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Combination of Dextromethorphan and Memantine in Treating Bipolar Disorder

NCT03039842 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2017-07-11

No results posted yet for this study

Summary

This is a research clinical trial of double-blind, stratified randomized, parallel group, two-centre study. It will be conducted in a total of 250\~300 male and female subjects from the Department of Psychiatry at National Cheng Kung University Hospital. Eligible subjects will be psychiatric out- and in-patients, aged between 18\~65 years old, who have psychiatric evaluation with clinically suspected of having bipolar II disorder and fulfill the inclusion and exclusion criteria. The add-on double-blind study treatment with dextromethorphan/place will commence at randomization for while patients continue open-label valproate. Subjects will be enrolled for 12 weeks double-blind add-on treatment and randomly assigned to (1) 30mg dextromethorphan+valproate, (2) 5mg memantine+valproate, (3) dextromethorphan+memantine+valproate or (4) placebo+valproate. Concomitant benzodiazepine medication (preferably up to 8mg lorazepam) may be used for daytime sedation, agitation or insomnia during the study. For the consideration of the less influence to immune-system, resperidone 1-3mg/daily and fluoxetine maximum 20mg/daily will be chose. We will measure the treatment response and side effect to clarify the curative effect of DM and memantine add-on therapy to valproate in the treatment of bipolar disorders. This study is being performed to investigate the possibly significant beneficial effects on the subtypes of bipolar disorders psychopathology.

Conditions

  • Bipolar Disorder II

Interventions

DRUG

Dextromethorphan

DRUG

Memantine

DRUG

dextromethorphan+memantine

DRUG

placebo+valproate

Sponsors & Collaborators

  • National Cheng-Kung University Hospital

    lead OTHER

Principal Investigators

  • Ru-Band Lu, MD · Department of Psychiatry, National Cheng Kung University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-01-01
Primary Completion
2016-12-31
Completion
2017-12-31

Countries

  • Taiwan

Study Locations

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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 NCT03039842 on ClinicalTrials.gov