UMIN-CTR Clinical Trial

Public title

Family Association and Reliable Predicting Factors for Treatment-Resistant Depression: A 10-Month Follow-Up Study

Acronym

FARPFTRD: A 10-Month FUS

Scientific Title

Family Association and Reliable Predicting Factors for Treatment-Resistant Depression: A 10-Month Follow-Up Study

Scientific Title:Acronym

FARPFTRD: A 10-Month FUS

Region

Asia(except Japan)

Condition

By collecting clinical and physiological data (including inflammation factors, EEG and brain resting functional MRI) from the family members of TRD and non-TRD cases, we aim to find reliable predictors of treatment-resistant depression (TRD) to facilitate accurate diagnosis and treatment planning for TRD patients.

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In the present study targeting TRD, Taiwan-based epidemiological study on treatment-resistant depression (TESTRD), we aim to investigate 200 patients with TRD and their first-degree relatives (FDR), including parents, siblings, and children, of the TRD.

Basic objectives2

Others

Basic objectives -Others

We will collect demographic and clinical data through MINI semi-structured interviews to assess psychiatric comorbidities. Additionally, we will measure inflammatory markers (e.g., soluble IL-2 receptor, soluble TNF-receptors, soluble P-selectin) in the blood, as these markers are often elevated in MDD patients. Our study aims to identify reliable predictors for TRD and examine the prevalence of psychiatric comorbidities, particularly TRD, in first-degree relatives (FDR) of TRD patients. Given that TRD is associated with a higher risk of developing bipolar disorder and dementia, as indicated by Taiwan's nationwide insurance data, we will follow MDD patients (TRD and non-TRD) and their family members every 5 months. Additionally, we will collect EEG and MRI data to explore brain signal predictors for TRD, focusing on PFC-related regions and the executive network.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Identify the variables that are most predictive of the participants' total MSM and TRDSS score.

Key secondary outcomes

1.TRD patients vs. non-TRD patients: have more family members with psychiatric comorbidities, especially TRD.
2.TRD patients vs. non-TRD patients: worse clinical outcomes during follow-up
3.TRD patients vs. non-TRD patients vs. family members: more likely to develop bipolar symptoms and dementia symptoms during follow-up
4.Identify good clinical predictors for MSM and TRDSS.
5.Identify good prediction models using EEG and MRI for MDD and TRD.
We would like to develop a new prediction model based on the results from our study.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

21

years-old

<=

Age-upper limit

70

years-old

>=

Gender

Male and Female

Key inclusion criteria

Patients are eligible for the study if they are adults (aged between 21 and 70 years) and are diagnosed with MDD based on the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. MDD diagnoses are established after a thorough medical history is taken and the semi-structured Mini International Neuropsychiatric Interview (American Psychiatric Association, 1994) is conducted. Patients' FDR, including parents, siblings, and children, will be interviewed for psychiatric comorbidities.

Key exclusion criteria

Patients are excluded if they have a lifetime psychiatric history of psychotic disorders, bipolar disorder, or organic mental disorder, or if they have a lifetime medical history of major systemic illness or neurological disorder (e.g., stroke, seizure, traumatic brain injury, or post-brain surgery).

Target sample size

200

Name of lead principal investigator

1st name	Cheng-Ta
Middle name
Last name	Li

Organization

Taipei Veterans General Hospital, Taipei, Taiwan

Division name

Department of Psychiatry

Zip code

112

Address

No.201, Sec. 2, Shih-Pai Road, Beitou district, Taipei, Taiwan

TEL

88628757027

Email

on5083@msn.com

Name of contact person

1st name	Jia-Shyun
Middle name
Last name	Jeng

Organization

Taipei Veterans General Hospital, Taipei, Taiwan

Division name

Department of Psychiatry

Zip code

112

Address

No.201, Sec. 2, Shih-Pai Road, Beitou district, Taipei, Taiwan

TEL

88628757027

Homepage URL

Email

arieljeng@gmail.com

Institute

Taipei Veterans General Hospital, Taipei, Taiwan

Institute

Department

Personal name

Organization

Taipei Veterans General Hospital, Taipei, Taiwan

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Institutional Review Board, Taipei Veterans General Hospital, Taipei, Taiwan

Address

NO.201, SEC. 2, SHIPAI RD, Taipei City, Taiwan

Tel

886-2-2875-7384

Email

irbopinion@vghtpe.gov.tw

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

08

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Enrolling by invitation

Date of protocol fixation

2022

Year

09

Month

01

Day

Date of IRB

2022

Year

08

Month

20

Day

Anticipated trial start date

2022

Year

09

Month

01

Day

Last follow-up date

2025

Year

08

Month

19

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Reliable predictors for treatment-resistant depression (TRD) are still warranted, and an increasing body of evidence indicates that TRD may be genetically determined. Therefore, the current Taiwan-based epidemiological study of TRD (TESTRD) aims to identify the optimal clinical and brain predictors of TRD in a 10-month follow-up design. We will also follow first-degree relatives (FDR) of TRD to determine whether the prevalence of psychiatric comorbidities, especially TRD, is higher in FDR of TRD. We aim to recruit 200 patients with major depressive disorder (MDD), including non-TRD and TRD (i.e., failed to respond to at least 2 adequate antidepressant trials), and 100 FDRs with MDD patients. Demographic data, clinical characteristics, psychiatric comorbidities, symptom ratings (e.g., objective and subjective depression and life stress) will be evaluated at baseline, and we will also follow them at 5 months and 10 months for additional clinical outcome measures. All the patients and 100 unaffected siblings will be further evaluated for their EEG and MRI. We hypothesize that FDR in the TRD family will have more psychiatric comorbidities, especially TRD, than FDR in the non-TRD family. We also hypothesize that TRD patients will have worse clinical outcomes than non-TRD patients, including a higher ratio of developing bipolar disorders and dementia. We also aim to find good predicting models for TRD by their prefrontal-related brain signals.

Registered date

2024

Year

08

Month

25

Day

Last modified on

2024

Year

08

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063232