Prediction of lithium carbonate response in treatment-resistant depression using brain imaging

UMIN ID: UMIN000001043

Registered date:01/03/2008

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Treatment-resistant Depression
• Date of first enrollment: 2008/03/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 69years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: National Center of Neurology and Psychiatry, Musashi Hospital
• Source(s) of Monetary Support: The Grant-in-Aid for Psychiatric and Neurological Diseases and Mental Health from the Ministry of Health, Labour and Welfare