Cromoglicate Adjunctive Therapy for Outpatients With Schizophrenia

Launched by VISHWAJIT NIMGAONKAR, MD PHD · Jan 3, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called cromoglicate as an additional treatment for people with schizophrenia and schizoaffective disorder. The goal is to see if cromoglicate can help improve symptoms when added to a stable treatment plan. The study is currently looking for participants aged 18 to 60 who have been on the same antipsychotic medication for at least 60 days and are experiencing specific symptoms of their condition. To join, participants must agree to take part in the study and meet other health criteria.

If you or someone you know is interested in participating, you can expect to be part of a double-blind trial, meaning neither you nor the researchers will know who is receiving the cromoglicate and who is receiving a placebo (a treatment with no active medication). This helps ensure that the results are fair and unbiased. It’s important to note that participants should not have used certain substances recently or have certain medical conditions, like pregnancy or immune disorders. Overall, this trial aims to explore a potential new option for improving treatment for those with schizophrenia.

Gender

ALL

Eligibility 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:
• • 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.