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Memantine for Cognitive Improvement in Schizophrenia
Phase 2 & 3
Recruiting
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 25 weeks
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
Summary
This trial is testing whether the drug memantine can help people with schizophrenia by improving their cognitive functioning.
Who is the study for?
This trial is for adults aged 18-65 with schizophrenia or schizoaffective disorder, who can understand and communicate in English. They must not have dementia, mental retardation, current drug abuse issues, severe sensory impairments, traumatic brain injury, or be pregnant.
What is being tested?
The study tests if Memantine can boost the effects of targeted cognitive training (TCT) in improving cognitive functions in schizophrenia patients. Participants will either receive Memantine or a placebo alongside TCT sessions and are randomly assigned to these groups.
What are the potential side effects?
Memantine may cause side effects like dizziness, headache, confusion, constipation. It's also possible to experience more serious effects such as shortness of breath or an allergic reaction.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 25 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 25 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
MATRICS Consensus Cognitive Battery Global Composite T-score (MCCB-C)
Positive & Negative Symptom Scale total (PANSSt)
World Health Organization Disability Schedule (WHODAS 2.0)
Secondary study objectives
Current Depressive Symptoms - PHQ-9
Individual MATRICS Consensus Cognitive Battery (MCCB) domain T-scores
Manic Symptoms - Young Mania Rating Scale
+4 moreAwards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: TCT + MEMActive Control1 Intervention
Subjects will be assigned to take memantine and will complete 30 hours of targeted cognitive training in order to assess whether memantine enhances cognitive training performance
Group II: TCT + PBOPlacebo Group1 Intervention
Subjects will be assigned to take placebo and will complete 30 hours of targeted cognitive training in order to assess whether memantine enhances cognitive training performance
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Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,574,978 Total Patients Enrolled
28 Trials studying Schizophrenia
5,855 Patients Enrolled for Schizophrenia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot participate in the study if you have significant hearing or vision problems.You are pregnant.You have problems with drug or alcohol addiction right now and have not been sober for at least 30 days.You have experienced a serious injury to your head in the past.You have been diagnosed with schizophrenia or schizoaffective disorder according to a specific set of criteria.
Research Study Groups:
This trial has the following groups:- Group 1: TCT + PBO
- Group 2: TCT + MEM
Awards:
This trial has 2 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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