What side effects are associated with this type of intervention?

Common treatments for schizophrenia include antipsychotic medications such as clozapine, olanzapine, risperidone, and aripiprazole. Known side effects of these medications can include weight gain, metabolic abnormalities (such as diabetes and hyperglycemia), sedation, extrapyramidal symptoms (such as tremors and rigidity), and cardiovascular issues. Clozapine, in particular, can cause agranulocytosis, myocarditis, and seizures. While cromoglicate is not a standard treatment for schizophrenia, its side effects are generally mild and include local irritation and stinging.

What prior FDA approvals exist?

FDA-approved treatments for schizophrenia primarily include antipsychotic medications, which are divided into first-generation (typical) and second-generation (atypical) antipsychotics. Examples include haloperidol and chlorpromazine (first-generation) and risperidone, olanzapine, and aripiprazole (second-generation). These drugs primarily work by blocking dopamine receptors to reduce psychotic symptoms. While cromoglicate, a mast cell stabilizer, is being studied for its potential benefits in schizophrenia, there are no current FDA-approved treatments for schizophrenia that specifically target mast cell stabilization and prevention of inflammatory mediator release.

What other types of research exist?

Promising novel alternatives to Cromoglicate for schizophrenia treatment in 2024 include second-generation antipsychotics like aripiprazole and clozapine, which have shown efficacy in managing symptoms. Additionally, emerging treatments such as glutamate modulators (e.g., glycine reuptake inhibitors) and anti-inflammatory agents (e.g., minocycline) are being explored for their potential benefits in schizophrenia management.

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Cromoglicate for Schizophrenia (CATOS Trial)

Phase 1 & 2

Recruiting

Led By Vishwajit L. Nimgaonkar, M.D., Ph.D.

Research Sponsored by Vishwajit Nimgaonkar, MD PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Treated with the same APD for at least 60 days; Stable dose of APD for > 1 month, continued throughout the study.

Both genders, ages 18-60 years

Must not have

Current or prior treatment with CGY or History of hypersensitivity to CGY.

History of immune disorders, HIV infection, or receiving immune-suppressants or immuno-modulators, e.g., steroids.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Summary

This trial tests a drug used for asthma and allergies on schizophrenia patients who don't fully respond to standard treatments. The drug may help by protecting the brain and targeting specific brain proteins. The drug has been used for years in treating asthma and allergies, showing effectiveness in stabilizing certain cells in the body and reducing the need for other medications.

Who is the study for?

This trial is for adults aged 18-60 with schizophrenia or schizoaffective disorder, stable on antipsychotic drugs for over a month. Participants must have moderate symptoms and can't have unstable medical conditions, be pregnant, use illicit substances recently, or have intellectual disabilities.

What is being tested?

The study tests Cromoglicate as an add-on treatment in outpatients with schizophrenia. It's a double-blind trial where patients are randomly assigned to receive either Cromoglicate or a placebo without knowing which one they're getting.

What are the potential side effects?

While the specific side effects of Cromoglicate in this context aren't detailed here, common ones may include coughing, throat irritation or dryness, wheezing, and rarely allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on the same medication for over 60 days and my dose has not changed for more than a month.

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I am between 18 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with or am allergic to CGY.

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I have an immune disorder, HIV, or am taking immune-suppressing drugs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Improvement in positive symptoms

Secondary study objectives

Cognition

Negative Symptoms

Total Symptoms

Other study objectives

Global Assessment of Function (GAF)

Penn Computerized Neurocognitive Battery (CNB)

Quality of Life Scale (QOL)

+2 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: CromoglycateActive Control2 Interventions

Cromoglycate nasal spray

Group II: PlaceboPlacebo Group2 Interventions

Saline nasal spray

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for schizophrenia include antipsychotics and anti-inflammatory agents. Antipsychotics work by blocking dopamine receptors, reducing symptoms like hallucinations and delusions. Anti-inflammatory agents, such as cromoglicate, aim to reduce inflammation and modulate the immune response, which may contribute to the disease. This dual approach is significant as it could address a broader range of symptoms, potentially improving overall treatment outcomes for schizophrenia patients.

Efficacy and safety of anti-inflammatory agents in treatment of psychotic disorders - A comprehensive systematic review and meta-analysis.Systematic review and meta-analysis of the efficacy and safety of minocycline in schizophrenia.Adjunctive use of anti-inflammatory drugs for schizophrenia: A meta-analytic investigation of randomized controlled trials.