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Cromoglycate for Schizophrenia and Schizoaffective Disorder

This study is testing if cromoglycate, given as a nasal spray, can help people with schizophrenia or schizoaffective disorder when added to their current medication. Researchers want to see if cromoglycate can improve positive symptoms (like hallucinations or delusions) after 12 weeks. You might receive cromoglycate nasal spray or a placebo (inactive nasal spray). To join, you need to be between 18 and 60 years old, have schizophrenia or schizoaffective disorder, and be on a stable dose of your current antipsychotic medication. The study aims to enroll 160 participants, but its current status is unclear.

Study design
This is a double-blind, randomized controlled trial, meaning neither you nor your doctor will know if you are receiving cromoglycate or a placebo. The study plans to include 160 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is measured at 12 weeks, which suggests follow-up for at least that duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03794076

Cromoglicate Adjunctive Therapy for Outpatients With Schizophrenia

Recruiting
PHASE1Ages 18–65InterventionalTreatment
Vishwajit Nimgaonkar, MD PhD
~160 participants
Updated 2026-03-19 on ClinicalTrials.gov
What's tested:CromoglycatePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Improvement in positive symptoms
Measured over 12 weeks

Conditions

Schizophrenia
Schizo Affective Disorder

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Schizoaffective DisorderSchizophrenia

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Vishwajit L. Nimgaonkar, M.D., Ph.D. · PRINCIPAL_INVESTIGATOR · University of Pittsburgh

Who to contact

Vishwajit L Nimgaonkar, M.D., Ph.D.
[email protected]
(412) 246-6353
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Improvement in positive symptoms12 weeks

    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)