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

NCT ID: NCT03857438

Last Updated: 2019-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

89 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-07-08

Brief Summary

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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

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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

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Bipolar Disorder, Manic Artificial Intelligence Neurocognition Treatment Resistant Disorders Affective Computing Multi- Modal Analysis

Keywords

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Bipolar and Related Disorders Mood Disorders Mental Disorders Behavioral Symptoms Cognitive functions Simulation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Bipolar Mania

Diagnosis of BD type I, manic episode according to DSM-5 given by the following doctor

Ongoing treatment for bipolar mania

Intervention Type DRUG

Prescribed by the following doctor during hospitalization and after discharge

Audiovisual recording during guided presentation

Intervention Type 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

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.

Audiovisual recording during guided presentation

Intervention Type 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

Interventions

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Ongoing treatment for bipolar mania

Prescribed by the following doctor during hospitalization and after discharge

Intervention Type DRUG

Audiovisual recording during guided presentation

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Namik Kemal University

OTHER

Sponsor Role collaborator

Bosphorus University

UNKNOWN

Sponsor Role collaborator

Istanbul Saglik Bilimleri University

OTHER

Sponsor Role lead

Responsible Party

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Elvan Çiftçi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heysem Kaya, Ass Prof

Role: PRINCIPAL_INVESTIGATOR

Namik Kemal University

Ali A Salah, Ass Prof

Role: STUDY_CHAIR

Bogazici University

Hüseyin Gülec, Ass Prof

Role: STUDY_CHAIR

İstanbul Saglık Bilimleri University

Elvan Ciftci, MD PhD

Role: PRINCIPAL_INVESTIGATOR

İstanbul Saglık Bilimleri University

Locations

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SBU Erenkoy Mental State Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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/

Reference Type BACKGROUND

Çiftçi E, Kaya H, Güleç H and Salah AA Potential audio treatment predictors for bipolar mania Psychiatry and Clinical Psychopharmacology Supplementary

Reference Type BACKGROUND

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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BipolarAI

Identifier Type: -

Identifier Source: org_study_id