Status:
RECRUITING
Cromoglicate Adjunctive Therapy for Outpatients With Schizophrenia
Lead Sponsor:
Vishwajit Nimgaonkar, MD PhD
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
Schizophrenia
Schizo Affective Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a double blind adjunctive randomized controlled trial for schizophrenia using cromoglicate.
Detailed Description
Schizophrenia (SZ) extracts a heavy personal and public health cost, primarily because there is no effective treatment. Though many drugs are currently available, the majority provide only partial rel...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03794076
Start Date
April 1 2019
End Date
June 1 2026
Last Update
September 10 2025
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213