MM: Series Studies of Bipolar Disorder-Valproate add-on Memantine

• Sponsor: National Cheng-Kung University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01188148
• Collaborator: National Science Council, Taiwan (Other)
• Enrollment: 219
• Location: 1
• Arms: 2
• Duration (Months): 38
• Patients Per Site Per Month: 5.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorders	Drug: Memantine; Drug: Placebo	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 219 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Series Studies of Bipolar Disorder-Valproate add-on Memantine Treatment
• Study Start Date: Aug 1, 2009
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: VPA & Placebo VPA & Placebo	Drug: Placebo
Experimental: VPA & memantine	Drug: Memantine; 5 mg per day of memantine

Outcome Measures

Primary Outcome Measures

1. Young's Mania Rating Scale (YMRS) [baseline, 1, 2, 4, 8 and 12 weeks]

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

2. Hamilton Depression Rating Scale (HDRS) [baseline, 1, 2, 4, 8 and 12 weeks]

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

Secondary Outcome Measures

1. cytokines [baseline, 1, 2, 4, 8 and 12 weeks]

2. Clinical Global Impression (CGI) [baseline, 1, 2, 4, 8 and the week 12]

   CGI will be used to evaluate how the patient's adverse effect go on during the trial.

3. lipid profiles [baseline, 1, 2, 4, 8 and 12 weeks]

   HDL, LDL, cholesterol and etc.

Other Outcome Measures

1. genetics [baseline]

   ALDH2, ADH1B, COMT, DRD2, DRD3, BDNFVal66Met

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male or female patient aged >=18 and <= 65 years.

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:

1. Women of childbearing potential not using adequate contraception as per investigator judgment or not willing to comply with contraception for duration of study.

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ru-Band Lu	Tainan		Taiwan	704

Sponsors and Collaborators

• National Cheng-Kung University Hospital
• National Science Council, Taiwan

Investigators

• Principal Investigator: Ru-Band Lu, MD, National Cheng-Kung University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Cheng-Kung University Hospital
• ClinicalTrials.gov Identifier: NCT01188148
• Other Study ID Numbers: BPMM HR-98-025
• First Posted: Aug 25, 2010
• Last Update Posted: Sep 17, 2013
• Last Verified: Aug 1, 2009

• Additional relevant MeSH terms: Bipolar Disorder; Memantine

Study Results

No Results Posted as of Sep 17, 2013