Clinical trial NCT01685931: A Study of Paliperidone Palmitate in Patients With Schizophrenia Previously Unsuccessfully Treated by Oral Antipsychotics
Official title: Effectiveness, Safety and Tolerability of Flexibly Dosed Paliperidone Palmitate in Patients With Schizophrenia Previously Unsuccessfully Treated by Oral Antipsychotics and With Acute Symptom of Schizophrenia: A 13-Week, Open-label, Single-arm, Multicenter, Prospective, Interventional Study Followed by a Naturalistic Additional 1 Year Follow up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Paliperidone Palmitate
Oral Antipsychotics
Invega Sustenna
Lead sponsor: Xian-Janssen Pharmaceutical Ltd.
Sponsor class: INDUSTRY
First posted: 2012-09-14
Enrollment: 617
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effectiveness, safety and tolerability of flexibly dosed paliperidone palmitate in patients with schizophrenia previously unsuccessfully treated by oral antipsychotics and with acute symptom of schizophrenia.

Detailed description: This is a 13-week, open-label (all people know the identity of the intervention), single-arm (one group of patients), multicenter, prospective, interventional study in Chinese patients. In a prospective, interventional study, the patients identified receive a treatment during the course of the research study and are followed forward in time for the outcome of the study. In China, there is still insufficient information about effectiveness, tolerability, and dosage strategy for directly switching from previous oral antipsychotics (drugs that are helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders) in patients with acute symptoms. Acute symptoms are quick and severe form of illness in its early stage. In addition, there is also lack of information about bridging acute phase to long-term treatment. In this study, patients with multiple types of acute schizophrenia will be recruited and will receive Sustenna (paliperidone palmitate) treatments for 13 weeks. After the acute treatment, the patients will continue to receive the prescribed medication and will be followed up for an additional 52 weeks to assess the outcomes related to long-term treatment.

Eligibility criteria: Inclusion Criteria:

* Previous diagnosis of schizophrenia
* Experiencing an acute episode, with a Positive and Negative Syndrome Scale (PANSS) total score between 70 and 120, inclusive
* Patients currently treated with antipsychotic are allowed to be recruited
* Be medically stable on the basis of clinical laboratory tests performed at screening

Exclusion Criteria:

* A primary diagnosis other than schizophrenia
* History of risperidone or paliperidone resistance as defined by failure to respond to 2 adequate treatment periods
* Clozapine use for treatment refractory schizophrenia
* Relevant history or current presence of any significant or unstable condition, disease or illness that could limit the participation in the study according to the investigator
* Woman who is pregnant, breast-feeding, or is planning to become pregnant within 6 months

Primary outcomes:
measure: The percentage of patients with a 30% reduction from baseline in Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline, Week 13
Secondary outcomes:
measure: The change from baseline in Positive and Negative Syndrome Scale (PANSS) score
timeFrame: Baseline, Week 13
measure: The change from baseline in Clinical Global Impression - Severity (CGI-S)
timeFrame: Baseline, Week 13
measure: The change from baseline in Medication Satisfaction Questionnaire (MSQ)
timeFrame: Baseline, Week 13
measure: The change from baseline in Involvement Evaluation Questionnaire (IEQ)
timeFrame: Baseline, Week 13
measure: The change from baseline in Medication Adherence Rating Scale (MARS)
timeFrame: Baseline, Week 13
measure: The change from baseline in Medication Preference Questionnaire (MPQ)
timeFrame: Baseline, Week 13
Other outcomes:
Locations:
city: Baoding
country: China
city: Beijing
country: China
city: Chengdu
country: China
city: Chongqing
country: China
city: Fuzhou
country: China
city: Guangzhou
country: China
city: Hangzhou
country: China
city: Jinan
country: China
city: Nanjing
country: China
city: Qingdao
country: China
city: Shantou
country: China
city: Shenzhen
country: China
city: Shijiazhuang
country: China
city: Suzhou
country: China
city: Taiyuan
country: China
city: Tianjin
country: China
city: Wuhan
country: China
Study officials:
affiliation: Xian-Janssen Pharmaceutical Ltd.
name: Xian-Janssen Pharmaceutical Ltd., China Clinical trial
role: STUDY_DIRECTOR
References: