RECRUITING

Cromoglicate Adjunctive Therapy for Outpatients With Schizophrenia

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Conditions

SchizophreniaSchizo Affective Disorderschizoaffective disordercromoglicate

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Cromoglicte Adjunctive Therapy for Outpatients With Schizophrenia

Quick Facts

Study Start:2019-04-01
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03794076

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Written informed consent.
  2. * Both genders, ages 18-60 years
  3. * Schizophrenia / schizoaffective disorder (DSM V).
  4. * Treated with the same APD for at least 60 days; Stable dose of APD for \> 1 month, continued throughout the study.
  5. * PANSS total score of 60 and Score 4 or more on one or more items of the 'positive' syndrome items (P1-P7)
  6. * Preference for patients with duration of psychosis less than 7 years.
  1. * No illicit substance use in last 30 days/no dependence in 6 months with the exception of methadone treatment for opioid withdrawal.
  2. * 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.
  3. * Pregnancy.
  4. * History of immune disorders, HIV infection, or receiving immune-suppressants or immuno-modulators, e.g., steroids.
  5. * Current or prior treatment with CGY or History of hypersensitivity to CGY.
  6. * Intellectual disability as defined in DSM V.

Contacts and Locations

Study Contact

Vishwajit L Nimgaonkar, M.D., Ph.D.
CONTACT
(412) 246-6353
vishwajitNL@upmc.edu
Maribeth A Wesesky, BPS
CONTACT
(412) 310-3108
weseskyma@upmc.edu

Principal Investigator

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

Study Locations (Sites)

University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: Vishwajit Nimgaonkar, MD PhD

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

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

Study Start Date2019-04-01
Study Completion Date2025-06

Study Record Updates

Study Start Date2019-04-01
Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

  • schizophrenia
  • schizoaffective disorder
  • cromoglicate

Additional Relevant MeSH Terms

  • Schizophrenia
  • Schizo Affective Disorder