Schizophrenia Clinical Trial
— PALMFlexSOfficial title:
A 6-month, Open Label, Prospective, Multicenter, International, Exploratory Study of a Transition to Flexibly Dosed Paliperidone Palmitate in Patients With Schizophrenia Previously Unsuccessfully Treated With Oral or Long-acting Injectable Antipsychotics
This study explores the tolerability, safety and efficacy (i.e. how well the drug works) of flexibly dosed paliperidone palmitate in the treatment of schizophrenia in patients previously unsuccessfully treated with other oral or long-acting injectable (LAI) (i.e. with a long duration of action) antipsychotics.
Status | Completed |
Enrollment | 1044 |
Est. completion date | November 2013 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Meet the DSM-IV criteria for schizophrenia Currently non-acute, i.e., on the same antipsychotic medication used for the treatment of schizophrenia given in an adequate dose and a CGI-S change <= 1 in the past 4 weeks before enrollment Patient has been given an adequate dose of either an appropriate oral antipsychotic, or a protocol-defined LAI antipsychotic for an adequate period of time prior to enrollment, but current treatment is considered unsuccessful OR Patients with acute symptoms of schizophrenia, previously treated with an oral antipsychotic, having a baseline total Positive and Negative Syndrome Scale (PANSS) score >= 80 and a baseline CGI-S score >= 4 Women must be postmenopausal for at least 1 year, surgically sterile, abstinent (at the discretion of the investigator/per local regulations), or if sexually active, be practicing a highly effective method of birth control as local regulations permit, and before entry, must agree to continue to use the same method of contraception throughout the study Is cooperative and reliable, and agrees to receive regular injections and complete all aspects of the protocol Men must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug. Exclusion Criteria: The patient's psychiatric diagnosis is due to direct pharmacological effects of a substance (e.g., a drug of abuse or medication) or a general medical condition (e.g., clinically notable hypothyroidism) First antipsychotic treatment ever, i.e., patient has never been treated with antipsychotics before and antipsychotic treatment given in this study will be the first antipsychotic treatment that the patient will have ever received On clozapine during the last 3 months Patients who remain at imminent risk of suicide even after clinical intervention Serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Janssen-Cilag International NV |
Austria, Belgium, Croatia, Denmark, Estonia, France, Germany, Greece, Hungary, Israel, Latvia, Lithuania, Netherlands, Portugal, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improved efficacy for non-acute patients transitioned due to lack of efficacy, as measured by the total PANSS score at endpoint versus baseline. | Baseline to 6 months or early discontinuation | No | |
Primary | Improved efficacy for acute patients, as measured by the total PANSS score at endpoint versus baseline. | Baseline to 6 months or early discontinuation | No | |
Primary | Maintained efficacy for non-acute patients transitioned for other reasons based on PANSS score at endpoint versus baseline. | Baseline to 6 months or early discontinuation | No | |
Secondary | Change from baseline in Clinical Global Impression-Severity Scale [CGI-S] | Baseline, week 1, month 1, 2, 3 and 6 | No | |
Secondary | Change from baseline in personal and social functioning (Personal and Social Performance Scale [PSP]) | Baseline, week 1, month 1, 2, 3 and 6 | No | |
Secondary | Change from baseline in Health status (Self-reported health status questionnaire [SF-36]) | Baseline, month 3 and 6 | No | |
Secondary | Change from baseline in Measure of Health Outcome (EQ-5D) | Baseline, month 3 and 6 | No | |
Secondary | Change from baseline in Patient well-being (Subjective Well-Being under Neuroleptics Scale [SWN-S]); | Baseline, month 3 and 6 | No |
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