Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Otsuka Pharmaceutical Development & Commercialization, Inc.
With
Otsuka Pharmaceutical Co., Ltd.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Have a diagnosis of a single or recurrent, nonpsychotic episode of MDD as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by both the Mini International Neuropsychiatric Interview (M.I.N.I.) and an adequate clinical psychiatric evaluation.
Have a treatment history of an inadequate ADT response to at least 1 ADT (but not \> 3) for the current episode.
Have received a single, trial-approved, SSRI or SNRI at an adequate dose for
≥ 6 weeks prior to screening.
Are 18 to 65 years old at the time of consent (inclusive, and outpatients only).
Have a Hamilton Depression Rating Scale (HAM-D)-17-item Total Score ≥ 18 at screening and baseline.
Have a Hamilton Anxiety Rating Scale (HAM-A) Total Score ≥ 20 at screening and baseline.
You may not be if
Subjects with any of the following current Axis I DSM-IV-TR diagnoses:
delirium
dementia
amnestic
other cognitive disorders
schizophrenia
schizoaffective disorder
other psychotic disorders
bipolar I disorder,
bipolar II disorder
bipolar disorder not otherwise specified (NOS)
eating disorders
anorexia nervosa
bulimia
obsessive compulsive disorder
post-traumatic stress disorder
Subjects with any of the following current Axis II DSM-IV-TR diagnoses:
