Bipolar Disorder With Manic or Mixed EpisodesPhase 2NCT00374920
Safety and Efficacy of MEM 1003 Versus Placebo for the Treatment of Patients With Bipolar I Disorder
A Phase 2 study testing MEM 1003 in people with Bipolar Disorder With Manic or Mixed Episodes, run by Memory Pharmaceuticals at 21 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder With Manic or Mixed Episodes
- What is being tested?
- MEM 1003
- How many people
- 60 participants
- Where
- 21 sitesUnited States
- Study dates
- Sep 2006to Mar 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Study site
Austin, Texas, 78729
Study site
Austin, Texas, 78745
Study site
Austin, Texas, 78756
Study site
Bellaire, Texas, 77401
Study site
Boston, Massachusetts, 02114
Study site
Bradenton, Florida, 34208
Study site
Dallas, Texas, 75228
Study site
Fort Lauderdale, Florida, 33301
Study site
Garden Grove, California, 92845
Study site
Houston, Texas, 77008
Study site
Irving, Texas, 75062
Study site
Kirkland, Washington, 98033
Study site
Kirkland, Washington, 98034
Study site
Lake Charles, Louisiana, 70601
Study site
Little Rock, Arkansas, 72201
Study site
Philadelphia, Pennsylvania, 19149
Study site
Riverside, California, 92506
Study site
San Diego, California, 92105
Study site
Shreveport, Louisiana, 71101
Study site
Torrance, California, 90502
Study site
Willingboro, New Jersey, 08046
About this study
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
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.
Read the 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.
- Being tested
- MEM 1003
- Keywords
- bipolar, mania, mixed
- Medical subject headings
- Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEM 1003Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate at Day 21
Secondary outcomes (1)
Change from baseline to Day 21 in other efficacy measures and safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionDec 2006
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Disorder With Manic or Mixed EpisodesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Memory Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stanley Medical Research Institute
- Investigators
- Stephen R Murray, MD, PhD, Study director, Memory Pharmaceuticals Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374920
- Sponsor's protocol ID
- MEM 1003-101
- Status last verified
- May 2008
- First submitted
- 9 Sep 2006
- Last updated
- 6 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00374920
- Acronym / sponsor ID
- MEM 1003-101
- Keywords
- bipolar, mania, mixed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Memory PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Stanley Medical Research Institute
- Study start
- Sep 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 12 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEM 1003 | Drug | – |
Primary outcome
Response rate at Day 21
1 secondary outcome
Change from baseline to Day 21 in other efficacy measures and safety
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen R Murray, MD, PhD study director
Memory Pharmaceuticals Corp
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MEM 1003 in people with Bipolar Disorder With Manic or Mixed Episodes, run by Memory Pharmaceuticals at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate at Day 21. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2008.