Status:
RECRUITING
Acetazolamide for Treatment Resistant Schizophrenia
Lead Sponsor:
Vishwajit Nimgaonkar, MD PhD
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
Schizophrenia
Schizo Affective Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a double blind adjunctive randomized controlled trial for schizophrenia using acetazolamide.
Detailed Description
Schizophrenia (SZ) afflicts over 21 million people worldwide. Persons with SZ have a 10% suicide rate and their lifespan is curtailed by over 25 years. There is an urgent need for efficacious antipsyc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04887792
Start Date
February 1 2022
End Date
December 30 2026
Last Update
April 3 2025
Active Locations (2)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
2
St John's Medical College Hospital
Bangalore, India