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

Istanbul Saglik Bilimleri University

Status: Completed

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

Treatments: Drug: Ongoing treatment for bipolar mania; Diagnostic Test: Audiovisual recording during guided presentation

Study type: Observational

Funder types: Other

Identifiers

NCT03857438

BipolarAI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 89 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

89 participants in 2 patient groups

Bipolar Mania

Description:

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

Treatment:

Diagnostic Test: Audiovisual recording during guided presentation

Drug: Ongoing treatment for bipolar mania

Healthy Control

Description:

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.

Treatment:

Diagnostic Test: Audiovisual recording during guided presentation