A Study of Spoken Language in Mania

Not Applicable

Recruiting

• Conditions: Manic Episode; Bipolar I Disorder
• Interventions: Behavioral: Research interview

• Registration Number: NCT05956340
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-19
• Study First Submitted: 2023-07-06
• Study First Submitted QC: 2023-07-13
• Study First Posted: 2023-07-21
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09
• Primary Completion: 2025-05
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Recording Session During Hospitalization	Research interview	While inpatient, participants will undergo a research interview with recorded audio.

Primary Outcome Measures

Name	Time	Method
Acoustic Differences	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.
Syntactical Differences	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.
Semantic Differences	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.

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States