A Study of Spoken Language in Mania

NCT ID: NCT05956340

Last Updated: 2025-09-03

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-27

Study Completion Date

2026-01-31

Brief Summary

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This research is being done to find if there are changes with voice and speech during episodes of mania.

Detailed Description

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Conditions

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Manic Episode Bipolar I Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Recording Session During Hospitalization

While inpatient, participants will undergo a research interview with recorded audio.

Group Type EXPERIMENTAL

Research interview

Intervention Type BEHAVIORAL

Research interview to capture speech data with high quality cardioid headset microphone

Interventions

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Research interview

Research interview to capture speech data with high quality cardioid headset microphone

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Provision of informed consent before any study procedures are performed
* English speaker
* Documented clinical diagnosis for Bipolar I Disorder
* Undergoing hospitalization, or boarding in the Emergency Department, for mania as determined by primary clinical staff

Exclusion Criteria

* Positive urine drug screen for amphetamines or cocaine.
* Expressing paranoid delusions regarding electronic surveillance.
* Documented clinical diagnosis of developmental delay.
* Currently involuntarily hospitalized.
* Deemed at risk for aggression.
* Failure to comprehend study objectives via comprehension questionnaire.
* Individuals who have a guardian and are unable to consent for themselves.
* Current communicable disease requiring isolation.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Mark Frye

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark Frye, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Minnesota

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jeremiah Joyce, MD, MS

Role: CONTACT

507-284-0557

Facility Contacts

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Jeremiah Joyce, MD

Role: primary

Related Links

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Other Identifiers

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22-010487

Identifier Type: -

Identifier Source: org_study_id

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