NCT00828958

Brief Summary

The purpose of this study is to examine the discontinuation rate of schizophrenia patients receiving multiple sequential 2 mL injections of long acting injectable risperidone (an atypical antipsychotic medication) when administered into the deltoid muscle once every 2 weeks.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at below P25 for phase_3 schizophrenia

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_3 schizophrenia

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

February 1, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 26, 2009

Completed
Last Updated

May 18, 2011

Status Verified

March 1, 2010

First QC Date

January 22, 2009

Last Update Submit

May 17, 2011

Conditions

Schizophrenia

Keywords

schizophreniaRisperidoneLong acting injectableIntradeltoidal injection

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients who discontinued from the study after having received at least 2 deltoid injections will be recorded.

Secondary Outcomes (1)

  • Reasons for discontinuation, patient rated local site injection pain and investigator rated local site injection reaction will be assessed at predefined times throughout the study.

Interventions

Risperidone long-acting injectableDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Chronic schizophrenia of any subtype, according to DSM-IV criteria
  • under current treatment with long-acting injectable risperidone 25 mg or 37.5 mg gluteal injections in an adequate study for at least 2 injections, and in need of a dose increase of long-acting injectable risperidone for clinical reason
  • informed consent signed by the patient
  • patient is otherwise healthy on the basis of a prestudy physical examination and medical history.

You may not qualify if:

  • No DSM IV Axis I diagnosis other than schizophrenia
  • no pregnant or breast feeding women
  • no female subject of childbearing potential without adequate contraception
  • no history of severe drug allergy or hypersensitivity
  • no patients with inadequate mass in the deltoid regions to receive the intramuscular drug injections.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 22, 2009

First Posted

January 26, 2009

Study Start

February 1, 2006

Study Completion

September 1, 2006

Last Updated

May 18, 2011

Record last verified: 2010-03