UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055058 |
|---|---|
| Receipt number | R000062896 |
| Scientific Title | Survey on the actual state of Augmentation Therapy with Atypical Antipsychotics in the Treatment of Depression -A study using a Japanese health insurance claims database - |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2024/07/24 10:45:57 |
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Basic information
Public title
Survey on the actual state of Augmentation Therapy with Atypical Antipsychotics in the Treatment of Depression
-A study using a Japanese health insurance claims database -
Acronym
Survey on the actual state of Augmentation Therapy with Atypical Antipsychotics in the Treatment of Depression
Scientific Title
Survey on the actual state of Augmentation Therapy with Atypical Antipsychotics in the Treatment of Depression
-A study using a Japanese health insurance claims database -
Scientific Title:Acronym
Survey on the actual state of Augmentation Therapy with Atypical Antipsychotics in the Treatment of Depression
Region
| Japan |
Condition
Condition
Major Depressive Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the actual state of atypical antipsychotic augmentation therapy in treatment of depression
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time from antidepressant prescription start date to initiation of atypical antipsychotic augmentation therapy
Line of treatment from antidepressant prescription start date to start of atypical antipsychotic augmentation therapy
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who had been diagnosed with depression at least once during the inclusion period and have a prescription for an antidepressant
2. Patients who were 18 years or older at the index date. The index date was the first day an antidepressant was prescribed after a new diagnosis of depression during the inclusion period
3. Patients who had been registered in the ledgers on insureds for more than one year before the new diagnosis of depression and for more than two and a half years after the index date
4. Patients who had a diagnosis of depression as described below in 1 or 2:
1) If the new diagnosis of depression was outpatient, there was at least one diagnosis of depression within one year after the index date
2) The new diagnosis of depression was diagnosed during hospitalization
Key exclusion criteria
Patients who met the following criteria within the year prior to the new diagnosis of depression were excluded.
1. Patients who had been diagnosed with schizophrenia, schizoaffective disorder, or delusional disorder
2. Patients who had a prescription for an antidepressant
3. Patients who had a prescription for an antipsychotic
4. Patients who had been diagnosed with bipolar disorder
5. Patients who had a prescription for a mood stabilizer
6. Patients who had a diagnosis of organic mental disorders, including symptomatic ones
7. Patients who had a diagnosis of mental and behavioral disorders due to the use of psychoactive substances
After the index date, cases that violate the following criteria will be excluded
1. There was no diagnosis of depression after the oldest month of treatment where the diagnosis was only bipolar disorder in the same patient ID + same treatment year and month
2. There was no diagnosis of depression after the oldest month of treatment where the diagnosis was only schizoaffective disorder and delusional disorder in the same patient ID + same treatment year and month
3. There was no diagnosis of depression after the oldest month of treatment where the diagnosis was only organic mental disorder in the same patient ID + same treatment year and month
4. Patients who had a prescription for Clozapine
5. Patients who had a prescription for long-acting injectable antipsychotics
Target sample size
76000
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Sekine |
Organization
Otsuka Pharmaceuticals Co., Ltd
Division name
Medical Affairs Department
Zip code
108-8242
Address
Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
TEL
03-6717-1400
sekined@otsuka.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Sekine |
Organization
Medical Affairs Department
Division name
Otsuka Pharmaceuticals Co., Ltd
Zip code
108-8242
Address
Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
TEL
03-6717-1400
Homepage URL
sekined@otsuka.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The research ethics committee of Otsuka Pharmaceutical Co., Ltd
Address
463-10 Kagasuno, Kawauchi-cho, Tokushima-city, Tokushima 771-0192, Japan
Tel
088-665-2126
Suzuki.Takashi@otsuka.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To clarify the actual state of atypical antipsychotic augmentation therapy in treatment of depression
Management information
Registered date
| 2024 | Year | 07 | Month | 24 | Day |
Last modified on
| 2024 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062896
