Cromoglicate treatment for outpatients with schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a double-blind, randomized controlled trial investigating the efficacy of cromoglicate as an adjunctive therapy for patients with schizophrenia and schizoaffective disorder. The study aims to identify repurposed drugs that could provide additional relief for psychotic symptoms, negative symptoms, and cognitive impairments associated with these disorders. Participants will be treated with either cromoglicate or a placebo while maintaining a stable dose of their antipsychotic medication. The trial utilizes a novel approach by analyzing protein-protein interaction networks to identify potential drug candidates.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Pittsburgh
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Vishwajit L. Nimgaonkar, M.D., Ph.D. — University of Pittsburgh
• Study coordinator: Vishwajit L Nimgaonkar, M.D., Ph.D.
• Email: vishwajitNL@upmc.edu
• Phone: (412) 246-6353

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.