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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OLANZAPINE ARM | Active Comparator | olanzapine 5 mg/day administered for 8 weeks |
|
| PLACEBO ARM | Placebo Comparator | placebo administered for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olanzapine 5 Mg ORAL TABLET | Drug | OLANZAPINE ARM |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From enrollment to the end of treatment at 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Research Ethics Committee (CEP) Research Ethics Committee (CEP) | Research Ethics Committee (CEP) | Principal Investigator |
| JEANNE OITICICA, MD PhD | Research Ethics Committee (CEP) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Ethics Committee (CEP) | São Paulo | São Paulo | 05403000 | Brazil |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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To evaluate the efficacy of olanzapine in reducing tinnitus symptoms in a randomized placebo-controlled crossover trial
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| Placebo Drug | Drug | placebo administered for 8 weeks |
|
|
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |