UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033291 |
|---|---|
| Receipt number | R000037953 |
| Scientific Title | A randomized, double-blind, adjustable-dose, parallel-group study of haloperidol or aripiprazole for the treatment of Anxiety-Depressed Attack |
| Date of disclosure of the study information | 2018/07/05 |
| Last modified on | 2022/11/10 18:11:36 |
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Basic information
Public title
A randomized, double-blind, adjustable-dose, parallel-group study of haloperidol or aripiprazole for the treatment of Anxiety-Depressed Attack
Acronym
A randomized, double-blind, parallel-group study of haloperidol or aripiprazole for the treatment of Anxiety-Depressed Attack
Scientific Title
A randomized, double-blind, adjustable-dose, parallel-group study of haloperidol or aripiprazole for the treatment of Anxiety-Depressed Attack
Scientific Title:Acronym
A randomized, double-blind, parallel-group study of haloperidol or aripiprazole for the treatment of Anxiety-Depressed Attack
Region
| Japan |
Condition
Condition
Anxious-depressive attack
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to identify the subtype of the dopamine receptor related with ADA
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1 Clinical Global Impression scale - Severity of illness
2 Clinical Global Impression scale - Global improvement
3 Anxious depressive attack
Key secondary outcomes
4 Anxious depression scale
5 The 16-Item Quick Inventory of Depressive Symptomatology (QIDS; self-report)
6 Interpersonal Sensitivity Measure(IPSM)
7 Hamilton Rating Scale for Depression(HAM-D)
8 Hamilton Anxiety Rating Scale Interview Guide(HARS-IG)
9 Cyberball Quesionnaire
10 Social Pain Questionnaire
11 Positive and Negative Affect Schedule(PANAS)
12 SF-8
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Haloperidol (100-1000mg / day) was administered orally, in devided powder, once a day at bedtime. Haloperidol was initiated at 100mg / day and administered in accordance with subject's health state.
Interventions/Control_2
Aripiprazole (100-1000mg/day) was administered orally, in devided powder, once a day at bedtime. Aripiprazole was initiated at 100mg/day and administered in accordance with subject's health state.
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
| 16 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients who met all the conditions below:
1) Experienced first ADA or ADA after over 3months of interval in 6months
2) Experienced ADA over two times in the past 2weeks
3) Admitted being capable of understanding and participating in this study by a doctor
4) Being capable of writing informed form by oneself
5) 20-50years old
6) Agreed to appropriate contraception during participating in this study
Key exclusion criteria
Patients were excluded if they met any one of follow conditions:
1 Patients in a coma or with circulatory collapse
2 Patients under strong influence of central nervous system depressant
3 Patients with severe heart failure
4 Patients with Parkinson's disease
5 Patients with hypersensitivity to haloperidol, butyrophenone compound, and/or aripiprazole
6 Patients while taking adrenaline
7 Patients in pregnancy or breastfeeding
8 Patients with hepatic dysfunction
9 Patients with cardiovascular disease, or hypotension
10 Patients who are likely to occur QT extension
11 Patients with spasmodic disorder such as epilepsia
12 Patients with overactive thyroid function
13 Patients in bad health with dehydrated, and/or malnutrition
14 Patients in high temperature environment
15 Patients have diabetes, have history of diabetes, have family history of diabetes, have elevated blood glucose, or have obesity-related risk factor
16 Patients with imminent risk of suicide or injury to self, others, or property, or patients with a score of >= 10 on the MINI item C (risk of suicide).
17 Patients meet criteria of DSM-5 schizophrenia or have history of schizophrenia
18 Patients have clinically significant neurological impairment
19 Patients have neurodegenerative disorder
20 Patients receiving any antiphychotics at visit1
21 Patients receiving psychotherapy at visit1 or will be introduced in psychotherapy during participating in this study
22 Patients with previous or existing clinically significant complications, such as serious nervous system, endocrine system, hepatic, renal, hematological, respiratory, cardiovascular, gastrointestinal, urological, or other diseases. Patients who have a history of any of such diseases and who are considered ineligible for the study by the investigator
23 Patients with a history or existing alcohol/drug abuse/dependence (DSM-5 criteria). Exceptions include mild caffeine or nicotine abuse/dependency
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hisanobu |
| Middle name | |
| Last name | Kaiya |
Organization
Warakukai Incorporated Medical Institution
Division name
a director
Zip code
0000000
Address
3-9- 18, BIC Akasaka Building 6F, Akasaka, Minato, Tokyo, Japan
TEL
03-5575-8198
kaiya-psim@umin.ac.jp
Public contact
Name of contact person
| 1st name | Hisanobu |
| Middle name | |
| Last name | Kaiya |
Organization
Warakukai Incorporated Medical Institution
Division name
Akasaka Clinic
Zip code
0000000
Address
3-9- 18, BIC Akasaka Building 6F, Akasaka, Minato, Tokyo, 107-0052 Japan
TEL
03-5575-8198
Homepage URL
kai@fuanclinic.com
Sponsor or person
Institute
Warakukai Incorporated Medical Institution
Institute
Department
Personal name
Funding Source
Organization
None
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
Warakukai Incorporated Medical Institution
Address
3-9- 18, BIC Akasaka Building 6F, Akasaka, Minato, Tokyo, Japan
Tel
0355758198
kai@fuanclinic.com
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
医療法人和楽会赤坂クリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 05 | 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
| 2018 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 05 | Day |
Last modified on
| 2022 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037953
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| Registered date | File name |
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