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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 weeks
Treatment ~ Varies
Follow Up ~approximately 25 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 25 weeks for reporting.

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 more

Awards & 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

Find a Location

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

Media Library

TCT + MEM Clinical Trial Eligibility Overview. Trial Name: NCT04857983 — Phase 2 & 3
Schizophrenia Research Study Groups: TCT + PBO, TCT + MEM
Schizophrenia Clinical Trial 2023: TCT + MEM Highlights & Side Effects. Trial Name: NCT04857983 — Phase 2 & 3
TCT + MEM 2023 Treatment Timeline for Medical Study. Trial Name: NCT04857983 — Phase 2 & 3
~2 spots leftby Dec 2024