Cromoglicate Adjunctive Therapy for Outpatients With Schizophrenia

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Schizophrenia, Schizo Affective Disorder

In brief

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

Key facts

Study ID

NCT03794076

Run by

Vishwajit Nimgaonkar, MD PhD

People needed

160

Starts

2019-04-01

Expected to finish

2028-06-01

Last updated by the study team

2026-03-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Pregnancy.
• 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 it is running

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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