This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

An Evaluation of the Safety and Efficacy of Memantine in Patients With Acute Mania Associated With Bipolar I Disorder

This study has been completed.
Information provided by:
Forest Laboratories Identifier:
First received: March 24, 2005
Last updated: March 1, 2012
Last verified: March 2012
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 Intervention Phase
Bipolar Disorder Drug: Memantine HCl Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Evaluation of the Safety and Efficacy of Memantine in Patients With Acute Mania Associated With Bipolar I Disorder

Resource links provided by NLM:

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • 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

Enrollment: 35
Study Start Date: February 2005
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00106405

United States, California
Synergy Clinical Research Center
National City, California, United States, 91950
United States, Maryland
Sheppard Pratt Health System
Baltimore, Maryland, United States, 21204
United States, Missouri
St. Charles Psychiatric Associates
St. Charles, Missouri, United States, 63301
United States, Ohio
Psychiatric Professional Services, Inc.
Cincinatti, Ohio, United States, 45267-0559
United States, Texas
Rebecca Sealy Hospital
Galveston, Texas, United States, 77555-0197
University Hills Clinical Research
Irving, Texas, United States, 75062
Sponsors and Collaborators
Forest Laboratories
  More Information Identifier: NCT00106405     History of Changes
Other Study ID Numbers: MEM-MD-27
Study First Received: March 24, 2005
Last Updated: March 1, 2012

Keywords provided by Forest Laboratories:
Bipolar I Disorder
Memantine HCl

Additional relevant MeSH terms:
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
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 processed this record on August 16, 2017