Manic EpisodeNCT05956340
A Study of Spoken Language in Mania
A study testing Research interview in people with Manic Episode and Bipolar I Disorder, run by Mayo Clinic at 1 site in United States.
Trial summary
This research is being done to find if there are changes with voice and speech during episodes of mania. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Manic Episode, Bipolar I Disorder
- What is being tested?
- Research interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2023to 9 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Manic Episode, Bipolar I Disorder
- Being tested
- Research interview
- Medical subject headings
- Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Research interviewBehavioural
Research interview to capture speech data with high quality cardioid headset microphone
| Study group | Role | What they receive |
|---|---|---|
| Recording Session During Hospitalization | Experimental | While inpatient, participants will undergo a research interview with recorded audio. Receives: Behavioral: Research interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acoustic Differences
The raw audio data will be analyzed for change in pitch, variability of rhythm, and response time.
Measured: Approximately 48 hours after taking antimanic medications until up to end of subject participation approximately 1 month from enrollment
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.
Measured: Approximately 48 hours after taking antimanic medications until up to end of subject participation approximately 1 month from enrollment
Semantic Differences
Transcribed audio data will be analyzed for changes in verbosity, lexical diversity, and coherence on a sentence and paragraph level.
Measured: Approximately 48 hours after taking antimanic medications until up to end of subject participation approximately 1 month from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start27 Apr 2023
- Primary completion6 Sep 2024
- Study completion9 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Manic EpisodeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Frye, Mayo Clinic
- Investigators
- Mark Frye, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956340
- Sponsor's protocol ID
- 22-010487
- Status last verified
- Mar 2026
- First submitted
- 6 Jul 2023
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Joyce JB, Ayala IN, Mishra S, Chatzisofroniou G, Clemens E, Yu H, Kendall T, Attia Z, Lin B, Frye MA. Temporal elements of speech in mania. Transl Psychiatry. 2026 Aug 3;16(1):598. doi: 10.1038/s41398-026-04329-3.
PubMed 42957656
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computational Analysis of Spoken Language in Mania
- ClinicalTrials.gov ID
- NCT05956340
- Acronym / sponsor ID
- 22-010487
- Conditions
- Manic Episode, Bipolar I Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 6 Sep 2024 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being done to find if there are changes with voice and speech during episodes of mania.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recording Session During Hospitalization | Experimental | Behavioral: Research interviewWhile inpatient, participants will undergo a research interview with recorded audio. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Research interviewResearch interview to capture speech data with high quality cardioid headset microphone | Behavioural | Recording Session During Hospitalization |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Derived from this study: PubMed 42957656Joyce JB, Ayala IN, Mishra S, Chatzisofroniou G, Clemens E, Yu H, Kendall T, Attia Z, Lin B, Frye MA. Temporal elements of speech in mania. Transl Psychiatry. 2026 Aug 3;16(1):598. doi: 10.1038/s41398-026-04329-3.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Frye, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Research interview in people with Manic Episode and Bipolar I Disorder, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acoustic Differences (time frame: Approximately 48 hours after taking antimanic medications until up to end of subject participation approximately 1 month from enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05956340, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.