A Study of Spoken Language in Mania

March 17, 2026 updated by: Mark Frye, Mayo Clinic

Computational Analysis of Spoken Language in Mania

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Recording Session During Hospitalization
While inpatient, participants will undergo a research interview with recorded audio.
Behavioral: Research interview
Research interview to capture speech data with high quality cardioid headset microphone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acoustic Differences
Time Frame: Approximately 48 hours after taking antimanic medications until up to end of subject participation approximately 1 month from enrollment
The raw audio data will be analyzed for change in pitch, variability of rhythm, and response time.
Approximately 48 hours after taking antimanic medications until up to end of subject participation approximately 1 month from enrollment
Syntactical Differences
Time Frame: Approximately 48 hours after taking antimanic medications until up to end of subject participation approximately 1 month from enrollment
Audio data will be transcribed using voice to text software and then analyzed for syntactical elements of speech including sentence structure and grammar.
Approximately 48 hours after taking antimanic medications until up to end of subject participation approximately 1 month from enrollment
Semantic Differences
Time Frame: Approximately 48 hours after taking antimanic medications until up to end of subject participation approximately 1 month from enrollment
Transcribed audio data will be analyzed for changes in verbosity, lexical diversity, and coherence on a sentence and paragraph level.
Approximately 48 hours after taking antimanic medications until up to end of subject participation approximately 1 month from enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Mark Frye, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2023

Primary Completion (Actual)

September 6, 2024

Study Completion (Actual)

September 9, 2024

Study Registration Dates

First Submitted

July 6, 2023

First Submitted That Met QC Criteria

July 13, 2023

First Posted (Actual)

July 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-010487

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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