CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 220 enrolled
Drug / intervention
early initiation of treatment with Risperdal Consta +1 moredrug
Likely dose
Risperdal Consta 25–50 mg intramuscular injection every 14 daysAI-extracted
Key inclusion· 5
  • ✓Schizophrenia diagnosed by DSM-IV criteria
  • ✓Acute schizophrenic episode within 2 weeks of study entry
  • ✓Either treatment-naive or on oral/short-acting antipsychotics at registered doses
  • ✓PANSS score ≥80
Key exclusion· 4
  • ✕Other DSM-IV axis I diagnosis besides schizophrenia
  • ✕Known hypersensitivity or prior lack of response to risperidone
  • ✕Pregnant, nursing, or inadequate contraception
  • ✕Alcohol or drug abuse/dependence in the month prior to entry

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00216671
NCT00216671Phase 4Completed
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Early Versus Late Initiation of Treatment With Risperdal Consta in Subjects With Schizophrenia After an Acute Episode

Janssen Pharmaceutica N.V., Belgium·interventional·Posted Sep 22, 2005·Updated Jul 19, 2013

In Brief

A Phase 4 clinical trial evaluating early initiation of treatment with Risperdal Consta and routine initiation of treatment with Risperdal Consta for Schizophrenia. Completed, enrolled 220 participants across 31 sites in 10 countries.

Detailed Summary

The primary objective of this randomized trial was to investigate whether early initiation of treatment with Risperdal Consta after an acute episode was not inferior to the routine approach (oral treatment for 12 weeks followed by treatment with Risperdal Consta). .

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesDenmark, Finland, France, Greece, Israel, Norway, Slovenia, Sweden, Switzerland, United Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartNov 1, 2005
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 20.8 years ago

Interventions

early initiation of treatment with Risperdal Constadrug

25 mg to 50 mg Risperdal Consta intrmuscular injection every 14 days starting at baseline. Treatment with oral antipsychotics or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days.

routine initiation of treatment with Risperdal Constadrug

25 mg to 50 mg Risperdal Consta intrmuscular injection every 14 days starting at week 12. Treatment with oral antipsychotics or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days.