🏛️ Verified NIH Record • Updated 2025-04-30

A Study of ANAVEX3-71 in Adults With Schizophrenia (NCT06245213)

A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Electrophysiology of ANAVEX3-71 in Adult Patients With Schizophrenia in a Multiple Ascending Dose Study (Part A), Followed by a Double-Blind, Randomized, Placebo-Controlled Study (Part B)

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Anavex Life Sciences Corp.

🩺 Plain-English Summary (8th-Grade Level)

A study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and electrophysiology of ANAVEX3-71 in patients with Schizophrenia.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (19 items) and avoid the listed exclusions (12 items).

Location: CenExel Hassman Research Institute — Marlton, New Jersey

Age range: 18 Years to 55 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Participation in a schizophrenia study in which the patient has received any investigational medications within 60 days prior to the baseline visit.
  • History or presence of a clinically significant, poorly treated, or unstable conditions that would jeopardize the safety of the patient or the validity of the study results.
  • Clinically significant abnormal findings on the physical examination, medical history, ECG, or clinical laboratory results at screening.
  • Calgary Depression Scale for schizophrenia (CDSS) score ≥6 at the screening or baseline visits.
  • Simpson Angus Scale (SAS) total score ≥5 at the screening and baseline visits at the screening or baseline visits.
  • Abnormal Involuntary Movement (AIMS) score of 2 for two or more movements or a score of 3 or 4 for any single movement on this scale at the screening or baseline visits.
  • Any primary the DSM-5-TR (American Psychiatric Association 2022) disorder other than schizophrenia within 12 months before screening (confirmed using MINI version 7.0.2 at screening).
  • Pregnant, lactating, or less than 3 months postpartum. Sperm donation is not allowed for 90 days after the final dose of study drug.
  • Risk for suicidal behavior during the study.
  • Inability to detect a 1000 Hz tone at 40 dB in both ears at screening.
  • Has psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days before screening.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • CenExel Hassman Research Institute — Marlton, New Jersey

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Schizophrenia

Explore by condition: All Schizophrenia clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