NCT03857438

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2018

Completed
11 months until next milestone

First Posted

Study publicly available on registry

February 28, 2019

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

5 months

First QC Date

April 15, 2018

Last Update Submit

February 25, 2019

Conditions

Keywords

Bipolar and Related DisordersMood DisordersMental DisordersBehavioral SymptomsCognitive functionsSimulation

Outcome Measures

Primary Outcomes (7)

  • Treatment response

    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 1. Remission: Yt \<= 7 2. Hypomania: 7 \< Yt \< 20 3. Mania: Yt \>= 20.

    from baseline until 3rd month

  • Changes in visual features

    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

    Baseline and 3rd month

  • Changes in audio features

    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.

    Baseline and 3rd month

  • in Stop Signal Test

    (milisecond) SST- Succesful Stop Ratio SST- go- Reaction Time SST- Stop Signal Delay SST- Stop Signal Reaction Time SST- Total Correct

    Baseline and 3rd month

  • Changes in Rapid Visual Processing

    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)

    Baseline and 3rd month

  • in Cambridge Gambling Task

    (milisecond) CGT Quality of decision making CGT Deliberation time CGT Delay aversion CGT Overall proportion bet

    Baseline and 3rd month

  • Changes in Emotion Recognition Test

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

    Baseline and 3rd month

Study Arms (2)

Bipolar Mania

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

Drug: Ongoing treatment for bipolar maniaDiagnostic Test: Audiovisual recording during guided presentation

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.

Diagnostic Test: Audiovisual recording during guided presentation

Interventions

Prescribed by the following doctor during hospitalization and after discharge

Bipolar Mania

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

Bipolar ManiaHealthy Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Bipolar mania patients from the inpatient service Healthy controls from the community around hospital

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • presence of family history of mood or psychotic disorder,
  • presence of psychiatric disorder during interview or in the past.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SBU Erenkoy Mental State Hospital

Istanbul, 34736, Turkey (Türkiye)

Location

Related Publications (2)

  • 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/

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

    BACKGROUND

MeSH Terms

Conditions

Bipolar DisorderBipolar and Related DisordersMood DisordersMental DisordersBehavioral Symptoms

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Heysem Kaya, Ass Prof

    Namik Kemal University

    PRINCIPAL INVESTIGATOR
  • Ali A Salah, Ass Prof

    Bogazici University

    STUDY CHAIR
  • Hüseyin Gülec, Ass Prof

    İstanbul Saglık Bilimleri University

    STUDY CHAIR
  • Elvan Ciftci, MD PhD

    İstanbul Saglık Bilimleri University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 15, 2018

First Posted

February 28, 2019

Study Start

September 30, 2016

Primary Completion

February 20, 2017

Study Completion

July 8, 2017

Last Updated

February 28, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will share

The database will be introduced in AVEC 2018 competition and shared with participants. After the competition the databese will be shared under the special EULA permission.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
5 years
Access Criteria
EULA permission
More information

Locations