Cromoglicte Adjunctive Therapy for Outpatients With Schizophrenia

PRO18060112

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

2019-04-01

2024-08-01

2024-08-01

Recruiting

Early phase I

160

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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2024-01-05