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Spoken Language Analysis for Bipolar Disorder
N/A
Recruiting
Led By Mark Frye, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Undergoing hospitalization, or boarding in the Emergency Department, for mania as determined by primary clinical staff
Documented clinical diagnosis for Bipolar I Disorder
Must not have
Individuals who have a guardian and are unable to consent for themselves
Current communicable disease requiring isolation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 48 hours after taking antimanic medications until up to end of subject participation approximately 1 month from enrollment
Awards & highlights
No Placebo-Only Group
Summary
This trial looks into how mania affects voice and speech: results may help improve care for people with bipolar disorder.
Who is the study for?
This study is for English-speaking individuals with a confirmed diagnosis of Bipolar I Disorder who are currently hospitalized or in the Emergency Department due to mania. Participants must be able to give informed consent and understand the study's objectives. Those with drug use, paranoia about electronic surveillance, developmental delays, involuntary hospitalization, communicable diseases requiring isolation, or risk of aggression cannot join.
What is being tested?
The trial aims to investigate changes in voice and speech patterns during manic episodes by conducting research interviews with participants experiencing mania as part of their bipolar disorder.
What are the potential side effects?
Since this trial involves research interviews rather than medication or medical procedures, there are no direct physical side effects expected from participating. However, discussing personal experiences during an interview may cause emotional discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently hospitalized or in the ER for mania as determined by my doctor.
Select...
I have been diagnosed with Bipolar I Disorder.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a guardian and cannot make medical decisions on my own.
Select...
I have a contagious disease that requires me to be isolated.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 48 hours after taking antimanic medications until up to end of subject participation approximately 1 month from enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 48 hours after taking antimanic medications until up to end of subject participation approximately 1 month from enrollment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acoustic Differences
Semantic Differences
Syntactical Differences
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Recording Session During HospitalizationExperimental Treatment1 Intervention
While inpatient, participants will undergo a research interview with recorded audio.
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,342 Previous Clinical Trials
3,062,312 Total Patients Enrolled
Mark Frye, MDPrincipal InvestigatorMayo Clinic
4 Previous Clinical Trials
273 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently hospitalized or in the ER for mania as determined by my doctor.I have a guardian and cannot make medical decisions on my own.I have a contagious disease that requires me to be isolated.You are considered likely to act aggressively.I have been diagnosed with Bipolar I Disorder.You cannot understand the purpose of the study based on a questionnaire.You believe that someone is spying on you using electronic devices.You have tested positive for amphetamines or cocaine in a urine drug test.You have a medical diagnosis of delayed development.
Research Study Groups:
This trial has the following groups:- Group 1: Recording Session During Hospitalization
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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