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Acetazolamide for Schizophrenia (APTS Trial)

Phase 1 & 2
Recruiting
Led By Vishwajit L Nimgaonkar, M.D., Ph.D.
Research Sponsored by Vishwajit Nimgaonkar, MD PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
PANSS total score > 60 and Score > 4 on one or more items of the 'positive' syndrome items (P1-P7), following treatment at therapeutic doses for 6 weeks with different APDs on 2 occasions.
Be between 18 and 65 years old
Must not have
History or current medical/neurological illnesses that may lead to unstable course, e.g., epilepsy.
Acetazolamide (ACZ) contraindications: hypersensitivity to ACZ; history of renal hyperchloremic acidosis; Addison's disease/adrenal failure; chronic closed angle-closure glaucoma.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks

Summary

This trial is testing whether the addition of acetazolamide can improve the symptoms of schizophrenia when used alongside the current standard of care. The trial is double blind, meaning that neither the participants nor the researchers will know who is receiving the acetazolamide until after the trial is over.

Who is the study for?
This trial is for adults aged 18-55 with treatment-resistant schizophrenia, having a PANSS score over 60 and significant positive symptoms despite medication. Participants must not be in another study, have taken acetazolamide before, or have certain medical conditions like epilepsy or substance abuse issues.
What is being tested?
The trial tests if acetazolamide can help people whose schizophrenia doesn't respond to usual drugs. It's a double-blind study, meaning neither the patients nor doctors know who gets the real drug versus a placebo (a harmless pill).
What are the potential side effects?
Acetazolamide may cause side effects such as allergic reactions in those sensitive to it, problems related to acid levels in the blood, adrenal gland issues, and might worsen certain types of glaucoma.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My schizophrenia symptoms remain severe despite treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a condition like epilepsy that could make my health unstable.
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I am not allergic to ACZ and do not have renal acidosis, Addison's disease, or chronic glaucoma.
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I have never taken ACZ or had an allergic reaction to it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 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
Change in positive symptoms
Secondary study objectives
Clinical Severity
Cognition
Global Assessment of Function
+4 more

Trial Design

2Treatment groups
Active Control
Group I: AcetazolamideActive Control1 Intervention
acetazolamide capsules
Group II: PlaceboActive Control1 Intervention
Identical gelatin capsules

Find a Location

Who is running the clinical trial?

Vishwajit Nimgaonkar, MD PhDLead Sponsor
1 Previous Clinical Trials
160 Total Patients Enrolled
1 Trials studying Schizophrenia
160 Patients Enrolled for Schizophrenia
Stanley Medical Research InstituteOTHER
140 Previous Clinical Trials
10,334 Total Patients Enrolled
83 Trials studying Schizophrenia
6,267 Patients Enrolled for Schizophrenia
Vishwajit L Nimgaonkar, M.D., Ph.D.Principal InvestigatorUniversity of Pittsburgh

Media Library

Acetazolamide Clinical Trial Eligibility Overview. Trial Name: NCT04887792 — Phase 1 & 2
Schizophrenia Research Study Groups: Acetazolamide, Placebo
Schizophrenia Clinical Trial 2023: Acetazolamide Highlights & Side Effects. Trial Name: NCT04887792 — Phase 1 & 2
Acetazolamide 2023 Treatment Timeline for Medical Study. Trial Name: NCT04887792 — Phase 1 & 2
Schizophrenia Patient Testimony for trial: Trial Name: NCT04887792 — Phase 1 & 2
~2 spots leftby Jan 2025
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