Bipolar Disorder, ManicNCT03857438
Correlation of Audiovisual Features With Clinical Variables and Neurocognitive Functions in Bipolar Disorder, Mania
An observational study of Bipolar Disorder, Manic and Artificial Intelligence, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to show the physiological changes during manic episode in bipolar mania how much they differentiate from remission and healthy control. Relation of audio-visual features as physiological changes and cognitive functions and clinical variables will be searched. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Manic, Artificial Intelligence, Neurocognition
- What is being tested?
- Ongoing treatment for bipolar mania and Audiovisual recording during guided presentation
- How many people
- 89 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2016to 8 Jul 2017
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Bipolar mania patients from the inpatient service Healthy controls from the community around hospital
Who may be able to join
- diagnosis of BD type I, manic episode according to DSM-5 [10] given by the following doctor,
- being informed of the purpose of the study and having given signed consent before enrollment.
Who cannot join
- being younger than 18 years or older than 60 years,
- showing low mental capacity during the interview
- expression of hallucinations and disruptive behaviors during the interview,
- presence of severe organic disease,
- presence of any organic disease that may affect cognition
- having less than five years of public education
Show all 12Show fewer
- diagnosis of substance or alcohol abuse in the last three months (except nicotine and caffeine)
- presence of cerebrovascular disorder, head trauma with longer duration of loss of consciousness, severe hemorrhage and dementia,
- having electroconvulsive therapy in the last one year.
- For the healthy control group, the following additional criteria were considered for exclusion
- presence of family history of mood or psychotic disorder,
- presence of psychiatric disorder during interview or in the past.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SBU Erenkoy Mental State Hospital
Istanbul, 34736
About this study
The aim of this study is to show the physiological changes during manic episode in bipolar mania how much they differentiate from remission and healthy control. Relation of audio-visual features as physiological changes and cognitive functions and clinical variables will be searched. The aim is to find biologic markers for predictors of treatment response via machine learning techniques to be able to reduce treatment resistance and give an idea for personalized treatment of bipolar patients.
Read the detailed description
The objective of this research protocol is to find audio-visual features which differentiates bipolar mani/ remission/ health/ simulation and predicts treatment response earlier and detect neurocognitive changes during mania/ remission and difference from the healthy control. During hospitalization in every follow up day (0th- 3rd- 7th- 14th- 28th day) and after discharge on the 3rd month, presence of depressive and manic features for patients was evaluated using Young Mania Rating Scale(YMRS) and Montgamery- Asberg Depresyon Scale (MADRS). Audiovisual recording is done by a video camera in every follow up day for patients and for healthy controls which includes also depression and mania simulation. Cambridge Neurophysiological Assessment Battery (CANTAB) were administered to both groups( for patients both in the manic phase and in the remission) to assess neurocognitive functions.
- Conditions
- Bipolar Disorder, Manic, Artificial Intelligence, Neurocognition, Treatment Resistant Disorders, Affective Computing, Multi- Modal Analysis
- Being tested
- Ongoing treatment for bipolar mania, Audiovisual recording during guided presentation
- Keywords
- Bipolar and Related Disorders, Mood Disorders, Mental Disorders, Behavioral Symptoms, Cognitive functions, Simulation
- Medical subject headings
- Bipolar Disorder, Bipolar and Related Disorders, Mood Disorders, Mental Disorders, Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ongoing treatment for bipolar maniaDrug
Prescribed by the following doctor during hospitalization and after discharge
Audiovisual recording during guided presentationDiagnostic test
Seven tasks such as explaining the reason to come to hospital/participate in the activity, describing happy and sad memories, counting up to thirty, explaining two emotion eliciting pictures
| Study group | Role | What they receive |
|---|---|---|
| Bipolar Mania | Diagnosis of BD type I, manic episode according to DSM-5 given by the following doctor Receives: Drug: Ongoing treatment for bipolar mania; Diagnostic Test: Audiovisual recording during guided presentation | |
| Healthy Control | showing normal mental capacity during interview, have more than five years of public education, no diagnosis of substance or alcohol abuse in the last three months (except nicotine and caffeine, no presence of family history of mood or psychotic disorder, and no presence of psychiatric disorder during interview or in the past, no presence of severe organic disease. Receives: Diagnostic Test: Audiovisual recording during guided presentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response
The proportion of Young Mania Rating Scale(YMRS) score ( at baseline to 3rd- 7th- 14th- 28th day and 3rd month ( Baseline scale/ Follow-up day scale) YMRS score utilized rating scales to assess manic symptoms ranged between 0-76
- Remission: Yt <= 7
- Hypomania: 7 < Yt < 20
- Mania: Yt >= 20.
