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Antipsychotic

Risperidone for Schizophrenia

Phase 4
Waitlist Available
Led By Dikoma C. Shungu, Ph.D.
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Medication free (3 weeks without antipsychotic medications)
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment week 1, treatment week 2, treatment week 3
Awards & highlights

Study Summary

This trial will use magnetic resonance spectroscopy to study the levels of glutamate and - aminobutyric acid in the brains of people with early-stage schizophrenia, in order to develop better biomarkers for treatment response.

Eligible Conditions
  • Schizophrenia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have not taken antipsychotic medication for at least 3 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment week 1, treatment week 2, treatment week 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and treatment week 1, treatment week 2, treatment week 3 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in biomarkers of treatment response: Dorsal Caudate (DCA) GABA levels
Change in biomarkers of treatment response: Dorsal Caudate (DCA) Glutamate
Change in biomarkers reflecting treatment response: Medial Prefrontal Cortex (MPFC) GABA
+1 more
Secondary outcome measures
Changes in clinical severity: Clinical Global Impression Scale
Changes in clinical symptomatology: Positive and Negative Syndrome Scale (PANSS)
Changes in everyday functioning: University of California San Diego (UCSD) Performance-based Skills Assessment (UPSA)
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PatientExperimental Treatment1 Intervention
Medication-free individuals during first-episode of psychosis who will receive 4 weeks of treatment with risperidone
Group II: ControlActive Control1 Intervention
Healthy, psychosis-free controls who will not receive risperidone
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Risperidone
FDA approved

Find a Location

Who is running the clinical trial?

New York State Psychiatric InstituteOTHER
475 Previous Clinical Trials
153,860 Total Patients Enrolled
30 Trials studying Schizophrenia
85,488 Patients Enrolled for Schizophrenia
National Institute of Mental Health (NIMH)NIH
2,782 Previous Clinical Trials
2,689,060 Total Patients Enrolled
248 Trials studying Schizophrenia
89,377 Patients Enrolled for Schizophrenia
Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,481 Total Patients Enrolled
7 Trials studying Schizophrenia
404 Patients Enrolled for Schizophrenia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible for participation in this research experiment?

"This clinical trial seeks 90 participants with schizophrenia spectrum and other psychotic disorders aged between 18-35. Qualified candidates must meet these criteria to be considered for the study."

Answered by AI

What is the current enrollment figure for this clinical trial?

"Affirmative. Clinicaltrials.gov discloses that this research study is actively recruiting patients, which first commenced on September 15th 2017 and has been recently modified on July 28th 2022. A total of 90 participants are being sought from one center."

Answered by AI

What have studies found to be the primary application of Risperidone?

"Risperidone is typically employed to treat acute coryza and multiple other afflictions such as autistic disorder, bipolar disorder, and irritability."

Answered by AI

What potential adverse effects could a person experience from taking Risperidone?

"There is ample evidence to suggest the safety of Risperidone, leading our team to assign it a score of 3 due to its status as an approved Phase 4 treatment."

Answered by AI

Are there any opportunities for subjects to partake in the current trial?

"Affirmative. Clinicaltrials.gov reveals that this trial, first posted on September 15th 2017, is currently recruiting individuals for participation. The clinical team has reserved a quota of 90 patients from one medical centre to partake in the study."

Answered by AI

What are the key goals of this experiment?

"This clinical trial will measure the Change in biomarkers reflecting treatment response: Medial Prefrontal Cortex (MPFC) Glutamate, Changes in motor symptomatology: Abnormal Involuntary Movement Scale (AIMS), Recreational Substances Used by Patients as Recorded by the Substance Use Questionnaire and Changes in clinical severity: Clinical Global Impression Scale over a Baseline to 4th week of treatment time frame. Secondary objectives include analysis of symptoms related to tardive dyskinesia on an AIMS scale ranging from 0-28, whether substance use has increased or decreased since initial assessment based off responses to the"

Answered by AI

Does this investigation encompass geriatric subjects?

"Per the stated requirements, individuals aged 18 to 35 are eligible for inclusion in this research."

Answered by AI

Could you please detail the experiments utilizing Risperidone that have been conducted thus far?

"Currently, 17 trials are underway to research the efficacy of Risperidone. One is in Phase 3 and 139 sites have been designated as testing locations; most of which reside within Toronto, Ontario."

Answered by AI
~6 spots leftby Apr 2025