Bipolar I Disorder, Most Recent Episode DepressedNCT04855409
Neuronal Integrity in Bipolar Depression
An observational study of Bipolar I Disorder, Most Recent Episode Depressed, run by Mehmet Diyaddin Güleken.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar I Disorder, Most Recent Episode Depressed
- Type of treatment
- Injection or infusion
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Bipolar depressive patients and healthy control subjects with any other general medical, neurological or psychiatric condition, metal implant, severe head injury or pregnancy
About this study
Official title: 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
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Brain white matter abnormality
The fractional anisotropy and appearent diffusion coefficient parameters of corpus callosum genu and corpus callosum splenium of both groups
Measured: Within a day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study startApr 2011
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar I Disorder, Most Recent Episode DepressedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mehmet Diyaddin Güleken
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mehmet Diyaddin Güleken, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Investigators
- Mustafa Çelik, MD, Principal investigator, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855409
- Sponsor's protocol ID
- 21012021
- Status last verified
- Apr 2021
- First submitted
- 18 Apr 2021
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan about sharing individual participant data with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuronal Integrity and Suicidality in Bipolar Depression: a Diffusion Tensor Imaging Study
- ClinicalTrials.gov ID
- NCT04855409
- Acronym / sponsor ID
- 21012021
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mehmet Diyaddin GülekenUniversity, hospital or other
- Study start
- Apr 2011 (actual)
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Bipolar depressive patients and healthy control subjects with any other general medical, neurological or psychiatric condition, metal implant, severe head injury or pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Individual participant dataSharing planned: No. There is no plan about sharing individual participant data with other researchers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mustafa Çelik, MD principal investigator
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar I Disorder, Most Recent Episode Depressed, run by Mehmet Diyaddin Güleken.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain white matter abnormality (time frame: Within a day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.