Dextromethorphan has been reported affording neuroprotection on dopaminergic neurons and having protective effect against inflammation-related neuron damage. These anti-inflammatory and neuroprotective effects of dextromethorphan would suggest potential clinical benefits of dextromethorphan add-on therapy to valproate for bipolar disorder patients. This hypothesis was based on the findings that the mood stabilizers have been reported to be neuroprotective through the release of neurotrophic factors such as GDNF from astroglia. Thus, the combination treatment of mood stabilizers and dextromethorphan might improve the therapeutic efficacy for bipolar disorder patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
VPA plus dextromethorphan 60 mg per day
VPA plus placebo
VPA \& Dextromethorphan 30 mg per day
Ru-Band Lu
Tainan, Taiwan
Young's Mania Rating Scale (YMRS)
The severity of current manic symptoms will be assessed by using the YMRS
Time frame: baseline, 1, 2, 4, 8 and 12 weeks
Hamilton Depression Rating Scale (HDRS)
The severity of depressive symptoms will be evaluated by HDRS
Time frame: baseline, 1, 2, 4, 8 and 12 weeks
blood samples
The immune markers, cytokines will be measured at each time point to follow each patient's changes.
Time frame: baseline, 1, 2, 4, 8 and 12 weeks
lipid profiles
Time frame: baseline, after treatment
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