Measured: from baseline until 3rd month
Changes in visual features
Functionals of appearance descriptors extracted from fine-tuned Deep Convolutional Neural Networks (DCNN), geometric features obtained using tracked facial landmarks (Unweighted Average Recall)
Geometric frame level 23 geometric features and apperance descriptors 4096 dimensional features from the last convolutional layer of the FER fine-tuned CNN which are summarized via mean and range functionals over sub-clips and the decisions are voted at video level, an UAR performance is obtained.
Feature vectors extracted from video is modelled using Partial Least Squares (PLS) regression and Extreme Learning Machines classifiers
Unweighted Average Recall (UAR), which is mean of class-wise recall scores, is commonly used as performance measure, instead of accuracy, which can be misleading in the case of class-imbalance
Measured: Baseline and 3rd month
Changes in audio features
Functionals of acoustic features extracted via openSMILE tool (Unweighted Average Recall)
Acoustic low level descriptors including prosody (energy, Fundamental Frequency - F0), voice quality features (jitter and shimmer), Mel Frequency Cepstral Coefficients, which are commonly used in many speech technologies from audio, we use the 76-dimensional standard feature set used in the INTERSPEECH 2010 paralinguistic challenge as baseline.
The second is our proposed set of 10 functionals, Mean, standard deviation, curvature coefficient , slope and offset , minimum value and its relative position, maximum value and its relative position, and the range
Feature vectors extracted from audio is modelled using Partial Least Squares (PLS) regression and Extreme Learning Machines classifiers.
Measured: Baseline and 3rd month
in Stop Signal Test
(milisecond) SST- Succesful Stop Ratio SST- go- Reaction Time SST- Stop Signal Delay SST- Stop Signal Reaction Time SST- Total Correct
Measured: Baseline and 3rd month
Changes in Rapid Visual Processing
RVP A' (A prime) is the signal detection measure of sensitivity to the target, regardless of response tendency (range 0.00 to 1.00; bad to good).
RVP B'' (B double prime) is the signal detection measure of the strength of trace required to elicit a response (range -1.00 to +1.00)
Measured: Baseline and 3rd month
in Cambridge Gambling Task
(milisecond) CGT Quality of decision making CGT Deliberation time CGT Delay aversion CGT Overall proportion bet
Measured: Baseline and 3rd month
Changes in Emotion Recognition Test
(rate of emotion prediction) Percent and numbers correct/incorrect prediction
Measured: Baseline and 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start30 Sep 2016
- Primary completion20 Feb 2017
- Study completion8 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bipolar Disorder, ManicStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Collaborators
- Namik Kemal University, Bosphorus University
- Responsible party
- Principal investigator, Elvan Çiftçi, Istanbul Saglik Bilimleri University
- Investigators
- Heysem Kaya, Ass Prof, Principal investigator, Namik Kemal UniversityAli A Salah, Ass Prof, Study chair, Bogazici UniversityHüseyin Gülec, Ass Prof, Study chair, İstanbul Saglık Bilimleri UniversityElvan Ciftci, MD PhD, Principal investigator, İstanbul Saglık Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857438
- Sponsor's protocol ID
- BipolarAI
- Status last verified
- Feb 2019
- First submitted
- 15 Apr 2018
- Last updated
- 28 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The database will be introduced in AVEC 2018 competition and shared with participants. After the competition the databese will be shared under the special EULA permission.
