NCT00056498

Brief Summary

This study will determine whether adding the drug risperidone (Risperdal®) is more effective than placebo in treating schizophrenic patients who are taking the drug clozapine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for phase_4 schizophrenia

Timeline
Completed

Started Dec 2001

Longer than P75 for phase_4 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 17, 2003

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

July 16, 2012

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

6 years

First QC Date

March 14, 2003

Results QC Date

March 23, 2009

Last Update Submit

September 23, 2019

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Positive Symptom Item Scores by Week and Treatment Group

    The Brief Psychiatric Rating Scale (BPRS) positive symptom items are: conceptual disorganization, hallucinatory behavior, unusual thought content, and suspiciousness. The total score is calculated by adding the scores for each item. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum score is 4 and the maximum score is 28. A higher score indicates a more severe positive symptom rating. A mixed model for unbalanced repeated measures analysis of covariance (ANCOVA), in which follow-up symptom score = baseline symptom score + treatment + week + treatment x week, and week is treated as a categorical, rather than a continuous measure. The treatment term estimates the average across weeks of the week-specific group differences, and is used as the main test for treatment effects on symptom change.

    Baseline and every two weeks for 16 weeks.

Secondary Outcomes (2)

  • Neuropsychological Testing - Overall Composite Z-score

    Baseline and Week 16

  • Negative Symptom Total Score by Week and Treatment Group

    Baseline and every two weeks for 16 weeks.

Study Arms (2)

Active

ACTIVE COMPARATOR

Participants assigned to risperidone

Drug: Risperdal

Placebo

PLACEBO COMPARATOR

Participants assigned to placebo

Drug: Placebo

Interventions

PlaceboDRUG

Placebo capsule daily for 16 weeks

Placebo
RisperdalDRUG

Risperdal 4 mg per day for 16 weeks

Also known as: Risperidone
Active

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • DSM-IV criteria for schizophrenia or schizoaffective disorder
  • Current clozapine treatment
  • Moderate illness severity and inadequate positive symptom response to clozapine treatment
  • month period of clozapine treatment with documented clozapine blood level greater than or equal to 350 ng/ml or clozapine and norclozapine blood level greater than or equal to 450 ng/ml

You may not qualify if:

  • Organic brain disorder
  • Mental retardation
  • Medical condition whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol
  • Pregnancy
  • DSM-IV criteria for current alcohol or substance dependence within the last 6 months or DSM-IV criteria for alcohol or substance abuse within the last month
  • Previously received adjunctive risperidone (at doses greater than or equal to 8 mg/day) with their clozapine treatment for greater than or equal to 6 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maryland Psychiatric Research Center

Catonsville, Maryland, 21228, United States

Location

Related Publications (1)

  • Weiner E, Conley RR, Ball MP, Feldman S, Gold JM, Kelly DL, Wonodi I, McMahon RP, Buchanan RW. Adjunctive risperidone for partially responsive people with schizophrenia treated with clozapine. Neuropsychopharmacology. 2010 Oct;35(11):2274-83. doi: 10.1038/npp.2010.101. Epub 2010 Jul 21.

    PMID: 20664583DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Robert W. Buchanan, MD
Organization
Maryland Psychiatric Research Center
rwbuchanan@mprc.umaryland.edu
410-402-7876

Study Officials

  • Robert W Buchanan, MD

    University of Maryland, College Park

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

March 14, 2003

First Posted

March 17, 2003

Study Start

December 1, 2001

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

October 1, 2019

Results First Posted

July 16, 2012

Record last verified: 2019-09

Locations

US(1)