Neuronal Integrity in Bipolar Depression

April 22, 2021 updated by: Mehmet Diyaddin Güleken

Neuronal Integrity and Suicidality in Bipolar Depression: a Diffusion Tensor Imaging Study

The aim of this study is to examine the neurological unity in bipolar depression and to investigate white matter abnormalities that may contribute to etiology

Study Overview

Detailed Description

Bipolar disorder is a chronic mood disorder which is characterized by repetitive episodes, usually manifests through adolescence or early adulthood. It has a prevalence of approximately 2,5% with a 1:1 ratio of male and female. It is a disorder that may disrupt central nervous system functions such as cognition, thought, perception, affect, judgement, adaptation to the environment and behavioural regulation. It may manifest with various clinical onsets. Although etiology of bipolar disorder is still unknown, some biological factors such as BDNF, oxidative stress and structural changes of brain are proven to have a role in etiology.

Diffusion tensor magnetic resonance imaging (DTI) is a neuroimaging technique that elucidates abnormalities of brain white matter (WM), based on structural investigation of a tissue via measurement of diffusion rate and direction of water molecules. This method lets imaging of white matter tracts, whole anatomical extent and structural integrity of the brain tissue. So, it can provide data about anatomical connectivity of brain. There are some parameters used for indicating microstructural integrity of white mat-ter such as fractional anisotropy (FA) and apparent diffusion coefficient (ADC) in DTI. FA is a measure which reflects directional coherence of water diffusion, and it is sen¬sitive to microstructural WM differences. It is defined on a scale ranging from mostly isotro¬pic (when approaching to zero) indicating poor integrity of the axons to mostly anisotropic (when approaching to 1) indicating intact WM integrity. ADC is a scalar index of the rate of water diffusion among different dif¬fusion directions under a Gaussian distribution. A higher value of ADC indicates lesser restricted diffusion, and it implies fewer organized structures in WM which supports presence of abnormalities in the structural in¬tegrity of white matter. As it has a complicated literature, in this study, we aimed to investigate neuronal integrity and its abnormalities by DTI, which may contribute to the etiology of bipolar depression.

Study Type

Observational

Enrollment (Actual)

32

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Sixteen subjects with bipolar type I disorder depressive episode diagnosed by SCID-I were recruited from Psychiatry Department of Harran University Research Hospital, and sixteen healthy control subjects were enrolled from the hospital staff. Patient and control groups have been matched by age and sex. A written informed consent was obtained from each volunteered participant.

Description

Inclusion Criteria:

Patients;

  • Aged between 18 and 65
  • Having a diagnosis of bipolar type I disorder depressive episode by Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I)
  • Having no other general medical, neurological or psychiatric condition Healthy controls;
  • Matched with bipolar depressive patients by age and sex
  • Having no other general medical, neurological and psychiatric condition

Exclusion Criteria:

  • Bipolar depressive patients and healthy control subjects with any other general medical, neurological or psychiatric condition, metal implant, severe head injury or pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Bipolar Depression
Subjects with bipolar type I disorder depressive episode diagnosed by Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I)
Healthy
Healthy control subjects matched with bipolar depressive patients by age and sex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain white matter abnormality
Time Frame: Within a day
The fractional anisotropy and appearent diffusion coefficient parameters of corpus callosum genu and corpus callosum splenium of both groups
Within a day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mustafa Çelik, MD, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

April 18, 2021

First Submitted That Met QC Criteria

April 18, 2021

First Posted (Actual)

April 22, 2021

Study Record Updates

Last Update Posted (Actual)

April 26, 2021

Last Update Submitted That Met QC Criteria

April 22, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 21012021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is no plan about sharing individual participant data with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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