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risperidone

Phase 3

Anxiety Disorders | Small molecule | Psychiatry |Johnson & Johnson|Last Updated: Oct 15, 2015

Target and mechanism

ModalitySmall molecule

Also known as Risperidone, oral formulation, Risperidone, formulation, Risperidone, oral tablets, Risperidone, long-acting injectable, risperidone oral tablets, Risperidone oral solution, Oral Risperidone

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment301

FDA Designations

No designations recorded

Clinical trial landscape

risperidone · 40 trials · 31 indications

Phase 3 39Phase 1 1
NCT01624675A Study to Evaluate the Efficacy and Safety of Risperidone (R064766) in Children and Adolescents With Irritability Associated With Autistic DisorderAutistic Disorder in Children and Adolescents
COMPLETED39 Analytics
NCT00246272An Open-label Study Evaluating the Maintenance of Clinical Effect in Adult Schizophrenia Patients Switched From Risperidone Tablets to an Equivalent Dose of a Rapidly-dissolving Tablet Formulation of RisperdoneSchizophrenia
COMPLETED82 Analytics
NCT00095134Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard TherapyMajor Depressive Disorder
COMPLETED630 Analytics
NCT00088075Investigate Risperidone for the Treatment of Schizophrenia in AdolescentsSchizophrenia
COMPLETED160 Analytics
NCT00240708A Study of the Efficacy and Safety of Long-acting Injectable Risperidone and Risperidone Tablets in Patients With SchizophreniaSchizophrenia
COMPLETED205 Analytics
NCT00216580A Pilot Study of the Use of Risperidone Long Acting Injectable in the Treatment of Patients With Recent Onset PsychosisSchizophrenia
COMPLETED50 Analytics
NCT00246246A Randomized, Open-label Trial of Long-acting Injectable Risperidone Versus Oral Antipsychotic Medication in Patients With Bipolar DisorderBipolar Disorder
COMPLETED48 Analytics
NCT00076115Study to Determine the Effectiveness of Risperidone in Bipolar Disorder in Children and AdolescentsBipolar Disorder
COMPLETED13 Analytics
NCT00254930A Prospective Study of Risperdal (Risperidone) for the Treatment of Behavioral Disorder Following Psychological Therapy for Challenging Behavior in Learning Disabled ChildrenLearning Disorders
COMPLETED19 Analytics
NCT00044681A Study of the Effectiveness and Safety of Risperidone to Augment SSRI Therapy in Patients With Treatment-resistant DepressionDepressive Disorder
COMPLETED258 Analytics
PHASE3COMPLETED
A Study to Evaluate the Efficacy and Safety of Risperidone (R064766) in Children and Adolescents With Irritability Associated With Autistic Disorder
Autistic Disorder in Children and Adolescents
NCT0162467539
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PHASE3COMPLETED
An Open-label Study Evaluating the Maintenance of Clinical Effect in Adult Schizophrenia Patients Switched From Risperidone Tablets to an Equivalent Dose of a Rapidly-dissolving Tablet Formulation of Risperdone
Schizophrenia
NCT0024627282
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PHASE3COMPLETED
Study Comparing Adjunctive Risperidone Versus Placebo in Major Depressive Disorder That Is Not Responding to Standard Therapy
Major Depressive Disorder
NCT00095134630
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PHASE3COMPLETED
Investigate Risperidone for the Treatment of Schizophrenia in Adolescents
Schizophrenia
NCT00088075160
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PHASE3COMPLETED
A Study of the Efficacy and Safety of Long-acting Injectable Risperidone and Risperidone Tablets in Patients With Schizophrenia
Schizophrenia
NCT00240708205
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PHASE3COMPLETED
A Pilot Study of the Use of Risperidone Long Acting Injectable in the Treatment of Patients With Recent Onset Psychosis
Schizophrenia
NCT0021658050
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PHASE3COMPLETED
A Randomized, Open-label Trial of Long-acting Injectable Risperidone Versus Oral Antipsychotic Medication in Patients With Bipolar Disorder
Bipolar Disorder
NCT0024624648
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PHASE3COMPLETED
Study to Determine the Effectiveness of Risperidone in Bipolar Disorder in Children and Adolescents
Bipolar Disorder
NCT0007611513
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PHASE3COMPLETED
A Prospective Study of Risperdal (Risperidone) for the Treatment of Behavioral Disorder Following Psychological Therapy for Challenging Behavior in Learning Disabled Children
Learning Disorders
NCT0025493019
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PHASE3COMPLETED
A Study of the Effectiveness and Safety of Risperidone to Augment SSRI Therapy in Patients With Treatment-resistant Depression
Depressive Disorder
NCT00044681258
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Study Endpoints

Primary Endpoints

The change from baseline in the Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale scores
Baseline, Week 8

The ABC-J Irritability subscale consists of 15 items. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Higher scores represent worse condition.

