Cromoglicate Adjunctive Therapy for Outpatients With Schizophrenia

Description

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

Conditions

Schizophrenia, Schizo Affective Disorder

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Study Overview

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Study Details

Study overview

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

Cromoglicte Adjunctive Therapy for Outpatients With Schizophrenia

Cromoglicate Adjunctive Therapy for Outpatients With Schizophrenia

Condition
Schizophrenia
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

University of Pittsburgh, Pittsburgh, Pennsylvania, United States, 15213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vishwajit Nimgaonkar, MD PhD,

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

Study Record Dates

2025-06