Publications
Ciftci E, Kaya H, Gulec H, Salah AA (2018) The Turkish Audio-Visual Bipolar Disorder Corpus. In: 2018 First Asian Conference on Affective Computing and Intelligent Interaction (ACII Asia), pp 1-6. IEEE. Available at: https://ieeexplore.ieee.org/document/8470362/
Çiftçi E, Kaya H, Güleç H and Salah AA Potential audio treatment predictors for bipolar mania Psychiatry and Clinical Psychopharmacology Supplementary
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Audiovisual Features With Clinical Variables and Neurocognitive Functions in Bipolar Disorder, Mania
- ClinicalTrials.gov ID
- NCT03857438
- Acronym / sponsor ID
- BipolarAI
- Conditions
- Bipolar Disorder, Manic, Artificial Intelligence, Neurocognition, Treatment Resistant Disorders, Affective Computing, Multi- Modal Analysis
- Keywords
- Bipolar and Related Disorders, Mood Disorders, Mental Disorders, Behavioral Symptoms, Cognitive functions, Simulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Collaborators
- Namik Kemal University, Bosphorus University
- Study start
- 30 Sep 2016 (actual)
- Primary completion
- 20 Feb 2017 (actual)
- Study completion
- 8 Jul 2017 (actual)
- First posted
- 28 Feb 2019 (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.
The aim of this study is to show the physiological changes during manic episode in bipolar mania how much they differentiate from remission and healthy control. Relation of audio-visual features as physiological changes and cognitive functions and clinical variables will be searched. The aim is to find biologic markers for predictors of treatment response via machine learning techniques to be able to reduce treatment resistance and give an idea for personalized treatment of bipolar patients.
Detailed description
The objective of this research protocol is to find audio-visual features which differentiates bipolar mani/ remission/ health/ simulation and predicts treatment response earlier and detect neurocognitive changes during mania/ remission and difference from the healthy control. During hospitalization in every follow up day (0th- 3rd- 7th- 14th- 28th day) and after discharge on the 3rd month, presence of depressive and manic features for patients was evaluated using Young Mania Rating Scale(YMRS) and Montgamery- Asberg Depresyon Scale (MADRS). Audiovisual recording is done by a video camera in every follow up day for patients and for healthy controls which includes also depression and mania simulation. Cambridge Neurophysiological Assessment Battery (CANTAB) were administered to both groups( for patients both in the manic phase and in the remission) to assess neurocognitive functions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bipolar Mania | – | Drug: Ongoing treatment for bipolar mania, Diagnostic Test: Audiovisual recording during guided presentationDiagnosis of BD type I, manic episode according to DSM-5 given by the following doctor |
| Healthy Control | – | Diagnostic Test: Audiovisual recording during guided presentationshowing normal mental capacity during interview, have more than five years of public education, no diagnosis of substance or alcohol abuse in the last three months (except nicotine and caffeine, no presence of family history of mood or psychotic disorder, and no presence of psychiatric disorder during interview or in the past, no presence of severe organic disease. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Bipolar mania patients from the inpatient service Healthy controls from the community around hospital
Key inclusion criteria (2 listed)
- diagnosis of BD type I, manic episode according to DSM-5 [10] given by the following doctor,
- being informed of the purpose of the study and having given signed consent before enrollment.
Key exclusion criteria (12 listed)
- being younger than 18 years or older than 60 years,
- showing low mental capacity during the interview
- expression of hallucinations and disruptive behaviors during the interview,
- presence of severe organic disease,
- presence of any organic disease that may affect cognition
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 |
|---|---|---|
| Ongoing treatment for bipolar maniaPrescribed by the following doctor during hospitalization and after discharge | Drug | Bipolar Mania |
| Audiovisual recording during guided presentationSeven tasks such as explaining the reason to come to hospital/participate in the activity, describing happy and sad memories, counting up to thirty, explaining two emotion eliciting pictures | Diagnostic test | Bipolar Mania, Healthy Control |
Primary outcome
Treatment response
Time frame: from baseline until 3rd month
The proportion of Young Mania Rating Scale(YMRS) score ( at baseline to 3rd- 7th- 14th- 28th day and 3rd month ( Baseline scale/ Follow-up day scale) YMRS score utilized rating scales to assess manic symptoms ranged between 0-76 1. Remission: Yt <= 7 2. Hypomania: 7 < Yt < 20 3. Mania: Yt >= 20.
