A Phase 3 interventional study of Dextromethorphan and Memantine in Bipolar Disorder II, sponsored by National Cheng-Kung University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-07-11.
Sponsored by National Cheng-Kung University Hospital · Phase 3, Interventional, and Treatment
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.
A total of 250\~300 male and female subjects from the Department of Psychiatry at National Cheng Kung University Hospital. Eligible subjects who are aged between 18\~65 years old and clinically suspected of having bipolar II disorder are invited. 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.
1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.
This study's planned enrollment of 300 is above the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →National Cheng-Kung University Hospital is the lead sponsor of 268 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
30mg dextromethorphan+valproate
Drug: Dextromethorphan
5mg memantine+valproate
Drug: Memantine
dextromethorphan+memantine+ valproate
Drug: dextromethorphan+memantine
Placebo+valproate
Drug: placebo+valproate
Also known as: 30mg dextromethorphan
Also known as: 5mg memantine+valproate
treatment change assessed by plasma levels of cytokines (e.g., IL-6, IL-8)
change assessment
Time frame: baseline, week 1, week 2, week 4, week 8, week 12
depression change change
depression change assessed by Hamilton Depression Rating Scale
Time frame: baseline, week 1, week 2, week 4, week 8, week 12
manic state change
Manic symptom assessed by Young Mania Rating Scale
Time frame: baseline, week 1, week 2, week 4, week 8, week 12
attention function change
attention change assessed by CPT
Time frame: baseline, week 12
memory change
memory change assessed by WMS
Time frame: baseline, week 12
executive functioning change
executive function change assessed by WCST
Time frame: baseline, week 12
Plan to share: No
This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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National Cheng-Kung University Hospital