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ANAVEX3-71 30 mg TID (Part A) for Schizophrenia (SZ-001 Trial)
Phase 2
Recruiting
Research Sponsored by Anavex Life Sciences Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has a primary diagnosis of schizophrenia for ≥ 1 year
Stable schizophrenia psychiatric symptoms for at least 6 weeks prior to screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up [part a and part b screening to safety follow up visit] up to 78 days (part a) and up to 114 days (part b)
Awards & highlights
SZ-001 Trial Summary
This trial will test a new drug called ANAVEX3-71 to see if it is safe and effective in treating patients with Schizophrenia. The study will also look at how the drug is
Who is the study for?
Adults aged 18-50 with stable schizophrenia, on consistent antipsychotic medication for at least 6 weeks, and a BMI between 18.5 to 40 kg/m2 can join this trial. They must have a specific cognition score, not be drug or alcohol users, and agree to stay inpatient as required. Pregnant individuals or those with recent investigational drug use are excluded.Check my eligibility
What is being tested?
The study is testing ANAVEX3-71 oral capsules against placebo to assess their safety and effectiveness in treating schizophrenia symptoms. It also looks into how the body processes the drug and its effects on brain function.See study design
What are the potential side effects?
While the side effects of ANAVEX3-71 aren't detailed here, common side effects for similar treatments may include dizziness, gastrointestinal discomfort, changes in weight or appetite, restlessness, and potential metabolic changes.
SZ-001 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with schizophrenia for at least 1 year.
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My schizophrenia symptoms have been stable for at least 6 weeks.
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I am between 18 and 50 years old.
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My mental health score has not worsened by more than 20% and is 80 or less.
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My schizophrenia symptoms are mild based on specific test scores.
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My BMI is between 18.5 and 40, and my weight is over 110 lbs if male, or over 88 lbs if female.
SZ-001 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ [part a and part b screening to safety follow up visit] up to 78 days (part a) and up to 114 days (part b)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~[part a and part b screening to safety follow up visit] up to 78 days (part a) and up to 114 days (part b)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
12-lead ECG (P wave)
12-lead ECG (PR interval)
12-lead ECG (PR segment)
+36 moreSecondary outcome measures
Blood measurements of chitinase-3-like protein 1 (YKL-40)
Blood measurements of circulating amino acid metabolites
Blood measurements of glial fibrillary acidic protein (GFAP)
+5 moreSZ-001 Trial Design
5Treatment groups
Active Control
Placebo Group
Group I: ANAVEX3-71 30 mg TID (Part A)Active Control1 Intervention
The first active treatment arm of the study during Part A (multiple ascending doses).
Group II: ANAVEX3-71 60 mg TID (Part A)Active Control1 Intervention
The second active treatment arm of the study during Part A (multiple ascending doses).
Group III: ANAVEX3-71 TBD mg TID (Part B)Active Control1 Intervention
The active arm of Part B of the study. The dose will be determined based on data obtained in Part A.
Group IV: ANAVEXX3-71 Placebo TID (Part A)Placebo Group1 Intervention
The placebo arm of Part A (multiple ascending doses).
Group V: ANAVEX3-71 Placebo TID (Part B)Placebo Group1 Intervention
The placebo arm of Part B of the study.
Find a Location
Who is running the clinical trial?
Hassman Research InstituteUNKNOWN
Cognitive Research CorporationIndustry Sponsor
23 Previous Clinical Trials
2,290 Total Patients Enrolled
4 Trials studying Schizophrenia
981 Patients Enrolled for Schizophrenia
COGNISIONUNKNOWN
2 Previous Clinical Trials
194 Total Patients Enrolled
1 Trials studying Schizophrenia
161 Patients Enrolled for Schizophrenia
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research trial open to individuals who are 65 years of age or older?
"The trial is accepting individuals who are above 18 years old but below the age of 50."
Answered by AI
Are there any available slots for patients to participate in this clinical trial?
"As per information on clinicaltrials.gov, this specific research study is currently not seeking additional participants. The trial was first listed on 5/15/2024 and last modified on 1/29/2024. Nevertheless, it's worth noting that there are a total of 335 ongoing studies actively recruiting volunteers at present."
Answered by AI
What are the safety considerations for individuals taking ANAVEX3-71 at a dose of 60 milligrams three times daily in Part A of the study?
"Based on our evaluation at Power, the safety rating for ANAVEX3-71 60 mg TID (Part A) is a 2 on a scale of 1 to 3. This assessment reflects existing safety data but lacks evidence supporting effectiveness due to the trial being in Phase 2."
Answered by AI
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