Randomized controlled trial of Acetazolamide to treat schizophrenia

Not Applicable

Conditions: Health Condition 1: F25- Schizoaffective disordersHealth Condition 2: F20- Schizophrenia

Registration Number: CTRI/2021/02/031415

Lead Sponsor: Stanley Medical Research Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Inclusion criteria

Written informed consent.

Both genders, ages 18-55 years (older patients may not tolerate high ACZ dose).

Diagnosis of SZ or SZAD (DSM 5).

PANSS total score > 60 and Score > 4 on one or more items of the â??positiveâ?? syndrome items (P1-P7), following treatment at therapeutic doses for 6 weeks with different APDs on 2 occasions

Stable dose of APD for > 1 month, continued throughout the study.

Not participating in another RCT.

Exclusion Criteria

Exclusion criteria

Substance abuse in the past month/dependence past 6 months, (except nicotine)

History or current medical/neurological illnesses that may lead to unstable course, e.g., epilepsy.

Pregnancy.

ACZ contraindications: hypersensitivity to ACZ; history of renal hyperchloremic acidosis; Addisonâ??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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Among patients with treatment resistant (trSZ)9, study the effect of ACZ augmentation on total symptom scores (TSS) based on the Positive and Negative Syndrome Scale (PANSS) 77, compared with Placebo.Timepoint: Baseline, After intervention (Week 8), After cross over (week 20), after follow up (week 24).

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes include cognitive function, social function and weight. Serum ACZ levels will be monitored.Timepoint: Baseline, After intervention (Week 8), After cross over (week 20), after follow up (week 24).