CGI-Severity (CGI-S) score for maintenance of clinical effect
Difference in therapeutic effect of risperidone and placebo as measured by change in depression rating scale (HAM-D) at end of week 4 of the double-blind phase.
Change in total PANSS (Positive and Negative Syndrome Scale for Schizophrenia) from baseline to the 6-week endpoint
Positive and Negative Syndrome Scale (PANSS) at screening, Weeks 8, 16, and 24.
Change in Positive and Negative Syndrome Scale (PANSS) from baseline to end of study
Changes in the Clinical Global Impression - Severity of Illness subscale (CGI-S) from baseline to endpoint, compared between treatment groups
The change in the total YMRS score from baseline at the 3-week endpoint
Change compared to baseline in total score of the Aberrant Behaviour Checklist (ABC)
Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score at end of treatment; time to relapse
Effectiveness measured by incidence of symptom reoccurrence (relapse) in 1 year.
To accumulate long-term safety data: incidence of adverse events and clinical evaluations (physical exam, laboratory tests) conducted throughout the trial.
Time from start of double-blind phase to relapse, using N-CBRF and CGI assessments.
To accumulate long-term safety data: incidence of adverse events and clinical evaluations (physical examination, Extrapyramidal Symptom Rating Scale [ESRS], laboratory tests, ECGs).
To document the long-term safety of 25, 37.5 and 50 mg long-acting injectable risperidone from baseline until study end point.
Incidence, type, and severity of treatment-emergent adverse events throughout the treatment period.
Change in total PANSS (Positive and Negative Syndrome Scale for Schizophrenia) from baseline to the 8-week endpoint
Change of Positive and Negative Syndrome Scale for Schizophrenia (PANSS) score from baseline to each visit during treatment; incidence of adverse events throughout study
Acute efficacy: Change in Young Mania Rating Scale (YMRS) total score from baseline to endpoint of 3 weeks of acute treatment period.
Change in Young Mania Rating Scale (YMRS) total score from baseline to end of treatment.
Change in Young Mania Rating Scale (YMRS) total score from baseline to the end of treatment.
Change from baseline to end of treatment (Week 8) in Psychosis Cluster Score of Pathology from the Behavioral Pathology in Alzheimer's Disease (BEHAVE-AD) Rating Scale and Clinical Global Impression (CGI).
Mean change from baseline to Week 13 for total score using the Structured Clinical Interview- Positive and Negative Syndrome Scale (SCI-PANSS)
To document the long-term safety of 25, 50 and 75 mg long-acting injectable risperidone from baseline until study endpoint.
Incidence of adverse events; Injection site evaluation; Extrapyramidal Sympton Rating Scale (ESRS) results at each visit for at least 1 year; Clinical evaluations (physical exams, laboratory tests) will be conducted throughout trial
Change from baseline to the end of double-blind treatment in the PANSS (Positive and Negative Syndrome Scale for Schizophrenia) total score
Change in the Irritability Subscale of the Aberrant Behavior Checklist (ABC) and other ABC subscales at end of treatment compared with baseline
Change from baseline to the end of double-blind treatment in total aggression score of the CMAI (Cohen-Mansfield Agitation Inventory).
Change in Young Mania Rating Scale (YMRS) total score from baseline to end of double-blind treatment
Change in the Conduct Problem subscale of the Nisonger Child Behavior Rating Form (N-CBRF) at end of treatment compared with baseline.
Change from baseline to end of double-blind treatment on the total BEHAVE-AD score.
Change from baseline in a composite self-rating of the four most troubling symptoms identified at baseline.
Risperidone effectiveness is measured by time to relapse within the 52 week period.
Change in the Conduct Problem subscale of the Nisonger Child Behavior Rating Form (N-CBRF) at end of treatment compared with baseline
Usefulness of the Risperdal® Consta® Treatment Guidebook; patient and clinician adherence to guidelines
Percent of patients showing clinical improvement, defined as a >=20% reduction in the total PANSS score from baseline to end of double-blind treatment, and the mean change from baseline to end of double-blind treatment in total PANSS score.
Reduction of >= 30% from baseline to the end of double-blind treatment on the total BEHAVE-AD score.
PK parameters (Cmax and AUC) for active moiety, 9-OH-risperidone and risperidone

