Clinical trial NCT00374920: Safety and Efficacy of MEM 1003 Versus Placebo for the Treatment of Patients With Bipolar I Disorder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bipolar Disorder With Manic or Mixed Episodes
Keywords: bipolar
mania
mixed
Lead sponsor: Memory Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Stanley Medical Research Institute
First posted: 2006-09-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Response rate at Day 21
Secondary outcomes:
measure: Change from baseline to Day 21 in other efficacy measures and safety
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Garden Grove
country: United States
state: California
city: Riverside
country: United States
state: California
city: San Diego
country: United States
state: California
city: Torrance
country: United States
state: California
city: Bradenton
country: United States
state: Florida
city: Ft Lauderdale
country: United States
state: Florida
city: Lake Charles
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Willingboro
country: United States
state: New Jersey
city: Philadelphia
country: United States
state: Pennsylvania
city: Austin
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Bellaire
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Irving
country: United States
state: Texas
city: Kirkland
country: United States
state: Washington
city: Kirkland
country: United States
state: Washington
Study officials:
affiliation: Memory Pharmaceuticals Corp
name: Stephen R Murray, MD, PhD
role: STUDY_DIRECTOR
References: