Cromoglicate treatment for outpatients with schizophrenia
Cromoglicte Adjunctive Therapy for Outpatients With Schizophrenia
This study is testing if adding a medication called cromoglicate can help people with schizophrenia or schizoaffective disorder feel better while they continue their usual antipsychotic treatment.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT03794076 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a double-blind, randomized controlled trial investigating the efficacy of cromoglicate as an adjunctive therapy for patients with schizophrenia and schizoaffective disorder. The study aims to identify repurposed drugs that could provide additional relief for psychotic symptoms, negative symptoms, and cognitive impairments associated with these disorders. Participants will be treated with either cromoglicate or a placebo while maintaining a stable dose of their antipsychotic medication. The trial utilizes a novel approach by analyzing protein-protein interaction networks to identify potential drug candidates.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 diagnosed with schizophrenia or schizoaffective disorder who have been stable on antipsychotic medication for at least one month.
Not a fit: Patients with a history of immune disorders, current pregnancy, or those who have previously been treated with cromoglicate may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer improved symptom relief for patients suffering from schizophrenia and schizoaffective disorder.
How similar studies have performed: Other studies have shown promise in repurposing existing medications for new indications, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Vishwajit L. Nimgaonkar, M.D., Ph.D. — University of Pittsburgh
- Study coordinator: Vishwajit L Nimgaonkar, M.D., Ph.D.
- Email: vishwajitNL@upmc.edu
- Phone: (412) 246-6353
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.