Safety, Efficacy and Tolerability Study of Paliperidone Extended-Release (ER) in Participants With Schizophrenia

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Paliperidone ER

Study type: Interventional

Funder types: Industry

Identifiers

NCT01662648

R076477SCH3024 (Other Identifier)

CR013534

Details and patient eligibility

About

The purpose of this study is to explore the efficacy of flexibly dosed paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) who were previously unsuccessfully treated with other oral antipsychotics.

Full description

This is a single arm (one group of participants), multi-center, 6-month study to explore the tolerability, safety and efficacy of flexibly dosed paliperidone ER in participants with schizophrenia previously unsuccessfully treated with an oral antipsychotic medication. Antipsychotic medications are drugs that are helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders. Unsuccessfully treated means that, despite the participant was treated with an adequate dose of an appropriate oral antipsychotic for an adequate period of time, previous treatment is considered unsuccessful due to lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons. Throughout the study the investigators will adjust the dosage of each participant based on the individual needs. In general, the recommended paliperidone ER dose will be 6 milligram once daily. Participants can be either in- or outpatients and they may take their study drug with or without food. Participants who will complete this 6-month study and would like to continue will be eligible to be enrolled in an extension phase until paliperidone ER is available.

Enrollment: 1,117 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant diagnosed with schizophrenia
• Participant's previous treatment of schizophrenia is considered unsuccessful
• Participant is healthy on the basis of a physical examination and vital signs
• Women must be postmenopausal, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study
• Be willing and able to fill out self-administered questionnaires

Exclusion criteria

• Have used clozapine or Risperdal CONSTA during the last month, or have received any other conventional drug used to treat psychosis during the last 3 months
• Judged to be at high risk for adverse events, violence or self-harm
• Inability to swallow the study medication whole with the aid of water
• Pregnant or breast-feeding female
• History or current symptoms of tardive dyskinesia (involuntary movements of the facial muscles and tongue)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,117 participants in 2 patient groups

Paliperidone ER: Lack of efficacy

Experimental group

Description:

Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day will be given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.

Treatment:

Drug: Paliperidone ER

Paliperidone ER: Lack of tolerability, compliance or other

Experimental group

Description:

Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day will be given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.

Treatment:

Drug: Paliperidone ER