Evaluation of Effectiveness of Risperdal® Consta® Compared to Abilify® Over a Two-year Period in Patients With Schizophrenia

NCT00299702 | Completed Phase 4 Results DMC

• 2 other identifiers: CR006121RISSCH4060
• Study Type: interventional
• Target: 355
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the effectiveness of two antipsychotic medications, Risperdal® Consta® versus Abilify®, over a 2-year treatment period in the long-term maintenance of patients with schizophrenia.

Conditions

Schizophrenia; Psychotic Disorders

Keywords

Schizophrenia; Relapse; Remission; Treatment Outcome; long-acting injectable

Outcome Measures

Primary Outcomes (2)

• Time to Relapse

  Time to relapse was defined as the number of days from the date of first dose to the date of relapse, as determined by the Relapse Monitoring Board.

  Day 1 to relapse

• Time in Remission

  Time in remission for an individual subject was defined as the length of time (in days) that the remission criteria were maintained during the trial. Remission was defined as the simultaneous attainment of a score of 3 (mild), 2 (minimal), or 1 (absent) for all the following individual items from Positive and Negative Syndrome Scale (PANSS): delusions (P1), concept disorganization (P2), hallucinatory behavior (P3), unusual thought content (G9), mannerisms and posturing (G5), blunted affect (N1), passive/apathetic social withdrawal (N4), and lack of spontaneity and flow of conversation (N6).

  Day 1 to last PANSS measurement

Study Arms (2)

002

ACTIVE COMPARATOR

Drug: Abilify

001

EXPERIMENTAL

Drug: Risperidal Consta

Interventions

Abilify DRUG

10-30 mg once daily for 104 weeks

002

Risperidal Consta DRUG

25mg, 37.5mg, or 50mg every 2 weeks for 104 weeks

001

Eligibility Criteria

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

You may qualify if:

• Patients with diagnosis of schizophrenia
• Patient has had at least 2 psychotic relapses in the two years prior to study entry
• patient is not adequately benefiting from their current antipsychotic medication

You may not qualify if:

• Patients that have been hospitalized or had major medication changes within 2 months of study entry
• Patients currently experiencing, or who have experienced worsening of disease symptoms within 2 months of study entry
• Patients currently using clozapine or carbamazepine
• Patients who have undergone electroconvulsive therapy or depot antipsychotic treatment within 6 months prior to study entry
• pregnant or breast-feeding

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Janssen, LP: collaborator

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Recurrence

Interventions

Aripiprazole; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrimidinones; Pyrimidines

Limitations and Caveats

15% of subjects did not meet stability inclusion criteria; many received supplemental antipsychotics post-randomization; biweekly visits may have increased aripiprazole adherence; numerous early dropouts may have led to dependent censoring and bias.

Results Point of Contact

• Title: Therapeutic Area Lead
• Organization: Ortho-McNeil, Inc. N America Pharm CNS/IM

609-730-3693

Study Officials

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

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: March 3, 2006
• First Posted: March 7, 2006
• Study Start: February 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: December 30, 2011
• Results First Posted: March 16, 2010

Record last verified: 2011-12