Clinical trial NCT01662648: Safety, Efficacy and Tolerability Study of Paliperidone Extended-Release (ER) in Participants With Schizophrenia
Official title: An Open-label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Subjects With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Paliperidone
Paliperidone extended-release (ER)
Lead sponsor: Janssen Pharmaceutica
Sponsor class: INDUSTRY
First posted: 2012-08-10
Enrollment: 1117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26
timeFrame: Baseline and Week 26
Secondary outcomes:
measure: Percentage of Participants With Greater Than or Equal to 20 Percent (%) Improvement in PANSS Total Score at Week 26
timeFrame: Week 26
measure: Change From Baseline in PANSS Total Positive Subscale Score at Week 26
timeFrame: Baseline and Week 26
measure: Change From Baseline in PANSS Total Negative Subscale Score at Week 26
timeFrame: Baseline and Week 26
measure: Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 26
timeFrame: Baseline and Week 26
measure: Change From Baseline in Personal and Social Performance (PSP) Scale at Week 26
timeFrame: Baseline and Week 26
measure: Change From Baseline in Sleep Quality at Week 26
timeFrame: Baseline and Week 26
measure: Change From Baseline in Daytime Drowsiness at Week 26
timeFrame: Baseline and Week 26
measure: Number of Participants Within Each Category of Patient Satisfaction Score
timeFrame: Baseline and Week 26
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Pharmaceutica
name: Janssen Pharmaceutica Clinical Trial
role: STUDY_DIRECTOR
References: