Recruiting
Phase 1
Phase 2

Cromoglicate

Sponsor:

Vishwajit Nimgaonkar, MD PhD

Code:

NCT03794076

Conditions

Schizophrenia

Schizo Affective Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Cromoglycate

Placebo

Study Details

Brief summary:

This is a double blind adjunctive randomized controlled trial for schizophrenia using cromoglicate.

Conditions

Schizophrenia

Schizo Affective Disorder

Study ID

NCT03794076

Start date

Apr 1, 2019

Status verified date

Mar, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Cromoglycate

Cromoglycate nasal spray

placebo comparator: Placebo

Saline nasal spray

Interventions

Cromoglycate

Cromoglycate will be administered intranasally (nasal spray) (1 spray each nostril 4 times a day, 5.2 mg/spray

Placebo

Normal saline nasal spray will be administered intranasally (nasal spray) (1 spray each nostril 4 times a day, 5.2 mg/spray)

Primary outcome measure

  • Improvement in positive symptoms [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Vishwajit L Nimgaonkar, M.D., Ph.D.

(412) 246-6353vishwajitNL@upmc.edu

Maribeth A Wesesky, BPS

(412) 310-3108weseskyma@upmc.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Maribeth A Wesesky, BPS

412-310-3108weseskyma@upmc.edu

More Information

Sponsor

Vishwajit Nimgaonkar, MD PhD

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Keywords

  • schizophrenia
  • schizoaffective disorder
  • cromoglicate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vishwajit Nimgaonkar, MD PhD on 2026-03-19.