Clinical trial NCT03857438: Correlation of Audiovisual Features With Clinical Variables and Neurocognitive Functions in Bipolar Disorder, Mania
Official title: Correlation of Audiovisual Features With Clinical Variables and Neurocognitive Functions in Bipolar Disorder, Mania
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Istanbul Saglik Bilimleri University
Sponsor class: OTHER
Collaborators: name: Namik Kemal University
name: Bosphorus University
First posted: 2019-02-28
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Bipolar mania patients from the inpatient service Healthy controls from the community around hospital

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Treatment response
timeFrame: from baseline until 3rd month
measure: Changes in visual features
timeFrame: Baseline and 3rd month
measure: Changes in audio features
timeFrame: Baseline and 3rd month
measure: in Stop Signal Test
timeFrame: Baseline and 3rd month
measure: Changes in Rapid Visual Processing
timeFrame: Baseline and 3rd month
measure: in Cambridge Gambling Task
timeFrame: Baseline and 3rd month
measure: Changes in Emotion Recognition Test
timeFrame: Baseline and 3rd month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: SBU Erenkoy Mental State Hospital
Study officials:
affiliation: Namik Kemal University
name: Heysem Kaya, Ass Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Bogazici University
name: Ali A Salah, Ass Prof
role: STUDY_CHAIR
affiliation: İstanbul Saglık Bilimleri University
name: Hüseyin Gülec, Ass Prof
role: STUDY_CHAIR
affiliation: İstanbul Saglık Bilimleri University
name: Elvan Ciftci, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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/
citation: Çiftçi E, Kaya H, Güleç H and Salah AA Potential audio treatment predictors for bipolar mania Psychiatry and Clinical Psychopharmacology Supplementary