Safety and Efficacy of MEM 1003 Versus Placebo for the Treatment of Patients With Bipolar I Disorder

Bipolar Disorder With Manic or Mixed Episodes Clinical Trial

Official title:

A Multicenter, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MEM 1003 for the Treatment of Patients With Bipolar I Disorder Suffering Acute Manic or Mixed Episodes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00374920
• Other study ID #: MEM 1003-101
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2006
• Last updated: May 5, 2008
• Start date: September 2006
• Est. completion date: March 2007

Study information

• Verified date: May 2008
• Source: Memory Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to establish the potential of MEM 1003 as a safe and effective treatment for patients with an acute manic or mixed episode of bipolar disorder.

Description:

Bipolar affective disorder is one of the most common, severe, and persistent mental illnesses. It is characterized by periods of deep, prolonged, and profound depressions that alternate with periods of excessively elevated and/or irritable mood (mania). The pathophysiology of bipolar disorder is complex, and can include an inheritable component, administration of antidepressant medications, behavioral sensitization processes, and neuronal calcium dysregulation that leads to apoptosis of critical brain circuitry that regulates emotion. Addressing the dysregulation in calcium levels in the central nervous system by administering compounds such as MEM 1003 may have the potential for altering the cyclical course or progression of bipolar disorder.

MEM 1003 is the (+)-enantiomer of a dihydropyridine that has been optimized for central nervous system activity. It inhibits L-type Ca2+ channels and within the anticipated human dosing range has more benign cardiovascular effects than other DHP L-Type calcium channel modulators.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• bipolar I disorder with acute manic or mixed episode, with or without psychotic features

• YMRS score of at least 20

• history of at least one previous manic or mixed episode requiring treatment in the last 10 years

Exclusion Criteria:

• history of failing to respond to treatment with two or more adequate trials of approved anti-manic medications for the current episode

• Axis I or Axis II disorder (other than bipolar I disorder) that requires treatment or has been the primary subject of treatment in the past 3 months

• defined substance abuse or dependency within the 3 months

• schizophrenia, schizoaffective disorder, delusional disorder, mental retardation or pervasive developmental disorder

• suicidal or danger to others

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar Disorder With Manic or Mixed Episodes

Intervention

Drug:
• MEM 1003

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Memory Pharmaceuticals	Stanley Medical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate at Day 21
Secondary	Change from baseline to Day 21 in other efficacy measures and safety