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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00374920

Enrollment

Registered

2006-09-12

Start date

2006-09-30

Completion date

2007-03-31

Last updated

2008-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder With Manic or Mixed Episodes

Keywords

bipolar, mania, mixed

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.

Interventions

DRUGMEM 1003

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Response rate at Day 21	—

Secondary

Measure	Time frame
Change from baseline to Day 21 in other efficacy measures and safety	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026