Anxious-depressive
Conditions
Interventions
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.
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 accorda
Sponsors
Warakukai Incorporated Medical Institution
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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")
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Clinical Global Impression scale - Severity of illness 2 Clinical Global Impression scale - Global improvement 3Structured Clinical Interview of Anxious depressive attack | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactHaruna Irino
Warakukai Incorporated Medical Institution Akasaka Clinic
Outcome results
None listed