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OpenTrials
Completed

NCT Number: NCT05956340

A Study of Spoken Language in Mania

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

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Key information

Conditions

Manic Episode Bipolar I Disorder Mania Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Research interview

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Computational Analysis of Spoken Language in Mania

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 21, 2023
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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