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Cromoglicate Adjunctive Therapy for Outpatients With Schizophrenia
RecruitingPhase 1/2
Cromoglicte Adjunctive Therapy for Outpatients With Schizophrenia
Who can join
Ages 18 to 65 · All sexes
Full 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.
About the study
This is a double blind adjunctive randomized controlled trial for schizophrenia using cromoglicate.
What is being tested
- Cromoglycate (drug)
- Placebo (drug)
Sponsor: Vishwajit Nimgaonkar, MD PhD · Participants: 160 · Started: Apr 1, 2019
Contact the study team
- Vishwajit L Nimgaonkar, M.D., Ph.D. · Phone: (412) 246-6353
- Maribeth A Wesesky, BPS · Phone: (412) 310-3108
Official record on ClinicalTrials.gov — NCT03794076
Locations in the U.S.
| Pennsylvania | University of Pittsburgh, Pittsburgh |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.