NCT00653406

Brief Summary

The purpose of this study is to explore the pharmacokinetic profile and safety after biweekly (every 2-week) intramuscular (IM) injections (6 injections) of risperidone long acting injectable 25, 37.5, or 50 mg/dose in schizophrenic patients. The efficacy of the study medication will also be assessed.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at P25-P50 for phase_1 schizophrenia

Timeline
Completed

Started Nov 2002

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2008

Completed
Last Updated

May 17, 2011

Status Verified

March 1, 2010

First QC Date

April 1, 2008

Last Update Submit

May 16, 2011

Conditions

Schizophrenia

Keywords

SchizophreniaRisperidoneIntramuscular injectionPharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • The max and min plasma concentrations, average plasma concentration, and time to reach the max plasma concentration at steady-state (2 weeks after 6th dose). Safety data for all timepoints will be summarized.

Secondary Outcomes (1)

  • The change at Week 12 from the baseline of the total score, positive symptom score, negative symptom score, total psychiatric score and BPRS scores from the PANSS.

Interventions

Risperidone long acting injectableDRUG

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Japanese patients with a DSM-IV diagnosis of schizophrenia
  • A Positive and Negative Syndrome Scale (PANSS) total score between 60 (included) and 120 (excluded)
  • In- or out-patients (change of institutionalization status during the trial period is allowed).

You may not qualify if:

  • No DSM-IV diagnosis other than schizophrenia
  • No convulsive disorders such as epilepsy
  • No neuroleptic malignant syndrome or physical fatigue associated with dehydration, malnutrition
  • No present illness or history of diabetes or risks of diabetes such as hyperglycemia and obesity
  • No hemorrhagic diathesis.

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

  • Janssen Pharmaceutical K.K. Clinical Trial

    Janssen Pharmaceutical K.K.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 1, 2008

First Posted

April 4, 2008

Study Start

November 1, 2002

Study Completion

October 1, 2003

Last Updated

May 17, 2011

Record last verified: 2010-03