A Study of Spoken Language in Mania

Mayo Clinic

Status: Enrolling

Conditions: Bipolar I Disorder; Manic Episode

Treatments: Behavioral: Research interview

Study type: Interventional

Funder types: Other

Identifiers

NCT05956340

22-010487

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Recording Session During Hospitalization

Experimental group

Description:

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

Treatment:

Behavioral: Research interview