RecruitingPhase 1Phase 2NCT03794076

Cromoglicate Adjunctive Therapy for Outpatients With Schizophrenia

Cromoglicte Adjunctive Therapy for Outpatients With Schizophrenia


Sponsor

Vishwajit Nimgaonkar, MD PhD

Enrollment

160 participants

Start Date

Apr 1, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding a drug called cromoglicate (an anti-inflammatory medication) to existing antipsychotic treatment can further reduce symptoms in people with schizophrenia or schizoaffective disorder. Cromoglicate may help by reducing inflammation in the brain. **You may be eligible if...** - You are between 18 and 60 years old (any gender) - You have been diagnosed with schizophrenia or schizoaffective disorder - You have been on the same antipsychotic medication at a stable dose for at least one month - You still have significant symptoms (a total PANSS score of 60 or more, with at least one positive symptom rated 4 or above) **You may NOT be eligible if...** - You have recently changed your antipsychotic medication or dose - You are outside the 18–60 age range - You have severe medical conditions that would make participation unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCromoglycate

Cromoglycate will be administered intranasally (nasal spray) (1 spray each nostril 4 times a day, 5.2 mg/spray

DRUGPlacebo

Normal saline nasal spray will be administered intranasally (nasal spray) (1 spray each nostril 4 times a day, 5.2 mg/spray)


Locations(1)

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

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NCT03794076


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