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Add-on Dextromethorphan in Bipolar Disorders

NCT01188265 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2013-09-17

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • National Health Research Institutes, Taiwan

    collaborator OTHER

  • TTY Biopharm

    collaborator INDUSTRY

  • National Cheng-Kung University Hospital

    lead OTHER

Principal Investigators

  • Ru-Band Lu, MD · National Cheng-Kung University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2010-12-31
Completion
2011-06-30

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01188265 on ClinicalTrials.gov