UMIN-CTR Clinical Trial

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

Anxious-depressive

Classification by specialty

Psychosomatic Internal Medicine	Psychiatry	Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Warakukai Incorporated Medical Institution

Institute

Department

Personal name

Organization

Warakukai Incorporated Medical Institution

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

03

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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

Registered date

2017

Year

07

Month

20

Day

Last modified on

2018

Year

07

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031740