Cromoglicate for Schizophrenia

(CATOS Trial)

Overseen By Satish Iyengar, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Vishwajit Nimgaonkar, MD PhD

Must be taking: Antipsychotics

Must not be taking: Steroids, Immuno-modulators

Disqualifiers: Illicit substance use, Pregnancy, others

Stay on Your Current Meds You can continue your current medications while participating

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

160 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that participants continue taking their current antipsychotic medication at a stable dose throughout the study.

What is the purpose of this trial?

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.

Research Team

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

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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.

Inclusion Criteria

Written informed consent.

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

PANSS total score of 60 and Score 4 or more on one or more items of the 'positive' syndrome items (P1-P7)

Exclusion Criteria

My health is stable except for well-controlled epilepsy.

I have been treated with or am allergic to CGY.

You have not used any illegal drugs in the past 30 days, and have not been dependent on drugs for the past 6 months, except if you are undergoing methadone treatment for opioid withdrawal.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cromoglycate or placebo added to prescribed medications for 4 weeks using the Sequential Parallel Comparison Design

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with primary and secondary outcomes measured over 12 weeks

12 weeks

Treatment Details

Interventions

• Cromoglycate
• Placebo

Trial Overview 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.

Participant Groups

Group I: Cromoglycate Active Control 2 Interventions

Cromoglycate nasal spray

Group II: Placebo Placebo Group 2 Interventions

Saline nasal spray

Who Is Running the Clinical Trial?

Vishwajit Nimgaonkar, MD PhD

Lead Sponsor

Trials

2

Recruited

220+

Stanley Medical Research Institute

Collaborator

Trials

141

Recruited

10,400+