Acetazolamide for Treatment Resistant Schizophrenia
Recruiting · NCT04887792 · Interventional (participants receive a specific treatment) · Lead sponsor: Vishwajit Nimgaonkar, MD PhD
View the official record on ClinicalTrials.gov →Interventions studied
AcetazolamidePlacebo
What this trial is about
This is a double blind adjunctive randomized controlled trial for schizophrenia using acetazolamide.
Who can take part
Age range
18 Years to 55 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
Where it is running
2 locations listed across 1 US state.
- University of Pittsburgh - Pittsburgh, Pennsylvania, United States
- St John's Medical College Hospital - Bangalore, India