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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Cromoglycate — DRUG
    Cromoglycate will be administered intranasally (nasal spray) (1 spray each nostril 4 times a day, 5.2 mg/spray
  • Placebo — DRUG
    Normal 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: Cromoglycate
    Cromoglycate nasal spray
  • Placebo Comparator: Placebo
    Saline nasal spray

Primary Outcome Measure

Improvement in positive symptoms [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PittsburghPittsburghPennsylvania15213
Maribeth A Wesesky, BPS
412-310-3108
Satish Iyengar, Ph.D. (SUB_INVESTIGATOR)
Konasale Prasad, M.D. (SUB_INVESTIGATOR)
Maribeth A Wesesky, BPS (SUB_INVESTIGATOR)

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