Unipolar DepressionVAPRENCT04420793
Voice Changes During ECT
An observational study of Unipolar Depression and Bipolar Depression, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Depressed patients talk differently when they are depressed compared to when they are well. But it is hard to actually measure what the differences are. The study team will record voice samples from patients with mood disturbances, like depression, over the course of their receiving an electroconvulsive therapy (ECT)… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Unipolar Depression, Bipolar Depression, Bipolar Disorder, Manic
- What is being tested?
- Questionnaire
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2019to 17 Feb 2021
- Phase
- Observational
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing electroconvulsive therapy (ECT) at the Medical University of South Carolina on an outpatient or inpatient basis.
Who may be able to join
- Any candidate for electroconvulsive therapy who is about to initiate their ECT course at Medical University of South Carolina (MUSC) for a clinically indicated diagnosis
- Age 18 to 90 years old
- Able to speak and understand English
- Able to give consent to participate in the study
Who cannot join
- Any medical condition that limits the ability to speak or speak clearly, for example a history of head and/or neck cancer, spinal cord injury affecting speech, amyotrophic lateral sclerosis, or those with absence of critical anatomical structures involved in speech.
- Any voice characteristics that may limit the ability to speak English clearly including speech impediments or heavy accents (as evidenced by the pronunciation of the English language in such a non-standard way that research staff). If study staff have significant difficulty understanding the participant's responses in conversation, this may warrant exclusion.
- Patients who are receiving ECT by involuntary order, by order of their guardian, or by a court order, as evidenced by patient report or brief chart review.
- Patients who elect to not receive their full course of ECT at MUSC.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Voice Analysis in Patients Receiving Electroconvulsive Therapy
Depressed patients talk differently when they are depressed compared to when they are well. But it is hard to actually measure what the differences are. The study team will record voice samples from patients with mood disturbances, like depression, over the course of their receiving an electroconvulsive therapy (ECT) series. The study team will try and measure or quantify exactly what has changed in their speech and voice. The study team will choose ECT as it is one of the most effective and rapid treatment for depression. The study team will use a service provided by a company, NeuroLex, who has complex computer programs (artificial intelligence, AI) to analyze the voice samples.
- Being tested
- Questionnaire
- Keywords
- VAPRE
- Medical subject headings
- Depressive Disorder, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
3 voice recording tasks and 1 text entry task will be performed.
| Study group | Role | What they receive |
|---|---|---|
| ECT and Voice Recorded Group | This is an add-on study of voice samples to be gathered during ECT clinical treatments. The ONLY research procedures are four tasks on an online form, one text task and three voice recording tasks. These voice recordings will take place in a private room on the 5th floor of the Institute of Psychiatry on the same day of a patient's ECT treatment. The questionnaire will take less than 10 minutes. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acoustic feature: zero crossing rate
crossings per second
Measured: Throughout a course of electroconvulsive therapy (ECT) which may last between 2 and 7 weeks.
Acoustic feature: energy and entropy
decibels
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Acoustic feature: spectral centroid, spectral spread, spectral entropy, spectral flux, spectral rolloff
hertz
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Acoustic feature: Mel-Frequency Cepstral Coefficients, Chroma Vectors, and Chroma Deviation
unitless
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Linguistic features: question ratio, filler ratio, number ratio, type token ratio
unitless ratio
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Linguistic features: verb frequency, noun frequency, pronoun frequency, adverb frequency, adjective frequency, particle frequency, conjunction frequency, pronoun frequency
percentage
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Linguistic features: standardized word entropy
decibels/log(total word count)
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Linguistic features: Brunets index
W (lexical richness)
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Linguistic features: Honores statistic
R (lexical richness)
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Linguistic features: rate of speech
words per minute
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Meta-features: fatigue
Machine learning approach to evaluate binary outcome: fatigued or awake
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Meta-features: audio quality
Machine learning approach to evaluate binary outcome: bad or good
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Meta-features: sentiment
Machine learning approach to evaluate binary outcome: sad or happy
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Meta-features: stress
Machine learning approach to evaluate binary outcome: stressed or not stressed
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Meta-features: gender
Machine learning approach to evaluate binary outcome: male or female
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Meta-features: accent
Machine learning approach to evaluate a categorical outcome of accent region: england, indian, australian, etc.
