UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized, double-blind, adjustable-dose, parallel-group study of mosapramine or aripiprazole for the treatment of Anxiety-Depressed Attack.
Title of the study (Brief title)	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	Hisanobu Kaiya
Organization	Warakukai Incorporated Medical Institution
Division name	a director
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	Haruna Irino
Organization	Warakukai Incorporated Medical Institution
Division name	Akasaka Clinic
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 08 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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