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Could a common allergy spray help schizophrenia?

NCT ID NCT03794076

Symptom relief Sponsor: Vishwajit Nimgaonkar, MD PhD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether cromoglicate, a nasal spray used for allergies, can improve symptoms in people with schizophrenia or schizoaffective disorder. Researchers will give 160 adults either the active spray or a placebo, in addition to their usual medication. The goal is to see if it reduces positive symptoms like hallucinations or delusions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cromoglicate (NasalCrom) nasal spray
What this could lead to
If it works, this could offer a new add-on treatment to help control schizophrenia symptoms with fewer side effects.
What could go wrong
This is an early Phase 1/2 trial, so it is small and mainly tests safety. It may not show clear benefit, and the effect could be small or absent.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2019

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Psychotic Disorders schizoaffective disorder schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Schizo affective disorder Schizophrenia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Pittsburgh

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

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