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Meta-features: length
seconds
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Meta-features: age
Machine learning approach to evaluate estimated decade-age: 10s, 20s, 30s, 40s, 50s, 60s, 70s, 80s, 90s, etc.
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Comparing the voice feature(s) with greatest statistically significant change to Patient Health Questionnaire (PHQ)-9 scores
The voice feature(s) found to have changed most significantly will be compared to Patient Health Questionnaire-9 scores which approach a total score that is less than 8, indicative of reduced depressive symptoms throughout Electroconvulsive Therapy
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Acoustic Feature Specific Changes within and across sessions
Generalized mixed linear model will be used to evaluate which acoustic features change with P value threshold of <0.05
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Linguistic Feature Specific Changes within and across sessions
Generalized mixed linear model will be used to evaluate which linguistic features change with P value threshold of <0.05
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Meta-Feature Specific Changes within and across sessions
Generalized mixed linear model will be used to evaluate which meta features change with P value threshold of <0.05
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Secondary outcomes (30)
Acoustic Feature Specific Changes between sessions
Acoustic voice features will be evaluated using continuous averages using one sample t-tests and we will be testing the difference over time to a null hypothesis of 0 (for no change) in the one sample t-test.
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Linguistic Feature Specific Changes between sessions
Linguistic voice features will be evaluated using continuous averages using one sample t-tests and we will be testing the difference over time to a null hypothesis of 0 (for no change) in the one sample t-test.
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Meta-Feature Specific Changes between sessions
Meta-voice features will be evaluated using continuous averages using one sample t-tests and we will be testing the difference over time to a null hypothesis of 0 (for no change) in the one sample t-test.
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Age
years
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: inpatient/outpatient status
binary: inpatient or outpatient
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: gender
male, female, unspecified
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: race
african american, caucasian, hispanic, asian american, etc.
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Psychiatric diagnosis for ECT
Diagnosis indicated for receiving ECT
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: PHQ-9 score at each session
Total (0-27) on 9 question scale
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Psychiatric hospitalizations
Number
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Past Psychiatric Medication Trials
Number
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Current Psychiatric Medication Trials
Number
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Classes of Current Psychiatric Medications
Categorical: Sedative, Selective Serotonin Reuptake Inhibitor, etc.
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Suicidal Ideation at ECT consult
Binary: yes/no
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Past Suicide Attempts
Number
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Psychiatric Review of Systems
Descriptive, categorical
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Family Psychiatric History
Categorical regarding psychiatric diagnoses of family members
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Number of non-psychiatric medical diagnoses
Number
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Past non-psychiatric medication trials
Number
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Current non-psychiatric Medications
Number
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Tobacco use history
Binary (yes/no)
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Tobacco use pack year
pack-year (total years smoked*average packs per day)
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Prior ECT treatment
Binary (yes/no)
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: total # of prior ECT treatments for response in the past
Numerical
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Prior transcranial magnetic stimulation (TMS) treatment
Binary (yes/no)
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Prior response to ECT or TMS
Categorical
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data against voice features
We will evaluate voice features with statistically significant changes against respective participant chart review data using a general linear model with a clustering component for repeated measures which may also be applied to contrast statements evaluating overall change over time (from baseline to end).
