Cromoglicate Adjunctive Therapy for Outpatients With Schizophrenia
Cromoglicte Adjunctive Therapy for Outpatients With Schizophrenia
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 65 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 4 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "CGY or placebo will be added to prescribed medications for 4 weeks utilizing the Sequential Parallel Comparison Design to maximize power."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests cromoglicate added to ongoing treatment for schizophrenia. It is for adults ages 18–60 with schizophrenia or schizoaffective disorder who receive care without staying in a hospital.
This is a double blind adjunctive randomized controlled trial for schizophrenia using cromoglicate.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Give written consent to join the study.
- Be age 18–60. All genders may join.
- Have schizophrenia or schizoaffective disorder, which involves symptoms of schizophrenia and mood problems.
- Have taken the same antipsychotic medicine for at least 60 days, with the same dose for more than 1 month. Continue that dose during the study.
- Have a total PANSS symptom rating score of 60, with at least one “positive symptom,” such as hearing things others do not, rated 4 or higher.
- People who have had psychosis for less than 7 years are preferred.
Who can't join
- Illegal drug use in the past 30 days or drug dependence in the past 6 months. Methadone treatment for opioid withdrawal is allowed.
- A past or current medical or nervous system illness that could become unstable. Epilepsy is allowed if medicine has controlled it well for at least 6 months.
- Being pregnant.
- A history of immune system disorders, HIV infection, or taking medicines that weaken or change the immune system, such as steroids.
- Past or current treatment with CGY, or a history of an allergic reaction to CGY.
- An intellectual disability, as defined by standard mental health guidelines.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (1)
PA
- University of Pittsburgh · Pittsburgh, PA 15213Maribeth A Wesesky, BPS · Study contact · 412-310-3108 · weseskyma@upmc.eduSatish Iyengar, Ph.D. · Sub-investigatorKonasale Prasad, M.D. · Sub-investigatorMaribeth A Wesesky, BPS · Sub-investigatorMore trials in Pittsburgh