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Series Studies of Bipolar Disorder-Valproate add-on Memantine (MM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01188148
Recruitment Status : Completed
First Posted : August 25, 2010
Last Update Posted : September 17, 2013
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Cheng-Kung University Hospital

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

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Study Type : Interventional  (Clinical Trial)
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 : August 2009
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

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




Primary Outcome Measures :
  1. Young's Mania Rating Scale (YMRS) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: baseline, 1, 2, 4, 8 and 12 weeks ]
  2. Clinical Global Impression (CGI) [ Time Frame: 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 [ Time Frame: baseline, 1, 2, 4, 8 and 12 weeks ]
    HDL, LDL, cholesterol and etc.


Other Outcome Measures:
  1. genetics [ Time Frame: baseline ]
    ALDH2, ADH1B, COMT, DRD2, DRD3, BDNFVal66Met



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01188148


Locations
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Taiwan
Ru-Band Lu
Tainan, Taiwan, 704
Sponsors and Collaborators
National Cheng-Kung University Hospital
National Science Council, Taiwan
Investigators
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Principal Investigator: Ru-Band Lu, MD National Cheng-Kung University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT01188148    
Other Study ID Numbers: BPMM HR-98-025
First Posted: August 25, 2010    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: August 2009
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Valproic Acid
Memantine
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Anticonvulsants
Enzyme Inhibitors
GABA Agents
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs