Clinical Trials Directory

Trials / Completed

CompletedNCT03857438

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

Status
Completed
Phase
Study type
Observational
Enrollment
89 (actual)
Sponsor
Istanbul Saglik Bilimleri University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGOngoing treatment for bipolar maniaPrescribed by the following doctor during hospitalization and after discharge
DIAGNOSTIC_TESTAudiovisual recording during guided presentationSeven 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

Timeline

Start date
2016-09-30
Primary completion
2017-02-20
Completion
2017-07-08
First posted
2019-02-28
Last updated
2019-02-28

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT03857438. Inclusion in this directory is not an endorsement.