Cromoglicate Adjunctive Therapy for Outpatients With Schizophrenia

NCT03794076 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: STUDY19070355
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia; Schizo Affective Disorder

Keywords

schizophrenia; schizoaffective disorder; cromoglicate

Outcome Measures

Primary Outcomes (1)

• Improvement in positive symptoms

  Clinical Severity as determined by the Positive and Negative Syndrome Scale (PANSS) positive symptom subscale. The PANSS is a standardized, clinical interview that rates the presence and severity of positive and negative symptoms, as well as general psychopathology for people with schizophrenia within the past week. Symptom severity for each item is rated according to which anchoring points in the 7-point scale (1 = absent; 7 = extreme) best describe the presentation of the symptom. 7 Items, (minimum score = 7, maximum score = 49)

  12 weeks

Secondary Outcomes (6)

• Total Symptoms

  12 weeks

• Negative Symptoms

  12 weeks

• Cognition

  12 weeks

• Sheehan's disability scale (SDS)

  12 Weeks

• Global Assessment of Function (GAF)

  12 weeks

Other Outcomes (5)

• Total Positive and Negative Syndrome Scale (PANSS)

  12 weeks

• Penn Computerized Neurocognitive Battery (CNB)

  12 weeks

• Sheehan's disability scale (SDS)

  12 weeks

Study Arms (2)

Cromoglycate

ACTIVE COMPARATOR

Cromoglycate nasal spray

Drug: Cromoglycate; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Saline nasal spray

Drug: Cromoglycate; Drug: Placebo

Interventions

Cromoglycate DRUG

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

Also known as: NasalCrom

Cromoglycate; Placebo

Placebo DRUG

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

Also known as: Saline Nasal Spray

Cromoglycate; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vishwajit Nimgaonkar, MD PhD: lead
• Stanley Medical Research Institute: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Cromolyn Sodium

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

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

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

(412) 246-6353; vishwajitNL@upmc.edu

Maribeth A Wesesky, BPS

CONTACT

(412) 310-3108; weseskyma@upmc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant, care providers, Investigators and assessors will all be blinded. Study staff responsible for randomization will be unblinded.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: This study will be a randomized placebo-controlled sequential parallel comparison design (SPCD).

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: January 4, 2019
• Study Start: April 1, 2019
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)