NCT01188265

Add-on Dextromethorphan in Bipolar Disorders

Dextromethorphan Enhances the Therapeutic Efficacy of Valoproate in Bipolar Disorder Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: National Cheng-Kung University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	Valproate
DRUG	Dextromethorphan 60 mg per day	VPA plus dextromethorphan 60 mg per day
DRUG	Placebo	VPA plus placebo
DRUG	Dextromethorphan 30 mg	VPA \& Dextromethorphan 30 mg per day

Timeline

• Start date: 2007-06-01
• Primary completion: 2010-12-01
• Completion: 2011-06-01
• First posted: 2010-08-25
• Last updated: 2013-09-17

Locations

1 site across 1 country: Taiwan