Series Studies of Bipolar Disorder-Valproate add-on Memantine
NCT ID: NCT01188148
Last Updated: 2013-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
219 participants
INTERVENTIONAL
2009-08-31
2012-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
VPA & Placebo
VPA \& Placebo
Placebo
VPA & memantine
Memantine
5 mg per day of memantine
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Memantine
5 mg per day of memantine
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. A diagnosis of bipolar II disorder according to DSM-IV-TR criteria made by a specialist in psychiatry.
3. A total of HDRS score at least 18 or YMRS score at least 14 at screen.
4. Signed informed consent by patient or legal representative.
Exclusion Criteria
2. Females who are pregnant or nursing.
3. Patient has received memantine or other selective cyclo-oxygenase 2 (Cox-2) inhibitors within 1 week prior to first dose of double-blind medication.
4. Axis-I DSM-IV-TR diagnosis other than bipolar II disorder.
5. Current evidence of an uncontrolled and/or clinically significant medical condition (e.g., cardiac, hepatic and renal failure), which in the judgments of the investigator, would compromise patient safety or preclude study participation.
6. History of intolerance to valproate or memantine or other Cox-2 inhibitors.
7. History of sensitivity reaction (e.g., urticaria, angioedema, bronchospasm, severe rhinitis, anaphylactic shock) precipitated by memantine
8. Patient has received electroconvulsive therapy (ECT) within 4 weeks prior to first dose of doubleblind medication.
9. Inclusion in another bipolar disorder study or study for another indication with psychotropic's within the last 30 days prior to start of study.
10. Increase in total SGOT, SGPT, BUN and creatinine by more than 3X ULN (upper limit of normal).
11. Substance-related disorders within 6 months prior to study start, borderline personality disorder, schizophrenia, or other major psychiatric disorders as defined by DSM-IV criteria.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Science and Technology Council, Taiwan
OTHER_GOV
National Cheng-Kung University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ru-Band Lu, MD
Role: PRINCIPAL_INVESTIGATOR
National Cheng-Kung University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ru-Band Lu
Tainan City, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Lee SY, Chen SL, Chang YH, Chen SH, Chu CH, Huang SY, Tzeng NS, Wang CL, Wang LJ, Lee IH, Yeh TL, Yang YK, Hong JS, Lu RB. Genotype variant associated with add-on memantine in bipolar II disorder. Int J Neuropsychopharmacol. 2014 Feb;17(2):189-97. doi: 10.1017/S1461145713000825. Epub 2013 Oct 9.
Lee SY, Chen SL, Chang YH, Chen PS, Huang SY, Tzeng NS, Wang YS, Wang LJ, Lee IH, Yeh TL, Yang YK, Lu RB, Hong JS. Add-on memantine to valproate treatment increased HDL-C in bipolar II disorder. J Psychiatr Res. 2013 Oct;47(10):1343-8. doi: 10.1016/j.jpsychires.2013.06.017. Epub 2013 Jul 18.
Lee SY, Chen SL, Chang YH, Chen PS, Huang SY, Tzeng NS, Wang YS, Wang LJ, Lee IH, Wang TY, Yeh TL, Yang YK, Hong JS, Lu RB. Inflammation's Association with Metabolic Profiles before and after a Twelve-Week Clinical Trial in Drug-Naive Patients with Bipolar II Disorder. PLoS One. 2013 Jun 27;8(6):e66847. doi: 10.1371/journal.pone.0066847. Print 2013.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BPMM HR-98-025
Identifier Type: -
Identifier Source: org_study_id