Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2022-02-01
2026-12-30
Brief Summary
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Detailed Description
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ACZ crosses the blood-brain barrier. It is used to treat CNS diseases such as refractory seizures and idiopathic intracranial hypertension. Used for over 50 years, its side effects (SE) and adverse effects (AE) are well known and are manageable. It is a potent, specific inhibitor of carbonic anhydrase (CA), which catalyzes the conversion of CO2 to HCO3- and H+. CA is localized to pre-synaptic terminals and glial cells. It modulates GABAergic excitation, long-term synaptic transformation, attentional gating of memory storage and cerebrospinal fluid formation. Post-mortem brain and serological studies show raised CA levels in patients with psychotic/mood disorders. Several APDs also inhibit CA. The investigators thus postulate brain CA inhibition as the therapeutic target for ACZ in SZ.
The investigators propose a double-blind, crossover RCT for SZ using adjunctive ACZ. To maximize the risk/benefit ratio, the investigators will enroll inpatients and outpatients with treatment resistant SZ (trSZ) who meet defined criteria (N=60 RCT completers). ACZ or placebo will be added to prescribed APDs for 8 weeks utilizing the Sequential Parallel Comparison Design to maximize power. The investigators have extensive experience with RCTs. The investigators will ensure timely recruitment by approaching a large group of patients we serve, across 2 sites. If ACZ is beneficial, in future studies the investigators will pursue its implementation for trSZ, and seek variables associated with treatment response.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Acetazolamide
acetazolamide capsules
Acetazolamide
ACZ 250 mg/day in gelatin capsules will be administered initially and increased over 7-10 days to 2g/day.
Placebo
Identical gelatin capsules
Placebo
Identical gelatin capsules will be prepared by filling with inert excipients.
Interventions
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Acetazolamide
ACZ 250 mg/day in gelatin capsules will be administered initially and increased over 7-10 days to 2g/day.
Placebo
Identical gelatin capsules will be prepared by filling with inert excipients.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
ALL
No
Sponsors
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Stanley Medical Research Institute
OTHER
Vishwajit Nimgaonkar, MD PhD
OTHER
Responsible Party
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Vishwajit Nimgaonkar, MD PhD
Professor of Psychiatry and Human Genetics
Principal Investigators
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Vishwajit L Nimgaonkar, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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University of Pittsburgh
Pittsburgh, Pennsylvania, United States
St John's Medical College Hospital
Bangalore, , India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY20010237
Identifier Type: -
Identifier Source: org_study_id
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