Cromoglycate Adjunctive Therapy for Outpatients With Schizophrenia

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vishwajit Nimgaonkar, MD PhD
• Collaborator: Stanley Medical Research Institute
• Treatments: Cromolyn Sodium

Criteria

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:

• Substance abuse in the past month/dependence past 6 months.

• History or current medical /neurological illnesses that may lead to an unstable course, e.g., epilepsy.

• 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.