RecruitingPhase 1 / Phase 2

Acetazolamide for Treatment Resistant Schizophrenia

A Randomized Controlled Trial of Acetazolamide for Patients With Treatment Resistant Schizophrenia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 55 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 25 years, 50 years, 8 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Persons with SZ have a 10% suicide rate and their lifespan is curtailed by over 25 years."
  • "Used for over 50 years, its side effects (SE) and adverse effects (AE) are well known and are manageable."
  • "ACZ or placebo will be added to prescribed APDs for 8 weeks utilizing the Sequential Parallel Comparison Design to maximize power."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests acetazolamide as an add-on to antipsychotic medicine for schizophrenia. It is for adults ages 18–55 who still have symptoms after trying other antipsychotic medicines.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Give written consent to join the study.
  • Be 18–55 years old. All genders may join.
  • Still have symptoms after two different antipsychotic medicines, each taken at a treatment dose for 6 weeks.
  • Have a total PANSS symptom score above 60, with a score above 4 on at least one item about symptoms such as hearing voices or having false beliefs.
  • Have taken the same dose of antipsychotic medicine for more than 1 month and keep taking it throughout the study.
  • Not be in another clinical trial that assigns treatments by chance.

Who can't join

  • Have had substance abuse in the past month or dependence in the past 6 months. Prescribed methadone for opioid withdrawal is allowed.
  • Have a past or current medical or nervous system illness that could become unstable, such as epilepsy, which causes seizures.
  • Be pregnant.
  • Be allergic to acetazolamide, or have taken it before or be taking it now.
  • Have a history of renal hyperchloremic acidosis, a kidney-related problem that makes the blood too acidic.
  • Have Addison’s disease or adrenal failure, which means the adrenal glands do not make enough hormones.
  • Have chronic closed-angle glaucoma, an eye condition that raises pressure inside the eye.
  • Have an intellectual disability as defined by DSM-5, a guide doctors use to diagnose mental and developmental conditions.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

PA

  • University of Pittsburgh · Pittsburgh, PA 15213Maribeth A Wesesky, BPS · Study contact · 412-295-7017 · weseskyma@upmc.eduSatish Iyengar, Ph.D. · Sub-investigatorKonasale Prasad, M.D. · Sub-investigatorMaribeth A Wesesky, BPS · Sub-investigatorMore trials in Pittsburgh