Anxious-depressive attack
Conditions
Interventions
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.
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'
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Clinical Global Impression scale - Severity of illness 2 Clinical Global Impression scale - Global improvement 3 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 SF-8 | — |
Countries
Japan
Contacts
Public ContactHisanobu Kaiya
Warakukai Incorporated Medical Institution Akasaka Clinic
Outcome results
None listed