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Antipsychotic

Treatment with risperidone for Schizophrenia

N/A
Waitlist Available
Led By Ariel Graff-Guerrero, MD, PhD
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age of 50 and older at time of scanning
Inpatients or outpatients
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 3 months of enrollment
Awards & highlights

Study Summary

This study will provide information regarding dopamine D2/D3 occupancy related with clinical/adverse effects in older people with schizophrenia and schizoaffective disorder. The results of this study will also show an appropriate dose range in order to evade undesirable adverse effects while deriving therapeutic effects, which will directly serve to guide physicians in clinical practice. Furthermore, the findings of this study will elucidate mechanisms underlying older people's increased sensitivity to antipsychotic drugs. In addition, the contribution of D2 and D3 in mediating antipsychotic response will be contrasted, using 2 radiotracers, which has never been tested in an older population. The hypotheses are as follows: First, clinical response (i.e., a ≥ 20% decrease in the Brief Psychiatric Rating Scale total score) will be achieved in older patients with occupancy that is lower than the threshold of 60% in historical young controls. Second, prolactin elevation and EPS will be detected in older patients with occupancies that are lower than the thresholds of 72 and 78% reported in historical young controls. Third, dopamine D2 receptor occupancy will be inversely correlated with subjective well-beings. Fourth, the binding potential and receptor occupancy will be at least 20% lower with [11C]-(+)-PHNO than with [11C]-raclopride in the caudate/putamen. Fifth, the binding of [11C]-(+)-PHNO in the globus pallidus will be higher than that of [11C]-raclopride.

Eligible Conditions
  • Schizophrenia
  • Schizoaffective Disorder
  • Schizophreniform Disorder

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 3 months of enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 3 months of enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The occupancy of risperidone at the D2 and D3 receptor, using [11C]-raclopride and [11C]-(+)-PHNO, respectively.
Secondary outcome measures
Plasma levels of risperidone and 9-hydroxyrisperidone

Side effects data

From 2013 Phase 4 trial • 450 Patients • NCT01157351
12%
Insomnia
9%
Headache
8%
Sedation
8%
Dry Mouth
8%
Anxiety
8%
Depression
8%
Akathisia
7%
Weight Increased
7%
Somnolence
6%
Toothache
6%
Laceration
6%
Nasopharyngitis
5%
Schizophrenia
5%
Upper Respiratory Tract Infection
5%
Dizziness
5%
Suicidal Ideation
4%
Constipation
4%
Hypertension
4%
Increased Appetite
4%
Back Pain
4%
Pain in Extremity
3%
Psychotic Disorder
3%
Nausea
3%
Cough
3%
Diarrhoea
3%
Joint Sprain
3%
Fatigue
3%
Irritability
3%
Hallucination, Auditory
2%
Abnormal Weight Gain
2%
Abdominal Discomfort
2%
Hyperprolactinaemia
2%
Vomiting
2%
Influenza
2%
Bronchitis
2%
Dyskinesia
2%
Dystonia
2%
Agitation
2%
Schizophrenia, Paranoid Type
2%
Extrapyramidal Disorder
2%
Pain
1%
Acute Psychosis
1%
Homicidal Ideation
1%
Dyspepsia
1%
Arthralgia
1%
Tremor
1%
Libido Decreased
1%
Suicide Attempt
1%
Renal Failure Acute
1%
Blood Prolactin Increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Antipsychotics
Paliperidone Palmitate

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment with risperidoneExperimental Treatment1 Intervention
Gradual titration of risperidone according to clinical response
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?

Centre for Addiction and Mental HealthLead Sponsor
353 Previous Clinical Trials
80,934 Total Patients Enrolled
58 Trials studying Schizophrenia
4,217 Patients Enrolled for Schizophrenia
Ariel Graff-Guerrero, MD, PhDPrincipal InvestigatorCentre for Addiction and Mental Health

Frequently Asked Questions

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

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Centre for Addiction and Mental Health
What portion of applicants met pre-screening criteria?
Met criteria
~1 spots leftby Apr 2025