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Generating ROC curves: stress
Clinically determined stress level (mood) will be compared to meta-feature extractions of stressed vs. not stressed from voice recordings will be used to calculate an area under the receiver operating curve (AUOC)
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Generating ROC curves: fatigue
Clinically determined fatigue (motor) will be compared to meta-feature extractions of fatigued vs. awake from voice recordings will be used to calculate an area under the receiver operating curve (AUOC)
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Generating ROC curves: sentiment
Clinically determined sentiment (affect and mood) will be compared to meta-feature extractions of happy vs. sad from voice recordings will be used to calculate an area under the receiver operating curve (AUOC)
Measured: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start7 Nov 2019
- Primary completion17 Feb 2021
- Study completion17 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unipolar DepressionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sean Christensen, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420793
- Sponsor's protocol ID
- 00089198
- Acronym
- VAPRE
- Status last verified
- Oct 2024
- First submitted
- 10 Mar 2020
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voice Analysis in Patients Receiving Electroconvulsive Therapy
- ClinicalTrials.gov ID
- NCT04420793
- Acronym / sponsor ID
- VAPRE / 00089198
- Keywords
- VAPRE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 17 Feb 2021 (actual)
- Study completion
- 17 Feb 2021 (actual)
- First posted
- 9 Jun 2020 (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.
Depressed patients talk differently when they are depressed compared to when they are well. But it is hard to actually measure what the differences are. The study team will record voice samples from patients with mood disturbances, like depression, over the course of their receiving an electroconvulsive therapy (ECT) series. The study team will try and measure or quantify exactly what has changed in their speech and voice. The study team will choose ECT as it is one of the most effective and rapid treatment for depression. The study team will use a service provided by a company, NeuroLex, who has complex computer programs (artificial intelligence, AI) to analyze the voice samples.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECT and Voice Recorded Group | – | Other: QuestionnaireThis is an add-on study of voice samples to be gathered during ECT clinical treatments. The ONLY research procedures are four tasks on an online form, one text task and three voice recording tasks. These voice recordings will take place in a private room on the 5th floor of the Institute of Psychiatry on the same day of a patient's ECT treatment. The questionnaire will take less than 10 minutes. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing electroconvulsive therapy (ECT) at the Medical University of South Carolina on an outpatient or inpatient basis.
Key inclusion criteria (4 listed)
- Any candidate for electroconvulsive therapy who is about to initiate their ECT course at Medical University of South Carolina (MUSC) for a clinically indicated diagnosis
- Age 18 to 90 years old
- Able to speak and understand English
- Able to give consent to participate in the study
Key exclusion criteria (4 listed)
- Any medical condition that limits the ability to speak or speak clearly, for example a history of head and/or neck cancer, spinal cord injury affecting speech, amyotrophic lateral sclerosis, or those with absence of critical anatomical structures involved in speech.
- Any voice characteristics that may limit the ability to speak English clearly including speech impediments or heavy accents (as evidenced by the pronunciation of the English language in such a non-standard way that research staff). If study staff have significant difficulty understanding the participant's responses in conversation, this may warrant exclusion.
- Patients who are receiving ECT by involuntary order, by order of their guardian, or by a court order, as evidenced by patient report or brief chart review.
- Patients who elect to not receive their full course of ECT at MUSC.
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 |
|---|---|---|
| Questionnaire3 voice recording tasks and 1 text entry task will be performed. | Other | ECT and Voice Recorded Group |
Primary outcome
Acoustic feature: zero crossing rate
Time frame: Throughout a course of electroconvulsive therapy (ECT) which may last between 2 and 7 weeks.
