ClinicalTrials.gg
CompletedNCT05956340Updated Mar 19, 2026

A Study of Spoken Language in Mania

An interventional study of Research interview in Manic Episode and Bipolar I Disorder, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-19.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Manic Episode
  • Bipolar I Disorder

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03

In context

Mania

166 studies on the registry are indexed under Mania; 13 are open to participants now.

This study's enrollment of 17 is below the median of 89 across 138 interventional studies indexed under Mania.

Browse Mania studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.

Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Provision of 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    Recording Session During Hospitalization

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

    Behavioral: Research interview

Interventions

  • BehavioralResearch interview

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

06

What researchers measure

Primary outcomes

  1. Acoustic Differences

    The raw audio data will be analyzed for change in pitch, variability of rhythm, and response time.

    Time frame: Approximately 48 hours after taking antimanic medications until up to end of subject participation approximately 1 month from enrollment

  2. Syntactical Differences

    Audio data will be transcribed using voice to text software and then analyzed for syntactical elements of speech including sentence structure and grammar.

    Time frame: Approximately 48 hours after taking antimanic medications until up to end of subject participation approximately 1 month from enrollment

  3. Semantic Differences

    Transcribed audio data will be analyzed for changes in verbosity, lexical diversity, and coherence on a sentence and paragraph level.

    Time frame: Approximately 48 hours after taking antimanic medications until up to end of subject participation approximately 1 month from enrollment

07

Study locations

1 site
  • Mayo Clinic Minnesota
    Rochester, Minnesota 55905, United States
08

References and documents

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2023 to primary completion in Sep 2024, 16 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 6, 2023
First posted
Jul 21, 2023
StartActual
Apr 27, 2023
Primary completionActual
Sep 6, 2024
CompletionActual
Sep 9, 2024
Last update
Mar 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05956340
Lead sponsor
Mayo Clinic
Responsible party
Mark Frye (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Jul 21, 2023
Start date
Apr 27, 2023
Primary completion
Sep 6, 2024
Completion
Sep 9, 2024
Last update
Mar 19, 2026

Study contacts

Mark Frye, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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