Cromoglicate Adjunctive Therapy for Outpatients With Schizophrenia
This is a double blind adjunctive randomized controlled trial for schizophrenia using cromoglicate.
Conditions:
🦠 Schizophrenia 🦠 Schizo Affective Disorder
🗓️ Study Start (Actual) 1 April 2019
🗓️ Primary Completion (Estimated) August 2024
✅ Study Completion (Estimated) August 2024
👥 Enrollment (Estimated) 160
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Pittsburgh, Pennsylvania, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 2 January 2019
  • First Submitted that Met QC Criteria 3 January 2019
  • First Posted 4 January 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 4 January 2024
  • Last Update Posted 5 January 2024
  • Last Verified January 2024