UMIN-CTR Clinical Trial

Basic information
Public title	Research on Predictors of Recovery in Mood Disorders
Acronym	PREP-MD study
Scientific Title	PREP-MD study: PRedictors of functional Recovery in Patients with Mood Disorder
Scientific Title:Acronym	PREP-MD study
Region	Japan

Condition
Condition	Major Depressive Disorder, Bipolar disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to identify predictors of functional recovery in mood disorders.
Basic objectives2	Others
Basic objectives -Others	In recent years, the number of mental health problems among workers has been on the rise, and the issues of absence from work and return to work associated with mental illness have been greatly highlighted. Mood disorders, mainly major depressive disorder and bipolar disorder, are mental disorders characterized by depressed mood and decreased interest and pleasure. The outcomes of mood disorders are known to vary among individuals, but the psychological, social, and biological factors that determine them are not clear. The purpose of this study is to explore the psychological, social, and biological factors that predict social recovery from mood disorders.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Psychological, social, and biological factors predicting functional recovery in mood disorders
Key secondary outcomes	Differences in social adjustment between the "recovery" and "non-recovery" groups on the Japanese version of the Self-Administered Social Adjustment Scale (SASS). Differences between the "recovery" and "non-recovery" groups in physician-administered objective depression ratings (HAM-D) and subjective depression ratings (BDI-II). Comparison of job titles between the "recovery" and "non-recovery" groups. Differences in social networks using the LSNS-6 between the "recovery" and "non-recovery" groups Differences in developmental disability-related scales (AQ-J, ASRS) between the "recovery" and "non-recovered" groups. Differences between the "recovery" and "non-recovered" groups on the UCLA Loneliness Scale (loneliness) Differences in self-esteem between the "recovery" and "non-recovery" groups. Differences in self-esteem between the "recovery" and "non-recovery" groups on the Lazarus Stress Coping Inventory of stress coping behaviors. Differences in the Mood and Fatigue Checklist between the "recovery" and "non-recovery" groups. Differences between the "recovery" and "non-recovery" groups in attention and memory using the THINC-it tablet cognitive function test. Difference in imipramine equivalents of antidepressants between the "recovery" and "non-recovery" groups Difference in diazepam equivalents of benzodiazepines between the "recovery" and "non-recovery" groups.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients undergoing outpatient treatment at the Department of Neuropsychiatry, The Jikei University School of Medicine or the Katsushika Medical Center, The Jikei University School of Medicine. Patients with a DSM-5 diagnosis of major depressive disorder or bipolar affective disorder Patients who have achieved functional recovery (defined as those who have a score of 7 or less on the 17-point version of the Hamilton Depression Rating Scale and have been working for at least 6 months at the time of the survey), or those who have not yet achieved functional recovery (those who do not meet the aforementioned criteria for functional recovery). Patients who are able to read and understand the notice regarding consent explanation.
Key exclusion criteria	Patients with psychiatric symptoms such as depressed mood, anxiety, agitation, elated mood, aggression, etc., who have poor judgment and have difficulty in participating in the study voluntarily. Patients who are found to be in a manic or hypomanic state by the attending physician or physician in charge. Patients who have been diagnosed with intellectual disability, substance-related disorder, or organic mental disorder. Patients who are judged as inappropriate by the attending physician or the physician in charge.
Target sample size	240

Research contact person
Name of lead principal investigator	1st name Junpei Middle name Last name Ishii
Organization	Jikei University School of Medicine
Division name	Department of Psychiatry
Zip code	105-8461
Address	3-25-8 Nishi-shinbashi, Minato-ku, Japan
TEL	03-3433-1111
Email	jishii@jikei.ac.jp

Public contact
Name of contact person	1st name Junpei Middle name Last name Ishii
Organization	Jikei University School of Medicine
Division name	Department of Psychiatry
Zip code	105-8461
Address	3-25-8 Nishi-shinbashi, Minato-ku, Japan
TEL	03-3433-1111
Homepage URL
Email	jishii@jikei.ac.jp

Sponsor
Institute	Jikei University School of Medicine Department of Psychiatry
Institute
Department

Funding Source
Organization	Jikei University School of Medicine Department of Psychiatry
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee of Jikei University School of Medicine
Address	3-25-8 Nishi-shinbashi, Minato-ku, Japan
Tel	03-3433-1111
Email	crb@jikei.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東京慈恵会医科大学附属病院

Other administrative information
Date of disclosure of the study information	2021 Year 07 Month 20 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2021 Year 06 Month 21 Day
Date of IRB	2021 Year 06 Month 21 Day
Anticipated trial start date	2021 Year 06 Month 21 Day
Last follow-up date	2023 Year 01 Month 31 Day
Date of closure to data entry	2023 Year 04 Month 30 Day
Date trial data considered complete	2023 Year 04 Month 30 Day
Date analysis concluded	2023 Year 04 Month 30 Day

Other
Other related information	NA

Management information
Registered date	2021 Year 07 Month 09 Day
Last modified on	2021 Year 07 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051184