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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

CATOS Trial Summary

This trial is testing whether cromoglicate can help treat schizophrenia when used in addition to other treatments. The trial is double blind, meaning neither the participants nor the researchers will know who is receiving cromoglicate or a placebo until the trial is over.

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.Check my eligibility

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.See study design

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.

CATOS Trial 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.

CATOS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Improvement in positive symptoms

Secondary outcome measures

Cognition

Negative Symptoms

Total Symptoms

Other outcome measures

Global Assessment of Function (GAF)

Penn Computerized Neurocognitive Battery (CNB)

Quality of Life Scale (QOL)

+2 more

CATOS 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vishwajit Nimgaonkar, MD PhDLead Sponsor

1 Previous Clinical Trials

60 Total Patients Enrolled

1 Trials studying Schizophrenia

60 Patients Enrolled for Schizophrenia

Stanley Medical Research InstituteOTHER

140 Previous Clinical Trials

10,248 Total Patients Enrolled

83 Trials studying Schizophrenia

6,186 Patients Enrolled for Schizophrenia

Vishwajit L. Nimgaonkar, M.D., Ph.D.Principal InvestigatorUniversity of Pittsburgh

Media Library

Cromoglycate Clinical Trial Eligibility Overview. Trial Name: NCT03794076 — Phase 1 & 2

Schizophrenia Research Study Groups: Placebo, Cromoglycate

Schizophrenia Clinical Trial 2023: Cromoglycate Highlights & Side Effects. Trial Name: NCT03794076 — Phase 1 & 2

Cromoglycate 2023 Treatment Timeline for Medical Study. Trial Name: NCT03794076 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How is Cromoglycate typically utilized in the medical field?

"Patients suffering from vernal keratoconjunctivitis, conjunctivitis, and food allergies can find relief through Cromoglycate."

Answered by AI

How many individuals have enrolled in this experiment?

"Affirmative. According to information from clinicaltrials.gov, this investigation is actively recruiting suitable candidates and posted for the first time on April 1st 2019; it was most recently updated on March 4th 2022. 160 participants are required from one medical centre."

Answered by AI

Am I eligible to become part of this clinical experiment?

"The research team is seeking 160 participants with schizophrenia and aged between 18-65. Those who meet these criteria will be eligible for the clinical trial."

Answered by AI

Does this examination offer participation to those of advanced age?

"Patients between the ages of 18 to 65 can enrol in this experiment. Alternatively, there are 108 separate trials for minors and 248 tailored studies available for seniors aged over 65 years old."

Answered by AI

Are enrollment opportunities still available for this medical experiment?

"Affirmative, the information hosted on clinicaltrials.gov verifies that this medical experiment is presently seeking volunteers. It was initially listed on April 1st 2019 and most recently modified on March 4th 2022. 160 patients are required to be recruited at a single facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cromoglicate Adjunctive Therapy for Outpatients With Schizophrenia

Vishwajit Nimgaonkar, MD PhD 2019. "Cromoglicate Adjunctive Therapy for Outpatients With Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03794076.

All > Schizophrenia