Cromoglicate Adjunctive Therapy for Outpatients With Schizophrenia
Part of paid clinical trials in Pittsburgh, Pennsylvania.
- Sponsor
- Vishwajit Nimgaonkar, MD PhD
- Study ID
- NCT03794076
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
- Schizo Affective Disorder
- Schizophrenia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Cromoglycate — DRUGCromoglycate will be administered intranasally (nasal spray) (1 spray each nostril 4 times a day, 5.2 mg/spray
- Placebo — DRUGNormal saline nasal spray will be administered intranasally (nasal spray) (1 spray each nostril 4 times a day, 5.2 mg/spray)
Study Details
This is a double blind adjunctive randomized controlled trial for schizophrenia using cromoglicate.
Key Dates
- Start date
- Apr 1, 2019
- Status verified
- Mar 2026
- Primary completion
- Jan 31, 2028
- Completion
- Jun 30, 2028
Study Design
- Enrollment
- 160 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Active Comparator: CromoglycateCromoglycate nasal spray
- Placebo Comparator: PlaceboSaline nasal spray
Primary Outcome Measure
Improvement in positive symptoms [ Time Frame: 12 weeks ]
Central Contacts
- Vishwajit L Nimgaonkar, M.D., Ph.D.(412) 246-6353
- Maribeth A Wesesky, BPS(412) 310-3108
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | Satish Iyengar, Ph.D. (SUB_INVESTIGATOR) Konasale Prasad, M.D. (SUB_INVESTIGATOR) Maribeth A Wesesky, BPS (SUB_INVESTIGATOR) |
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