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

NCT00216671 | Completed Phase 4 Results

• 1 other identifier: CR002257
• Study Type: interventional
• Target: 220
• Locations: 10 countries
• Sites: 31

Brief 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). .

Conditions

Schizophrenia

Keywords

Schizophrenia; intramuscular injection; antipsychotic agents; long-acting risperidone

Outcome Measures

Primary Outcomes (1)

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

  The PANSS is a specific scale for the measurement of the symptoms of schizophrenia. Symptoms of schizophrenia will be assessed using the 30-item PANSS scale. Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme).The total score can range from 30 to 210.

  at baseline and Week 26 or at premature discontinuation

Secondary Outcomes (5)

• Change From Baseline in PANSS Total Score at Week 6

  at baseline and Week 6.

• Change From Baseline in PANSS Total Score at Week 12

  at baseline and Week 12.

• Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S)

  at baseline and endpoint (week 26 or at premature discontinuation).

• Change From Baseline to Endpoint in Global Assessment of Functioning (GAF)

  at baseline and endpoint (week 26 or at premature discontinuation).

• Change From Baseline to Endpoint in Quality of Life Questionnaire SF-12

  at baseline, Weeks 6, 12, and endpoint (week 26 or at premature discontinuation).

Study Arms (2)

001

EXPERIMENTAL

early initiation of treatment with Risperdal Consta 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.

Drug: early initiation of treatment with Risperdal Consta

002

ACTIVE COMPARATOR

routine initiation of treatment with Risperdal Consta 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.

Drug: routine initiation of treatment with Risperdal Consta

Interventions

early initiation of treatment with Risperdal Consta DRUG

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.

001

routine initiation of treatment with Risperdal Consta DRUG

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.

002

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Janssen Pharmaceutica N.V., Belgium: lead

Study Sites (31)

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Copenhagen, Denmark

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Glostrup Municipality, Denmark

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Hjørring, Denmark

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Kolding, Denmark

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Helsinki, Finland

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Vantaa, Finland

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Bar-le-Duc, France

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Beaupuy, France

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Clermont-Ferrand, France

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Colmar, France

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La Seyne-sur-Mer, France

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Mont-Saint-Martin, France

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Athens, Greece

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Chania, Greece

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Thessalonikis, Greece

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Tripoli, Greece

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Bat Yam, Israel

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Pardesiyya, Israel

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Petah Tikva, Israel

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Levanger, Norway

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Ljubljana, Slovenia

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Danderyd, Sweden

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Gothenburg, Sweden

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Huddinge, Sweden

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Stockholm, Sweden

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Trollhättan, Sweden

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Oetwil, Switzerland

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Sankt Urban, Switzerland

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Zurich, Switzerland

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London, United Kingdom

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Norfolk, United Kingdom

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MeSH Terms

Conditions

Schizophrenia

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

Due to the substantial number of protocol deviations (mainly due to prohibited medication), the study did not have the required power to demonstrate non-inferiority in the per protocol population

Results Point of Contact

• Title: EMEA Medical Affairs Director Psychiatry
• Organization: Janssen Cilag Spain

+34 91 7228043

Study Officials

• Janssen Pharmaceutica N.V. Clinical Trial

  Janssen Pharmaceutica N.V.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 22, 2005
• Study Start: November 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: July 19, 2013
• Results First Posted: December 2, 2011

Record last verified: 2013-07

Locations

SE (5); SL (1); DK (4); CH (3); GR (4); IL (3); NO (1); GB (2); FI (2); FR (6)