CompletedPhase 4

Long-acting Injectable Risperidone in Patients With Schizophrenia After an Acute Episode

Denmark, Finland220 participantsStarted 2005-11

Plain-language 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). .

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of schizophrenia by criteria of Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV) * acute episode of schizophrenia within 2 weeks of study entry * o subjects currently not treated or treated with oral antipsychotics or short-acting injectable antipsychotics (zuclopenthixol acutard is allowed) at doses not exceeding the registered dose * Positive And Negative Syndrome Scale (PANSS) score \>=80 * Clinical Global Impression - Severity (CGI-S) score \>=5 Exclusion Criteria: * DSM-IV axis I diagnosis other than schizophrenia * known hypersensitivity or lack of response to risperidone * pregnant or nursing females, or those without adequate contraception * alcohol or drug abuse or dependence diagnosed in the last month prior to entry,

What they're measuring

Change in Positive And Negative Syndrome Scale (PANSS) Total Score From Baseline to Endpoint

Timeframe: at baseline and Week 26 or at premature discontinuation

Trial details

NCT IDNCT00216671

SponsorJanssen Pharmaceutica N.V., Belgium

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-12

Results submitted2011-01-07

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