Secondary Endpoints

The changes from baseline in the subscale scores of Aberrant Behavior Checklist-Japanese Version (ABC-J) at each evaluation of the double-blind phase
Baseline, Week 2, Week 4, Week 6
The changes from baseline in the subscale scores of Aberrant Behavior Checklist-Japanese Version (ABC-J) at each evaluation of the open-label phase
Baseline, Week 2, Week 4, Week 8, Week 16, Week 24, Week 32, Week 40, Week 48
The changes from baseline in scores of the Clinical Global Impression - Severity (CGI-S) at each evaluation time point of the double-blind phase
Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 8
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RisperidoneEXPERIMENTALSubjects weighing less than 20 kilogram (kg) received risperidone 0.25 milligram per day (mg/day) up to Day 4. On Day 4, dose was titrated in increments of 0.25 mg/day (up to a daily dose of 1.0 mg) at the regular study visit thereafter till Week 8. Subjects weighing greater than or equal to (\>=) 20 kg received risperidone 0.5 mg/day up to Day 4. On Day 4, dose was titrated in increments of 0.5 mg per day (up to a daily dose of 2.5 mg) at the regular visit thereafter till Week 8. The maximum daily dose for subjects weighing \>= 45 kg was 3.0 mg. For subjects weighing \>=45 kg, the maximum daily dose was 3.0 mg.
PlaceboPLACEBO_COMPARATORSubjects will receive placebo matching with risperidone orally up to 8 weeks.
Risperidone, long-acting injectableEXPERIMENTAL -

Interventions

NameTypeDescription
RisperidoneDRUGSubjects weighing less than 20 kilogram (kg) received risperidone 0.25 milligram per day (mg/day) up to Day 4. On Day 4, dose was titrated in increments of 0.25 mg/day (up to a daily dose of 1.0 mg) at the regular study visit thereafter till Week 8. Subjects weighing greater than or equal to (\>=) 20 kg received risperidone 0.5 mg/day up to Day 4. On Day 4, dose was titrated in increments of 0.5 mg per day (up to a daily dose of 2.5 mg) at the regular visit thereafter till Week 8. The maximum daily dose for subjects weighing \>= 45 kg was 3.0 mg. For subjects weighing \>=45 kg, the maximum daily dose was 3.0 mg.
PlaceboDRUGSubjects will receive placebo matching with risperidone orally up to 8 weeks.
Risperidone, long-acting injectableDRUG -
Risperidone, oral tabletsDRUG -
Risperidone oral solutionDRUG -
risperidone oral tabletsDRUG -
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Eligibility Criteria

Age Range5 Years to 17 Years
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * Diagnostic for autistic disorder * A Clinical Global Impression - Severity (CGI-S) score of =\>4 and an Aberrant Behavior Checklist - Japanese Version (ABC-J) Irritability Subscale score of =\>18 * Patients with mental age of \>18 months as measured by appropriate developmenta...

Countries:JapanUnited States
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Competitive Landscape -Anxiety Disorders 30 trials

CompanyTickerTrialsLead PhaseDrugs
Definium Therapeutics, Inc.DFTX2PHASE3DT120
Vistagen Therapeutics, Inc.VTGN3PHASE3Fasedienol
Vanda Pharmaceuticals Inc.VNDA1PHASE3VQW-765
AbbVie, Inc.ABBV1PHASE2ABBV-932, Antidepressant Therapy
Masimo CorporationMASI1PHASE1Diprivan, Astra-Zeneca
Psyence Biomedical Ltd.PBM1PHASE2Psilocybin therapy
Neuronetics, Inc.STIM2 - Undisclosed
Aura Biosciences IncAURA1 - Undisclosed
Cooper Companies, Inc.COO1N/AUndisclosed
Vera Therapeutics, Inc. Class AVERA1N/AUndisclosed
Design Therapeutics, Inc.DSGN1N/AUndisclosed
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