Study Results
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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COMPLETED
PHASE1
50 participants
INTERVENTIONAL
2023-10-01
2025-01-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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OLANZAPINE ARM
olanzapine 5 mg/day administered for 8 weeks
Olanzapine 5 Mg ORAL TABLET
OLANZAPINE ARM
PLACEBO ARM
placebo administered for 8 weeks
Placebo Drug
placebo administered for 8 weeks
Interventions
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Olanzapine 5 Mg ORAL TABLET
OLANZAPINE ARM
Placebo Drug
placebo administered for 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stable tinnitus symptoms over the past 3 months
* Willingness to participate and provide informed consent
* Age between 18 and 70 years
Exclusion Criteria
* 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)
18 Years
70 Years
ALL
No
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Jeanne Oiticica
MD PhD
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
Countries
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Other Identifiers
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6.414.085
Identifier Type: -
Identifier Source: org_study_id
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