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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000028305
Receipt No. R000031740
Scientific Title A randomized, double-blind, adjustable-dose, parallel-group study of mosapramine or aripiprazole for the treatment of Anxiety-Depressed Attack.
Date of disclosure of the study information 2019/03/31
Last modified on 2018/07/05

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Basic information
Public title A randomized, double-blind, adjustable-dose, parallel-group study of mosapramine or aripiprazole for the treatment of Anxiety-Depressed Attack.
Acronym A randomized, double-blind, parallel-group study of mosapramine or aripiprazole for the treatment of Anxiety-Depressed Attack.
Scientific Title A randomized, double-blind, adjustable-dose, parallel-group study of mosapramine or aripiprazole for the treatment of Anxiety-Depressed Attack.
Scientific Title:Acronym A randomized, double-blind, parallel-group study of mosapramine or aripiprazole for the treatment of Anxiety-Depressed Attack.
Region
Japan

Condition
Condition Anxious-depressive
Classification by specialty
Psychosomatic Internal Medicine Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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 Structured Clinical Interview of 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 Tokyo University Egogram New Ver.II

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 Mosapramine (in range of 200 to 1000mg / day) was administered orally, in devided powder, once a day at bedtime. Mosapramine was initiated at 200mg / day and administered in accordance with subject's health state.
Interventions/Control_2 Aripiprazole (in range of 200 to 1000mg / day) was administered orally, in devided powder, once a day at bedtime. Aripiprazole was initiated at 200mg / 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 while taking adrenaline
4 Patients with Parkinson's disease
5 Patients with hypersensitivity to mosapramine, aripiprazole, and/or iminodibenzyl based compound
6 Patients in pregnancy or breastfeeding
7 Patients with hepatic dysfunction
8 Patients with cardiovascular disease, or hypotension
9 Patients with hematological diseases
10 Patients with spasmodic disorder such as epilepsia
11 Patients with overactive thyroid function
12 Patients in bad health with dehydrated, and/or malnutrition
13 Patients have diabetes, have history of diabetes, have family history of diabetes, have elevated blood glucose, or have obesity related risk factor
14 Patients with organic brain deficit
15 Patients with comorbidity bring on high impulsivity
16 Patients meet criteria of DSM5 schizophrenia or have history of schizophrenia
17 Patients have clinically significant neurological impairment
18 Patients have neurodegenerative disorder
19 Patients receiving any antiphychotics at visit1
20 Patients receiving psychotherapy at visit1 or will be introduced in psychotherapy during participating in this study
21 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).
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
(continue to "other related information")
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisanobu Kaiya
Organization Warakukai Incorporated Medical Institution
Division name a director
Zip code
Address 3-9- 18, BIC Akasaka Building 6F, Akasaka, Minato, Tokyo, Japan
TEL 03-5575-8198
Email kaiya-psim@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Haruna Irino
Organization Warakukai Incorporated Medical Institution
Division name Akasaka Clinic
Zip code
Address 3-9- 18, BIC Akasaka Building 6F, Akasaka, Minato, Tokyo, 107-0052 Japan
TEL 03-5575-8198
Homepage URL
Email haruna.ts@gmail.com

Sponsor
Institute Warakukai Incorporated Medical Institution
Institute
Department

Funding Source
Organization Warakukai Incorporated Medical Institution
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2019 Year 03 Month 31 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 Terminated
Date of protocol fixation
2017 Year 08 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Excluded criteria (continued)


23 Patients with a history or existing alcohol/drug abuse/dependence (DSM-5 criteria). Exceptions include mild caffeine or nicotine abuse/dependency
24 Patients with a history of hypersensitivity to drug
25 Patients with a previous or existing malignant tumor (excluding appropriately treated basal cell carcinoma of the skin, squamous cell carcinoma, and uterine cervix cancer)
26 Patients with a history of HIV seropositivity, or patients with HBV/HCV infection and develop hepatitis
27 Patients with a previous or existing water intoxication
28 Patients who receive hormone treatment for gynecological disorder
29 Patients who received electroconvulsive therapy, vagal nerve stimulation, or repetitive transcranial magnetic stimulation within 180 days prior to screening, or will receive these therapy during participating in this study
30 Patients have impairment of cognitive function
31 Patients who are currently participating or prepared in a clinical trial study with an investigational or marketed compound or device within 3 months prior to visit 1
32 Patients who are otherwise considered ineligible for the study by the investigator

Management information
Registered date
2017 Year 07 Month 20 Day
Last modified on
2018 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031740

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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