Adding Cromoglycate Nasal Spray to Standard Treatment for Adults With Schizophrenia or Schizoaffective Disorder

What this Trial Is About

Researchers are evaluating cromoglycate as an additional treatment for outpatients with schizophrenia. Schizophrenia is a challenging condition with limited effective treatments, especially for persistent symptoms and cognitive problems. This trial focuses on patients who continue to have positive symptoms despite stable antipsychotic medication. The study uses a double-blind, randomized controlled design to carefully assess the potential benefits of cromoglycate, a drug known for its safety and ability to stabilize the blood-brain barrier, which may be disrupted in schizophrenia. Participants will receive either cromoglycate nasal spray or a placebo spray, both administered as one spray in each nostril four times daily, for a total of 4 weeks. The study uses a Sequential Parallel Comparison Design to enhance the reliability of results. Cromoglycate, traditionally used for asthma and allergies, is being tested to see if it improves schizophrenia symptoms when added to current antipsychotic therapy. The trial includes two groups one receiving the active cromoglycate spray and the other receiving a saline placebo spray. Throughout the 12-week study period, participants will be monitored for changes in positive symptoms using the PANSS scale, along with assessments of total symptoms, negative symptoms, cognition, social function, and quality of life. Serum levels of cromoglycate will also be measured to track adherence and drug exposure. The study includes regular evaluations to ensure safety and to gather comprehensive data on how cromoglycate may impact schizophrenia symptoms and functioning.

Cromoglicate Adjunctive Therapy for Outpatients With Schizophrenia