Treatment-resistant Depression
Conditions
Interventions
None listed
Sponsors
National Center of Neurology and Psychiatry, Musashi Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: This study should be conducted in voluntary inpatients who meet DSM-IV-TR criteria for major depression and are resistant to conventional antidepressant pharmacotherapy. Treatment resistance is defined by history of failure to respond to antidepressants of more than two different classes, one of which should be TCA, after at least 4 weeks of therapy at an acceptable therapeutic dose. Written informed consent should be obtained voluntarily from all participants after the purpose, the methods and means, the effects, and the inconveniences and hazards have been fully explained.
Exclusion criteria
Exclusion criteria: Patients should be free of an experience of lithium augmentation during this episode. Other exclusion criteria are: present or previous history of brain infarction; present history of severe unstable physical illness including thyroidal dysfunction and glaucoma; hypersensitivity of lithium; fertile and sexually active women not on contraceptives; present use of epinephrine; high risk of suicide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| After the augmentation therapy, the patients will be divided into responders (a 50% or greater decrease in HAM-D scores between before and after treatment) and non-responders (less than 50%). The predictors (the differences between responders and non-responders) will be analyzed using mental and physical assessments including brain imaging before the therapy. | — |
Countries
Japan
Contacts
Public ContactMayumi Sato
National Center of Neurology and Psychiatry, Musashi Hospital Department of Psychiatry
Outcome results
None listed