Alcohol dependent
Conditions
Sponsors
Otsuka Pharmaceutical Co., Ltd.
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Japanese males and females aged 20 or above who have signed the informed consent form. - The patient has alcohol dependence, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-4-TR) and confirmed by Mini-international Neuropsychiatric Interview (M.I.N.I.).
Exclusion criteria
Exclusion criteria: - The patient with a current diagnosis or history of substance use disorders (except for alcohol, nicotine, and caffeine), according to DSM-4-TR and confirmed by M.I.N.I.. - The patient has reported current use of, or has tested positive for, drugs of abuse (opiates, methadone, cocaine, amphetamines, barbiturates) at the screening test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy The number of Heavy Drinking Days (HDDs) Change in the number of HDDs from baseline at Week 12 of the treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Total alcohol consumption (TAC) Change in TAC from baseline at Week 12 of the treatment period | — |
Countries
Japan
Outcome results
None listed