Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Patients With Schizophrenia

NCT01724359 | Completed Phase 4 Results

• 3 other identifiers: CR017413R076477SCH3029R076477SCH3036
• Study Type: interventional
• Target: 95
• Locations: 2 countries
• Sites: 5

Brief Summary

The purpose of this study is to evaluate efficacy, safety and tolerability of flexible, once-daily doses of paliperidone extended-release (ER) in patients with schizophrenia from Argentina and Colombia that previously failed treatment with other antipsychotic agents.

Conditions

Schizophrenia

Keywords

Schizophrenia; Paliperidone extended-release (ER); Antipsychotic agents

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score

  The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.

  Baseline, Week 26

Secondary Outcomes (8)

• Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score

  Baseline, Week 26

• Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score

  Baseline, Week 26

• Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score

  Baseline, Week 26

• Clinical Global Impression-Severity (CGIS)

  Baseline, Week 26

• Personal and Social Performance (PSP) Scale

  Baseline, Week 26

Study Arms (1)

Paliperidone ER

EXPERIMENTAL

Drug: Paliperidone ER

Interventions

Paliperidone ER DRUG

The recommended Paliperidone extended-release (ER) dose will be 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily. Adjustment of the dosage will be done at the investigator's discretion.

Paliperidone ER

Eligibility Criteria

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

You may qualify if:

• Patient meets the criteria for schizophrenia
• Patient is previously non-acute and has been given an adequate dose of an appropriate oral antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication
• Patient is healthy on the basis of a physical examination and vital signs at screening
• Women must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study

You may not qualify if:

• Patients on clozapine, any conventional depot neuroleptic or risperidone long-acting injections during the last 3 months
• Patients with serious unstable medical condition, including known clinically relevant laboratory abnormalities
• Patients with history or current symptoms of tardive dyskinesia and neuroleptic malignant syndrome
• Patients judged to be at high risk for adverse events, violence, or self-harm
• Patients with known hypersensitivity to paliperidone ER or to risperidone
• Patients with a current use or known history (over the past 6 months) of substance dependence

Sponsors & Collaborators

• Janssen-Cilag, S.A.: lead

Study Sites (5)

Unknown Facility

Buenos Aires, Argentina

Location

Unknown Facility

Rosario, Argentina

Location

Unknown Facility

Bogotá, Colombia

Location

Unknown Facility

Cali, Colombia

Location

Unknown Facility

Medellín, Colombia

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: GERENTE MEDICO REGIONAL
• Organization: Jan-Cil Mexico

52 55 5237 3410

Study Officials

• Janssen-Cilag S.A. Clinical Trial

  Janssen-Cilag, S.A.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: November 7, 2012
• First Posted: November 9, 2012
• Study Start: February 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: March 15, 2013
• Results First Posted: March 15, 2013

Record last verified: 2013-02

Locations

AR (2); CO (3)