Tolerability, Safety and Treatment Response of Flexible Doses of Paliperidone ER in Acutely Exacerbated Subjects With Schizophrenia - PERTAI

Phase 1

• Conditions: Subjects 18 years of age or older who meet the DSM-IV criteria for schizophrenia, experiencing an acute schizophrenic episode with a PANSS total score at baseline higher or equal as 70 and admitted to hospital for treatment of the acute schizophrenic episode.; MedDRA version: 9.1Level: LLTClassification code 10001065Term: Acute schizophrenia episode; MedDRA version: 9.1Level: LLTClassification code 10001064Term: Acute schizophrenia

• Registration Number: EUCTR2006-006642-34-FR
• Lead Sponsor: Janssen-Cilag International NV, Turnhoutsweg 30, 2340 BEERSE, Belgium

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-07-23
• Study Completion: 2009-05-14
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Subject meets the DSM-IV criteria for schizophrenia;
• Male or female, aged = 18 years;
• Subject must be experiencing an acute schizophrenic episode, with a PANSS total score at baseline greater or equal than 70;
• Subject must be admitted to hospital for treatment of the acute schizophrenic episode and must agree for voluntary hospitalization for at least the first 7 days of the study;
• Subjects or their legally acceptable representatives must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study;
• Female subjects must be postmenopausal (for at least 1 year), surgically sterile, abstinent, or, if sexually active, be practicing and effective method of birth control (e.g. prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study. Female subjects of child-bearing potential must have a negative urine pregnancy test at screening.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• First antipsychotic treatment ever;
• On clozapine or a long-acting injectable antipsychotic during the last 3 months;
• Relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular), renal, hepatic, endocrine, or immunologic diseases, including recent or present clinically relevant laboratory abnormalities (as deemed by the investigator);
• Known clinically relevant abnormal laboratory values or ECG;
• History or current symptoms of tardive dyskinesia;
• History of neuroleptic malignant syndrome;
• Judged to be at high risk for or presence of violence or self-harm;
• Pregnant or breast-feeding female;
• Have received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment;
• Subjects with a narrowing or blockage of their gastro-intestinal tract;
• Inability to swallow the study medication whole with the aid of water (subjects may not chew, divide, dissolve, or crush the study medication, as this may affect the release profile);
• Subjects with a current use or known history (over the past 6 months) of substance dependence according to DSM-IV Criteria;
• Employees of the investigator or study center, persons with direct involvement in the proposed study or other studies under the direction of that investigator or study center, or family members of the employees or the investigator;
• Known hypersensitivity to paliperidone ER or risperidone.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified