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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights

APTS Trial 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.Check my eligibility
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).See study design
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.

APTS Trial Eligibility Criteria

Inclusion Criteria

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

APTS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in positive symptoms
Secondary outcome measures
Clinical Severity
Cognition
Global Assessment of Function
+4 more

APTS 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
10,348 Total Patients Enrolled
83 Trials studying Schizophrenia
6,286 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people have signed up for this experiment at most?

"Yes, this is an ongoing study that has been posted since February 1st, 2022. The trial is currently being conducted at 1 location and looking for a total of 60 participants."

Answered by AI

How is Acetazolamide typically employed in medicine?

"Acetazolamide is an effective medical intervention for salicylate intoxication, edema, and open angle glaucoma (oag)."

Answered by AI

Are there any open positions for volunteers in this experiment?

"Yes, this is an active recruitment. The clinical trial was originally posted on 2/1/2022 and has been continuously recruiting since then. They are enrolling 60 patients at 1 site."

Answered by AI

What other precedent is there for using Acetazolamide in medical treatment?

"Acetazolamide is being researched in 17 different clinical trials, 4 of which are Phase 3 studies. The majority of these medical trials take place in Detroit, Michigan, though there are a total of 22 locations running these experiments."

Answered by AI

Could I potentially enroll in this clinical trial?

"Sixty individuals that have been diagnosed with schizophrenia and are between 18-55 years old can participate in this trial. More specifically, patients must have a PANSS total score > 60, a Score > 4 on one or more items of the 'positive' syndrome items (P1-P7), and cannot be participating in another randomized controlled clinical trial (RCT). Additionally, the study is open to both men and women who may not tolerate high ACZ dose."

Answered by AI

Will this experiment be accessible to elderly patients?

"As this trial's eligibility requirements state, the minimum age for participation is 18 and the maximum age is 55."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
University of Pittsburgh
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I’ve tried haldol, risperidone and amisulpride. Limited to no improvement on these drugs.
PatientReceived no prior treatments
~15 spots leftby Jan 2025