapine 5 mg/day administered for 8 weeks

Treatment:

Drug: Olanzapine 5 Mg ORAL TABLET

PLACEBO ARM

Placebo Comparator group

Description:

placebo administered for 8 weeks

Treatment:

Drug: Placebo Drug