NCT03794076RecruitingPhase 1/2
Cromoglicate Adjunctive Therapy for Outpatients With Schizophrenia
Cromoglicte Adjunctive Therapy for Outpatients With Schizophrenia
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
This is a double blind adjunctive randomized controlled trial for schizophrenia using cromoglicate.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 2 Jan 2019
- Start date
- 1 Apr 2019
- Primary completion date
- Jan 2028
- Lead sponsor
- Vishwajit Nimgaonkar, MD PhD
- Diseases
- Schizophrenia
- NCT number
- NCT03794076
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 160
- From 1 Apr 2019 to the primary completion date, Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- No illicit substance use in last 30 days/no dependence in 6 months with the exception of methadone treatment for opioid withdrawal.
- Pregnancy.
- Intellectual disability as defined in DSM V.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.