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Completed

NCT Number: NCT03857438

Correlation of Audiovisual Features With Clinical Variables and Neurocognitive Functions in Bipolar Disorder, Mania

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.

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Key information

Conditions

Bipolar Disorder, Manic Affective Computing Artificial Intelligence Behavior Behavioral Symptoms Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders Multi- Modal Analysis Neurocognition Treatment Resistant Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

SBU Erenkoy Mental State Hospital

Istanbul, 34736, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

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.

Treatment and study plan

Ongoing treatment for bipolar mania

Drug

Prescribed by the following doctor during hospitalization and after discharge

Audiovisual recording during guided presentation

Diagnostic 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

Primary outcomes

  1. 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

    • Remission: Yt <= 7
    • Hypomania: 7 < Yt < 20
    • Mania: Yt >= 20.

  2. 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

  3. 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.

  4. 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

  5. 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)

  6. 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

  7. Changes in Emotion Recognition Test

    Time frame: Baseline and 3rd month

    (rate of emotion prediction) Percent and numbers correct/incorrect prediction

Sponsors and collaborators

Lead sponsor

Istanbul Saglik Bilimleri University

Other

Collaborators

  • Bosphorus University
  • Namik Kemal University

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 28, 2019
Registry last updated
Feb 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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