Correlation of Audiovisual Features With Clinical Variables and Neurocognitive Functions in Bipolar Disorder, Mania
1 other identifier
observational
89
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2016
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2017
CompletedFirst Submitted
Initial submission to the registry
April 15, 2018
CompletedFirst Posted
Study publicly available on registry
February 28, 2019
CompletedFebruary 28, 2019
February 1, 2019
5 months
April 15, 2018
February 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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 1. Remission: Yt \<= 7 2. Hypomania: 7 \< Yt \< 20 3. Mania: Yt \>= 20.
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
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.
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
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)
Baseline and 3rd month
in Cambridge Gambling Task
(milisecond) CGT Quality of decision making CGT Deliberation time CGT Delay aversion CGT Overall proportion bet
Baseline and 3rd month
Changes in Emotion Recognition Test
(rate of emotion prediction) Percent and numbers correct/incorrect prediction
Baseline and 3rd month
Study Arms (2)
Bipolar Mania
Diagnosis of BD type I, manic episode according to DSM-5 given by the following doctor
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.
Interventions
Prescribed by the following doctor during hospitalization and after discharge
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
Eligibility Criteria
Bipolar mania patients from the inpatient service Healthy controls from the community around hospital
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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.
- presence of family history of mood or psychotic disorder,
- presence of psychiatric disorder during interview or in the past.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Istanbul Saglik Bilimleri Universitylead
- Namik Kemal Universitycollaborator
- Bosphorus Universitycollaborator
Study Sites (1)
SBU Erenkoy Mental State Hospital
Istanbul, 34736, Turkey (Türkiye)
Related Publications (2)
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/
BACKGROUNDÇiftçi E, Kaya H, Güleç H and Salah AA Potential audio treatment predictors for bipolar mania Psychiatry and Clinical Psychopharmacology Supplementary
BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heysem Kaya, Ass Prof
Namik Kemal University
- STUDY CHAIR
Ali A Salah, Ass Prof
Bogazici University
- STUDY CHAIR
Hüseyin Gülec, Ass Prof
İstanbul Saglık Bilimleri University
- PRINCIPAL INVESTIGATOR
Elvan Ciftci, MD PhD
İstanbul Saglık Bilimleri University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 15, 2018
First Posted
February 28, 2019
Study Start
September 30, 2016
Primary Completion
February 20, 2017
Study Completion
July 8, 2017
Last Updated
February 28, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- 5 years
- Access Criteria
- EULA permission
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.