Bipolar disorder affects 2.4 million adults in the USA between the ages of 18-65 and has considerable economic impact on our society. Bipolar mania accounts for 1 in 7 psychiatric emergencies and is associated with significant morbidity and mortality. The purpose of the study is to evaluate the safety and efficacy of open-label memantine in the acute management of adults with bipolar I disorder hospitalized for mania.

Condition	Treatment or Intervention	Phase
Bipolar Disorder	Drug: Memantine HCl	Phase II

Further Study Details: 

Primary Outcomes: Young Mania Rating Scale (YMRS); Mania Rating Scale; Clinical Global Impression; Montgomery Asberg Depression Rating Scale; Positive and Negative Syndrome Scale (PANSS); PANSS - Excited Component
Expected Total Enrollment:  36

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patients must have a documented clinical diagnosis of bipolar I disorder and must be currently experiencing a manic or mixed episode.
• Patients must be voluntarily hospitalized with a primary diagnosis of mania.

Exclusion Criteria:

• Rapid cycling bipolar disorder.
• Suicidal risk.
• First manic episode.
• ECT, clozapine or a depot neuroleptic in the past 3 months.
• Substance dependence.
• Known HIV infection.
• Co-morbid serious, uncontrolled systemic illness.

California
      Synergy Clinical Research Center, National City,  California,  91950,  United States; Recruiting
Maryland
      Sheppard Pratt Health System, Baltimore,  Maryland,  21204,  United States; Recruiting
Missouri
      St. Charles Psychiatric Associates, St. Charles,  Missouri,  63301,  United States; Recruiting
Ohio
      Psychiatric Professional Services, Inc., Cincinatti,  Ohio,  45267-0559,  United States; Recruiting
Texas
      University Hills Clinical Research, Irving,  Texas,  75062,  United States; Recruiting
      Rebecca Sealy Hospital, Galveston,  Texas,  77555-0197,  United States; Recruiting

Study ID Numbers:  MEM-MD-27
Record last reviewed:  April 2005
Last Updated:  April 7, 2005
Record first received:  March 24, 2005
ClinicalTrials.gov Identifier:  NCT00106405
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08