RecruitingPhase 1Phase 2NCT03794076
Cromoglicate Adjunctive Therapy for Outpatients With Schizophrenia
Cromoglicte Adjunctive Therapy for Outpatients With Schizophrenia
Sponsor
Vishwajit Nimgaonkar, MD PhD
Enrollment
160 participants
Start Date
Apr 1, 2019
Study Type
INTERVENTIONAL
Conditions
Summary
This is a double blind adjunctive randomized controlled trial for schizophrenia using cromoglicate.
Eligibility
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria6
- 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 Criteria6
- 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.
Interventions
DRUGCromoglycate
Cromoglycate will be administered intranasally (nasal spray) (1 spray each nostril 4 times a day, 5.2 mg/spray
DRUGPlacebo
Normal saline nasal spray will be administered intranasally (nasal spray) (1 spray each nostril 4 times a day, 5.2 mg/spray)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03794076
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