SchizophreniaPhase 2NCT00097942
Evaluation of the Safety and Efficacy of Memantine as Adjunctive Treatment in Schizophrenia Patients
A Phase 2 study testing memantine HCl in people with Schizophrenia, run by Forest Laboratories at 13 sites in United States.
Trial summary
Standard antipsychotic drug regimens do not fully address the impact of cognitive symptoms associated with schizophrenia. The NMDA receptor has been connected to the pathophysiology of schizophrenia. Memantine is an uncompetitive NMDA receptor antagonist. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- memantine HCl
- How many people
- 138 participants
- Where
- 13 sitesUnited States
- Study dates
- Aug 2004to Sep 2005
- 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
- DSM-IV diagnosed Schizophrenia or schizoaffective disorder who are on a stable antipsychotic regimen with Brief Psychiatric Rating Scale (BPRS) total score greater than or equal to 26 and greater than or equal to 4 on at least one item
Who cannot join
- Secondary diagnosis of Bipolar I disorder
- Suicidal history
- Organic brain disease
- Dementia
- History of substance abuse
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Duke University John Umstead Hospital
Butner, North Carolina, 27509
University of Cincinnati Medical Science Building
Cincinnati, Ohio, 45267-0559
University of Iowa Psychiatric Research
Iowa City, Iowa, 52242
University Hills Clinical Research
Irving, Texas, 75062
Dartmouth Hitchcock Medical School
Lebanon, New Hampshire, 03755
University of Miami Jackson Memorial Hospital
Miami, Florida, 33136
Synergy Clinical Research
National City, California, 91950
Nathan Kline Institute
Orangeburg, New York, 10962
UNC - Chapel Hill, Clinical Research Unit
Raleigh, North Carolina, 27699-3601
CBH Health, LLC
Rockville, Maryland, 20850
Medication Research Clinic
San Antonio, Texas, 78207
VA San Diego Healthcare System
San Diego, California, 92161
Metropolitan Psychiatric Center
St Louis, Missouri, 63112
About this study
Official title: A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Memantine as Adjunctive Treatment to Atypical Antipsychotics in Schizophrenia Patients With Persistent Residual Symptoms
Standard antipsychotic drug regimens do not fully address the impact of cognitive symptoms associated with schizophrenia. The NMDA receptor has been connected to the pathophysiology of schizophrenia. Memantine is an uncompetitive NMDA receptor antagonist. It is hypothesized that adjunctive therapy with memantine will reduce NMDA receptor hyperactivity, improving signal to noise ratio and thereby improving cognitive symptoms.
- Conditions
- Schizophrenia
- Being tested
- memantine HCl
- Keywords
- memantine, adjunctive therapy, schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
memantine HClDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Symptom Scale (PANSS) - Total Score
Secondary outcomes (6)
Clinical Global Impression - Severity (CGI-S)
PANNS - Positive Score
PANSS - Negative Score
Calgary Depression Scale for Schizophrenia
Brief Assessment of Cognition
Clinical Global Impression - Improvement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2004 (estimated)
- Study startAug 2004
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00097942
- Sponsor's protocol ID
- MEM-MD-29
- Status last verified
- Mar 2012
- First submitted
- 1 Dec 2004
- Last updated
- 5 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Memantine as Adjunctive Treatment to Atypical Antipsychotics in Schizophrenia Patients With Persistent Residual Symptoms
- ClinicalTrials.gov ID
- NCT00097942
- Acronym / sponsor ID
- MEM-MD-29
- Conditions
- Schizophrenia
- Keywords
- memantine, adjunctive therapy, schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Aug 2004
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 2 Dec 2004 (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.
Standard antipsychotic drug regimens do not fully address the impact of cognitive symptoms associated with schizophrenia. The NMDA receptor has been connected to the pathophysiology of schizophrenia. Memantine is an uncompetitive NMDA receptor antagonist. It is hypothesized that adjunctive therapy with memantine will reduce NMDA receptor hyperactivity, improving signal to noise ratio and thereby improving cognitive symptoms.
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 (1 listed)
- DSM-IV diagnosed Schizophrenia or schizoaffective disorder who are on a stable antipsychotic regimen with Brief Psychiatric Rating Scale (BPRS) total score greater than or equal to 26 and greater than or equal to 4 on at least one item
Key exclusion criteria (5 listed)
- Secondary diagnosis of Bipolar I disorder
- Suicidal history
- Organic brain disease
- Dementia
- History of substance abuse
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 |
|---|---|---|
| memantine HCl | Drug | – |
Primary outcome
Positive and Negative Symptom Scale (PANSS) - Total Score
6 secondary outcomes
Clinical Global Impression - Severity (CGI-S)
PANNS - Positive Score
PANSS - Negative Score
Calgary Depression Scale for Schizophrenia
Brief Assessment of Cognition
Clinical Global Impression - Improvement
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 5 Mar 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
13 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 memantine HCl in people with Schizophrenia, run by Forest Laboratories at 13 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 1 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 5 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
Positive and Negative Symptom Scale (PANSS) - Total Score. 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 5 Mar 2012.