RecruitingPhase 1Phase 2NCT04887792
Acetazolamide for Treatment Resistant Schizophrenia
A Randomized Controlled Trial of Acetazolamide for Patients With Treatment Resistant Schizophrenia
Sponsor
Vishwajit Nimgaonkar, MD PhD
Enrollment
60 participants
Start Date
Feb 1, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
This is a double blind adjunctive randomized controlled trial for schizophrenia using acetazolamide.
Eligibility
Min Age: 18 YearsMax Age: 55 Years
Inclusion Criteria5
- Written informed consent.
- Both genders, ages 18-55 years (older patients may not tolerate high ACZ dose).
- 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.
- Stable dose of antipsychotic drug (APD) for \> 1 month, continued throughout the study.
- Not participating in another randomized controlled clinical trial (RCT).
Exclusion Criteria6
- Substance abuse in the past month/dependence past 6 months with the exception of methadone prescribed for opiate withdrawal.
- History or current medical/neurological illnesses that may lead to unstable course, e.g., epilepsy.
- Pregnancy.
- Acetazolamide (ACZ) contraindications: hypersensitivity to ACZ; history of renal hyperchloremic acidosis; Addison's disease/adrenal failure; chronic closed angle-closure glaucoma.
- Current or prior treatment with ACZ or history of hypersensitivity to ACZ.
- Intellectual disability as defined in DSM 5.
Interventions
DRUGAcetazolamide
ACZ 250 mg/day in gelatin capsules will be administered initially and increased over 7-10 days to 2g/day.
DRUGPlacebo
Identical gelatin capsules will be prepared by filling with inert excipients.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04887792
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