Risperidone for Schizophrenia

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
SchizophreniaRisperidone - Drug
Eligibility
18 - 35
All Sexes
What conditions do you have?
Select

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

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

4 Primary · 9 Secondary · Reporting Duration: Treatment week 1, treatment week 2, treatment week 3

Week 4
Change in biomarkers of treatment response: Dorsal Caudate (DCA) GABA levels
Baseline and 4th week of of treatment
Changes in neurocognitive performance: MATRICS Consensus Cognitive Battery (MCCB)
Baseline and 4th week of treatment
Change in biomarkers of treatment response: Dorsal Caudate (DCA) Glutamate
Change in biomarkers reflecting treatment response: Medial Prefrontal Cortex (MPFC) GABA
Change in biomarkers reflecting treatment response: Medial Prefrontal Cortex (MPFC) Glutamate
Changes in everyday functioning: University of California San Diego (UCSD) Performance-based Skills Assessment (UPSA)
Day 1
Recreational Substances Used by Patients as Recorded by the Substance Use Questionnaire
Day 1
Participants' Self-Reported Handedness as Recorded by the Edinburgh Handedness Scale
Participants' Verbal I.Q as Assessed by the WTAR to Determine Clinical Eligibility
Week 3
Changes in clinical symptomatology: Positive and Negative Syndrome Scale (PANSS)
Changes in global functioning: Global Assessment of Functioning (GAF)
Changes in motor symptomatology: Abnormal Involuntary Movement Scale (AIMS)
Week 3
Changes in clinical severity: Clinical Global Impression Scale

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Control
1 of 2
Patient
1 of 2

Active Control

Experimental Treatment

90 Total Participants · 2 Treatment Groups

Primary Treatment: Risperidone · No Placebo Group · Phase 4

Patient
Drug
Experimental Group · 1 Intervention: Risperidone · Intervention Types: Drug
ControlNoIntervention Group · 1 Intervention: Control · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Risperidone
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: treatment week 1, treatment week 2, treatment week 3

Who is running the clinical trial?

Columbia UniversityOTHER
1,295 Previous Clinical Trials
1,613,181 Total Patients Enrolled
19 Trials studying Schizophrenia
1,841 Patients Enrolled for Schizophrenia
National Institute of Mental Health (NIMH)NIH
2,552 Previous Clinical Trials
1,823,407 Total Patients Enrolled
228 Trials studying Schizophrenia
87,464 Patients Enrolled for Schizophrenia
Weill Medical College of Cornell UniversityLead Sponsor
986 Previous Clinical Trials
1,338,415 Total Patients Enrolled
6 Trials studying Schizophrenia
224 Patients Enrolled for Schizophrenia
New York State Psychiatric InstituteOTHER
457 Previous Clinical Trials
148,579 Total Patients Enrolled
30 Trials studying Schizophrenia
85,487 Patients Enrolled for Schizophrenia
Dikoma C. Shungu, Ph.D.Principal InvestigatorWeill Medical College of Cornell University
2 Previous Clinical Trials
145 Total Patients Enrolled

Eligibility Criteria

Age 18 - 35 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have the capacity to give informed consent.\n
You are between the ages of 18-35.\n
You are free of antipsychotic medications for at least 3 weeks.
You have a diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder.
References