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Completed

NCT Number: NCT01188148

Series Studies of Bipolar Disorder-Valproate add-on Memantine

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ru-Band Lu

Tainan, 704, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • Inclusion in another bipolar disorder study or study for another indication with psychotropic's within the last 30 days prior to start of study.
  • 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.

Treatment and study plan

Memantine

Drug

5 mg per day of memantine

Placebo

Drug

Primary outcomes

  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 outcomes

  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 outcomes

  1. genetics

    Time frame: baseline

    ALDH2, ADH1B, COMT, DRD2, DRD3, BDNFVal66Met

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Collaborators

  • National Science and Technology Council, Taiwan

Registry information

Official study title

Series Studies of Bipolar Disorder-Valproate add-on Memantine Treatment

Acronym: MM

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 25, 2010
Registry last updated
Sep 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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