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Clinical Trials in India / NCT04887792
Recruiting Phase 1/2

Acetazolamide for Treatment Resistant Schizophrenia

NCT04887792 · tracked via the Priya Life Science India tracker
Sponsor
Vishwajit Nimgaonkar, MD PhD
Phase
Phase 1/2
Started
2022-02-01
Last updated
2026-07-07

Condition(s) studied

SchizophreniaSchizo Affective Disorder

Investigational drug(s) / intervention(s)

Acetazolamide →Placebo

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.

Study summary

This is a double blind adjunctive randomized controlled trial for schizophrenia using acetazolamide.

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change in positive symptoms — 24 weeks
    Clinical Severity as determined by the Positive and Negative Syndrome Scale (PANSS) positive symptom subscale. The PANSS is a standardized, clinical interview that rates the presence and severity of positive and negative symptoms, as well as general psychopathology for people with schizophrenia within the past week. Symptom severity for each item is rated according to which anchoring points in the 7-point scale (1 = absent; 7 = extreme) best describe the presentation of the symptom. 7 Items, (minimum score = 7, maximum score = 49)

Trial sites (2)

FacilityCityRegionStatus
University of Pittsburgh Pittsburgh Pennsylvania Recruiting
St John's Medical College Hospital Bangalore India Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04887792 on ClinicalTrials.gov ↗ ← All trials in India