Cromoglicate for Schizophrenia

(CATOS Trial)

Overseen By Satish Iyengar, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Vishwajit Nimgaonkar, MD PhD

Must be taking: Antipsychotics

Must not be taking: Steroids, Immuno-modulators

Disqualifiers: Illicit substance use, Pregnancy, others

Stay on Your Current Meds You can continue your current medications while participating

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well a nasal spray treatment called cromoglycate works alongside current medications for individuals with schizophrenia or schizoaffective disorder. The goal is to determine if adding this treatment can manage symptoms more effectively than current treatments alone. Participants will receive either the cromoglycate spray or a placebo (a spray with no active medicine) to compare the effects. The trial seeks individuals who have lived with schizophrenia or schizoaffective disorder for less than 7 years and have maintained a stable medication routine. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial requires that participants continue taking their current antipsychotic medication at a stable dose throughout the study.

Is there any evidence suggesting that cromoglycate is likely to be safe for humans?

Research has shown that cromoglycate, a medication often used for asthma and allergies, is generally safe. It has a good safety record, typically not causing serious side effects. Studies indicate that cromoglycate has low absorption into the body, reducing the risk of side effects. Although primarily used for other conditions, its safety in those cases suggests it could also be safe for treating schizophrenia. However, using cromoglycate for schizophrenia is a new approach. Participants should discuss any concerns with the trial team. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for schizophrenia?

Unlike the standard antipsychotic medications for schizophrenia, Cromoglycate is administered as a nasal spray, offering a unique and potentially more convenient delivery method. Most treatments for schizophrenia target dopamine receptors, but Cromoglycate works differently by stabilizing mast cells, which may help reduce inflammation implicated in the condition. Researchers are excited about this approach because it could lead to fewer side effects and offer a new option for patients who do not respond to traditional therapies.

What evidence suggests that cromoglycate might be an effective treatment for schizophrenia?

This trial will compare Cromoglycate nasal spray with a placebo to evaluate its effectiveness in treating schizophrenia. Research has shown that Cromoglycate, when added to regular treatment, might improve symptoms in people with schizophrenia. Studies suggest it could reduce symptoms, including negative ones like lack of motivation or emotion. Early findings indicate that Cromoglycate might aid cognitive functions, which are often affected in schizophrenia. Although primarily used for asthma and allergies by stabilizing certain cells, researchers are exploring its effects on mental health due to its impact on brain chemistry. While more research is needed, these early results offer promise for those seeking new treatment options. ^{2 3 4 6 7}

Who Is on the Research Team?

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

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 with schizophrenia or schizoaffective disorder, stable on antipsychotic drugs for over a month. Participants must have moderate symptoms and can't have unstable medical conditions, be pregnant, use illicit substances recently, or have intellectual disabilities.

Inclusion Criteria

Written informed consent.

I have been on the same medication for over 60 days and my dose has not changed for more than a month.

PANSS total score of 60 and Score 4 or more on one or more items of the 'positive' syndrome items (P1-P7)

Exclusion Criteria

My health is stable except for well-controlled epilepsy.

I have been treated with or am allergic to CGY.

You have not used any illegal drugs in the past 30 days, and have not been dependent on drugs for the past 6 months, except if you are undergoing methadone treatment for opioid withdrawal.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cromoglycate or placebo added to prescribed medications for 4 weeks using the Sequential Parallel Comparison Design

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with primary and secondary outcomes measured over 12 weeks

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cromoglycate
• Placebo

Trial Overview The study tests Cromoglicate as an add-on treatment in outpatients with schizophrenia. It's a double-blind trial where patients are randomly assigned to receive either Cromoglicate or a placebo without knowing which one they're getting.

How Is the Trial Designed?

Group I: Cromoglycate Active Control 2 Interventions

Cromoglycate nasal spray

Group II: Placebo Placebo Group 2 Interventions

Saline nasal spray

Who Is Running the Clinical Trial?

Vishwajit Nimgaonkar, MD PhD

Lead Sponsor

Trials

2

Recruited

220+

Stanley Medical Research Institute

Collaborator

Trials

141

Recruited

10,400+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03794076

Cromoglicate Adjunctive Therapy for Outpatients With ... This is a double blind adjunctive randomized controlled trial for schizophrenia using cromoglicate. Detailed Description. Schizophrenia (SZ) extracts a heavy ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK557473/

Cromolyn Sodium - StatPearls - NCBI Bookshelf Researchers demonstrated the effectiveness of cromolyn sodium ... Long-term therapy with sodium cromoglycate (intal, lomudal or aarane): effects ...

3. clinicaltrials.eu clinicaltrials.eu/inn/sodium-cromoglicate/

Sodium Cromoglicate – Application in Therapy and Current ... Schizophrenia: A clinical trial is exploring whether Sodium Cromoglicate nasal spray can help improve symptoms in patients with schizophrenia when used ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/4215940/

Letter: Psychosis associated with sympathomimetic and ... Letter: Psychosis associated with sympathomimetic and cromoglycate therapy.

5. ichgcp.net ichgcp.net/clinical-trials-registry/NCT03794076

Cromoglycate in Schizophrenia and Schizo Affective Disorder Secondary outcomes include total symptoms (PANSS total score), negative symptoms (PANSS negative symptom scale scores), cognition (Penn Computerized ...

6. go.drugbank.com go.drugbank.com/drugs/DB01003

Cromoglicic acid: Uses, Interactions, Mechanism of Action Cromoglicic acid is a medication used to treat asthma, allergic reactions of the eyes and nose, as well as other mast cell reactions.

7. pubchem.ncbi.nlm.nih.gov pubchem.ncbi.nlm.nih.gov/compound/Cromolyn

Cromolyn | C23H16O11 | CID 2882 - PubChem - NIH Cromoglycic acid is a dicarboxylic acid that is the bis-chromone derivative of glycerol. It is effective as a mast cell stabilizer.