UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044818 |
|---|---|
| Receipt number | R000051184 |
| Scientific Title | PREP-MD study: PRedictors of functional Recovery in Patients with Mood Disorder |
| Date of disclosure of the study information | 2021/07/20 |
| Last modified on | 2021/07/09 17:27:41 |
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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
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
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
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
jishii@jikei.ac.jp
Sponsor or person
Institute
Jikei University School of Medicine
Department of Psychiatry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051184
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