crossings per second
Acoustic feature: energy and entropy
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
decibels
Acoustic feature: spectral centroid, spectral spread, spectral entropy, spectral flux, spectral rolloff
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
hertz
Acoustic feature: Mel-Frequency Cepstral Coefficients, Chroma Vectors, and Chroma Deviation
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
unitless
Linguistic features: question ratio, filler ratio, number ratio, type token ratio
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
unitless ratio
Linguistic features: verb frequency, noun frequency, pronoun frequency, adverb frequency, adjective frequency, particle frequency, conjunction frequency, pronoun frequency
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
percentage
Linguistic features: standardized word entropy
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
decibels/log(total word count)
Linguistic features: Brunets index
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
W (lexical richness)
Linguistic features: Honores statistic
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
R (lexical richness)
Linguistic features: rate of speech
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
words per minute
Meta-features: fatigue
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Machine learning approach to evaluate binary outcome: fatigued or awake
Meta-features: audio quality
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Machine learning approach to evaluate binary outcome: bad or good
Meta-features: sentiment
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Machine learning approach to evaluate binary outcome: sad or happy
Meta-features: stress
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Machine learning approach to evaluate binary outcome: stressed or not stressed
Meta-features: gender
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Machine learning approach to evaluate binary outcome: male or female
Meta-features: accent
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Machine learning approach to evaluate a categorical outcome of accent region: england, indian, australian, etc.
Meta-features: length
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
seconds
Meta-features: age
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Machine learning approach to evaluate estimated decade-age: 10s, 20s, 30s, 40s, 50s, 60s, 70s, 80s, 90s, etc.
Comparing the voice feature(s) with greatest statistically significant change to Patient Health Questionnaire (PHQ)-9 scores
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
The voice feature(s) found to have changed most significantly will be compared to Patient Health Questionnaire-9 scores which approach a total score that is less than 8, indicative of reduced depressive symptoms throughout Electroconvulsive Therapy
Acoustic Feature Specific Changes within and across sessions
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Generalized mixed linear model will be used to evaluate which acoustic features change with P value threshold of <0.05
Linguistic Feature Specific Changes within and across sessions
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Generalized mixed linear model will be used to evaluate which linguistic features change with P value threshold of <0.05
Meta-Feature Specific Changes within and across sessions
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Generalized mixed linear model will be used to evaluate which meta features change with P value threshold of <0.05
30 secondary outcomes
Acoustic Feature Specific Changes between sessions
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Linguistic Feature Specific Changes between sessions
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Meta-Feature Specific Changes between sessions
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Age
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: inpatient/outpatient status
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: gender
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: race
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Psychiatric diagnosis for ECT
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: PHQ-9 score at each session
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Psychiatric hospitalizations
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Past Psychiatric Medication Trials
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Current Psychiatric Medication Trials
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Classes of Current Psychiatric Medications
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Suicidal Ideation at ECT consult
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Past Suicide Attempts
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Psychiatric Review of Systems
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Family Psychiatric History
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Number of non-psychiatric medical diagnoses
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Past non-psychiatric medication trials
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Current non-psychiatric Medications
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Tobacco use history
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Tobacco use pack year
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Prior ECT treatment
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: total # of prior ECT treatments for response in the past
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Prior transcranial magnetic stimulation (TMS) treatment
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data: Prior response to ECT or TMS
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Patient Chart Review Data against voice features
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Generating ROC curves: stress
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Generating ROC curves: fatigue
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Generating ROC curves: sentiment
Time frame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
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 24 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Unipolar Depression
Enrolling by invitationObservational study
Digital Phenotypes for Predicting Depression_Validation
Major Depressive Disorder, Bipolar I Disorder
Recruiting
Understanding the Neural Underpinnings of Risk-Taking Behavior in Psychiatric Disease
Depression - Major Depressive Disorder
RecruitingPhase 2
Cognitive Dysfunction and Inflammation in Depression: Experimental Inhibition Via Infliximab
Depressive Disorder, Major, Inflammation
RecruitingObservational study
Tracking Response to Antidepressants in Advance of Investigational Trials
Major Depressive Disorder
Not yet recruiting
Sedation and Guided Education for Depression Study
Major Depressive Disorder (MDD)
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.
Sean Christensen, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unipolar Depression and Bipolar Depression, run by Medical University of South Carolina 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 4 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 24 Oct 2024. 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 feature: zero crossing rate (time frame: Throughout a course of electroconvulsive therapy (ECT) which may last between 2 and 7 weeks.). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Oct 2024.