Cromoglicate Adjunctive Therapy for Outpatients With Schizophrenia

Recruiting · NCT03794076 · Interventional (participants receive a specific treatment) · Lead sponsor: Vishwajit Nimgaonkar, MD PhD

Interventions studied

CromoglycatePlacebo

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

Age range

18 Years to 65 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 1, Phase 2

Study type

Interventional (participants receive a specific treatment)

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.

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.

1 location listed across 1 US state.