Cromoglicate Adjunctive Therapy for Outpatients With Schizophrenia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVishwajit Nimgaonkar, MD PhD
About this trial
This is a double blind adjunctive randomized controlled trial for schizophrenia using cromoglicate.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Cromoglycate
- Placebo
Treatment groups
160 Participants
are divided into 2 treatment groupsSponsors and collaborators
Vishwajit Nimgaonkar, MD PhD
Lead sponsor
University of Pittsburgh
Sponsor institution
Stanley Medical Research Institute
Collaborator
Source ClinicalTrials.gov