Changes in visual features
Time frame: Baseline and 3rd month
Functionals of appearance descriptors extracted from fine-tuned Deep Convolutional Neural Networks (DCNN), geometric features obtained using tracked facial landmarks (Unweighted Average Recall) Geometric frame level 23 geometric features and apperance descriptors 4096 dimensional features from the last convolutional layer of the FER fine-tuned CNN which are summarized via mean and range functionals over sub-clips and the decisions are voted at video level, an UAR performance is obtained. Feature vectors extracted from video is modelled using Partial Least Squares (PLS) regression and Extreme Learning Machines classifiers Unweighted Average Recall (UAR), which is mean of class-wise recall scores, is commonly used as performance measure, instead of accuracy, which can be misleading in the case of class-imbalance
Changes in audio features
Time frame: Baseline and 3rd month
Functionals of acoustic features extracted via openSMILE tool (Unweighted Average Recall) Acoustic low level descriptors including prosody (energy, Fundamental Frequency - F0), voice quality features (jitter and shimmer), Mel Frequency Cepstral Coefficients, which are commonly used in many speech technologies from audio, we use the 76-dimensional standard feature set used in the INTERSPEECH 2010 paralinguistic challenge as baseline. The second is our proposed set of 10 functionals, Mean, standard deviation, curvature coefficient , slope and offset , minimum value and its relative position, maximum value and its relative position, and the range Feature vectors extracted from audio is modelled using Partial Least Squares (PLS) regression and Extreme Learning Machines classifiers.
in Stop Signal Test
Time frame: Baseline and 3rd month
(milisecond) SST- Succesful Stop Ratio SST- go- Reaction Time SST- Stop Signal Delay SST- Stop Signal Reaction Time SST- Total Correct
Changes in Rapid Visual Processing
Time frame: Baseline and 3rd month
RVP A' (A prime) is the signal detection measure of sensitivity to the target, regardless of response tendency (range 0.00 to 1.00; bad to good). RVP B'' (B double prime) is the signal detection measure of the strength of trace required to elicit a response (range -1.00 to +1.00)
in Cambridge Gambling Task
Time frame: Baseline and 3rd month
(milisecond) CGT Quality of decision making CGT Deliberation time CGT Delay aversion CGT Overall proportion bet
Changes in Emotion Recognition Test
Time frame: Baseline and 3rd month
(rate of emotion prediction) Percent and numbers correct/incorrect prediction
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 28 Feb 2019.
- BackgroundCiftci E, Kaya H, Gulec H, Salah AA (2018) The Turkish Audio-Visual Bipolar Disorder Corpus. In: 2018 First Asian Conference on Affective Computing and Intelligent Interaction (ACII Asia), pp 1-6. IEEE. Available at: https://ieeexplore.ieee.org/document/8470362/
- BackgroundÇiftçi E, Kaya H, Güleç H and Salah AA Potential audio treatment predictors for bipolar mania Psychiatry and Clinical Psychopharmacology Supplementary
- Individual participant dataSharing planned: Yes. The database will be introduced in AVEC 2018 competition and shared with participants. After the competition the databese will be shared under the special EULA permission.
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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.
Heysem Kaya, Ass Prof principal investigator
Namik Kemal University
Ali A Salah, Ass Prof study chair
Bogazici University
Hüseyin Gülec, Ass Prof study chair
İstanbul Saglık Bilimleri University
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 Bipolar Disorder, Manic and Artificial Intelligence, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
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 2 inclusion and 12 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 28 Feb 2019. 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 Turkey (Türkiye). 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?
Treatment response (time frame: from baseline until 3rd month). The study lists 7 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 NCT03857438, which also lists 2 linked publications.
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 28 Feb 2019.