Series Studies of Bipolar Disorder-Valproate add-on Memantine

NCT01188148 | Completed Phase 2 DMC

• 1 other identifier: BPMM HR-98-025
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

Brief Summary

All participants should fulfill the following criteria: aged between 18 and 65 years old, and of domestic Han descendants. Participants will be randomly assigned to either the (1) pharmacotherapy (valproate add-on memantine) group; (2) pharmacotherapy (valproate add-on memantine) plus Cognitive Behavior Group Therapy (CBGT) group; (3) valproate add-on placebo plus CBGT group, or (4) valproate add-on placebo only group. A total of 240-320 individuals (60-80 participants per group) will be recruited for this study. For each CBGT group, 12-weekly sessions are scheduled according to patients' preference. The investigators will attempt to understand the effects of pharmaceutical drugs for mood stabilizers add-on neuro-protective drugs, pharmacotherapy with CBGT, mood stabilizer with CBGT, and the use of only traditional mood stabilizers in the treatment of BP II. Comparisons will be made for each type of treatment and possible mechanisms will be examined regarding the pharmacotherapy and CBGT for bipolar disorder patients.

Conditions

Bipolar Disorders

Outcome Measures

Primary Outcomes (2)

• Young's Mania Rating Scale (YMRS)

  Normally, YMRS is used to evaluate the Bipolar Disorder Patient's mood change.

  baseline, 1, 2, 4, 8 and 12 weeks

• Hamilton Depression Rating Scale (HDRS)

  Normally, YMRS is used to evaluate the Bipolar Disorder Patient's mood change of depression.

  baseline, 1, 2, 4, 8 and 12 weeks

Secondary Outcomes (3)

• cytokines

  baseline, 1, 2, 4, 8 and 12 weeks

• Clinical Global Impression (CGI)

  baseline, 1, 2, 4, 8 and the week 12

• lipid profiles

  baseline, 1, 2, 4, 8 and 12 weeks

Other Outcomes (1)

• genetics

  baseline

Study Arms (2)

VPA & Placebo

ACTIVE COMPARATOR

VPA \& Placebo

Drug: Placebo

VPA & memantine

EXPERIMENTAL

Drug: Memantine

Interventions

Memantine DRUG

5 mg per day of memantine

VPA & memantine

Placebo DRUG

VPA & Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patient aged \>=18 and \<= 65 years.
• A diagnosis of bipolar II disorder according to DSM-IV-TR criteria made by a specialist in psychiatry.
• A total of HDRS score at least 18 or YMRS score at least 14 at screen.
• Signed informed consent by patient or legal representative.

You may not qualify if:

• Women of childbearing potential not using adequate contraception as per investigator judgment or not willing to comply with contraception for duration of study.
• Females who are pregnant or nursing.
• Patient has received memantine or other selective cyclo-oxygenase 2 (Cox-2) inhibitors within 1 week prior to first dose of double-blind medication.
• Axis-I DSM-IV-TR diagnosis other than bipolar II disorder.
• 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.
• History of intolerance to valproate or memantine or other Cox-2 inhibitors.
• History of sensitivity reaction (e.g., urticaria, angioedema, bronchospasm, severe rhinitis, anaphylactic shock) precipitated by memantine
• Patient has received electroconvulsive therapy (ECT) within 4 weeks prior to first dose of doubleblind medication.
• Increase in total SGOT, SGPT, BUN and creatinine by more than 3X ULN (upper limit of normal).
• 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.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Ru-Band Lu

Tainan, 704, Taiwan

Location

Related Publications (3)

• 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.

  PMID: 24103632 DERIVED

• 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.

  PMID: 23870798 DERIVED

• 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.

  PMID: 23826157 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Memantine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Ru-Band Lu, MD

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2010
• First Posted: August 25, 2010
• Study Start: August 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: September 17, 2013

Record last verified: 2009-08

Locations

TW (1)