NCT03794076 · Vishwajit Nimgaonkar, MD PhD
Cromoglicate Adjunctive Therapy for Outpatients With Schizophrenia
(CATOS)
What this study is about
This is a double blind adjunctive randomly assigned controlled trial for schizophrenia using cromoglicate.
View original scientific description
This is a double blind adjunctive randomized controlled trial for schizophrenia using cromoglicate.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Written informed consent.
- Both genders, ages 18-60 years
- Schizophrenia / schizoaffective disorder (DSM V).
- Treated with the same APD for at least 60 days; Stable dose of APD for \> 1 month, continued throughout the study.
- PANSS total score of 60 and Score 4 or more on one or more items of the 'positive' syndrome items (P1-P7)
- Preference for patients with duration of psychosis less than 7 years.
Exclusion criteria
- No illicit substance use in last 30 days/no dependence in 6 months with the exception of methadone treatment for opioid withdrawal.
- History or current medical /neurological illnesses that may lead to an unstable course with the exception of epilepsy which is well-controlled on an antiepileptic medication for at least 6 months.
- History of immune disorders, HIV infection, or receiving immune-suppressants or immuno-modulators, e.g., steroids.
- Current or prior treatment with CGY or History of hypersensitivity to CGY.
- Intellectual disability as defined in DSM V.
Where
- Pittsburgh, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 19, 2026 · Source of record for eligibility and locations