Schizoaffective Disorder MedDRA version: 13.1 Level: PT Classification code 10039621 Term: Schizoaffective disorder System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: Paliperidone Palmitate - suspension for injection - 234 mg
Product Code: F013
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Paliperidone palmitate
CAS Number: 199739
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women >= 18 years of age 2. Subjects must sign the study informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Note: It is acceptable to have additional signatures if required by local regulations. If a subject has an appointed legal representative, both the representative and the subject will sign the form. In addition, if the subject or legally-acceptable representative is unable to read or write, it is acceptable to obtain consent orally with the presence of an impartial witness who should personally date and sign the informed consent form. Subjects who are unable to provide their own consent (in writing or orally) or who have been involuntarily committed to psychiatric hospitalization are not eligible to enroll in the study. 3. Women must be postmenopausal for at least 2 years, surgically sterile, abstinent, or agree to practice an effective method of birth control if they are sexually active before entry and throughout the study (effective methods of birth control include prescription hormonal contraceptives, intrauterine devices, double-barrier method, and male partner sterilization). Women of childbearing potential must have a negative urine pregnancy test result at screening. 4. Subjects must have lifetime and current diagnosis of schizoaffective disorder (DSM-IV 295.70), as confirmed by the SCID at screening. 5. Subjects must be experiencing an acute exacerbation of psychotic symptoms no less than 4 days and no more than 4 weeks in duration prior to screening. 6. At screening, subjects must have a score of =4 on at least 3 of the following 9 PANSS items: Delusions (P1), Conceptual Disorganization (P2), Hallucinatory behavior (P3), Excitement (P4), Suspiciousness/Persecution (P6), Hostility (P7), Tension (G4), Uncooperativeness (G8), and Poor Impulse Control (G14). 7. At screening, subject must have a score of =16 on YMRS and/or a score of =16 on the HAM-D-21. 8. Subjects must be healthy based on physical examinations, electrocardiogram (ECG), laboratory tests, medical history, and vital signs measurements. 9. Body mass index (BMI) [weight (kg)/height (m²)] between 17.0 and 40.0, inclusive. 10. Subjects must be cooperative and reliable, agree to receive regular injections, and be willing and able to adhere to the prohibitions and restrictions specified in this protocol. 11. To participate in the optional pharmacogenomic component of this study, subjects (or their legallyacceptable representative) must have signed the informed consent form for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study (where local regulations permit). Refusal to give consent for this component does not exclude a subject from participation in the clinical study. Stabilization Criteria to Enter double-blind Relapse Prevention Period: In addition, to be eligible for randomization to the double-blind Relapse Prevention Period, all of the following stabilization criteria must be met at each visit during the 12-week Stabilization Period: • PANSS total score =70 • YMRS and HAM-D-21 =12 - A single excursion in mood symptoms (YMRS and/or HAM-D-21 between 13 and 17 and not requiring hospitalization) will be permitted during the first 8 weeks of the Stabilization Period (i.e., up to Day 148/Visit 8). After such an excursion, the subject should be brought in f
Exclusion criteria
Exclusion criteria: 1. Subjects who are unable to provide their own consent (in writing or orally) or are involuntarily committed to a psychiatric hospital. 2. Women who are pregnant (as confirmed by a urine pregnancy test performed at screening), planning to become pregnant, or breast-feeding. 3. Subject is an employee or family member of the investigator or institution. 4. Johnson & Johnson employees or their family members. 5. Subjects with a urine drug screen that is positive for cocaine, opiates, phenylcyclohexylpiperidine (PCP), or amphetamines. Psychiatric history 6. Subjects meeting the DSM-IV criteria for major depressive disorder, bipolar disorder, or schizophrenia 7. Subjects currently meeting criteria for any other Axis I diagnosis except substance abuse. 8. Subjects with an Axis II diagnosis of Mental Retardation or Borderline Personality Disorder. 9. Subjects meeting the DSM-IV criteria for substance dependence (except for nicotine and caffeine dependence) in the 3 months before the screening visit. 10. Subjects who have attempted suicide within 12 months before the screening visit or are at imminent risk of suicide or violent behavior according to the investigator’s clinical judgment. 11. Subjects who are in their first episode of psychosis (no prior history of psychotic symptoms) 12. Subjects with a history of receiving electroconvulsive therapy in the 3 months before the screening visit 13. Subjects with a history of hypersensitivity to or intolerance of paliperidone, risperidone, or 20% Intralipid (placebo) or any of their excipients (eg, soybean oil, egg yolks, phospholipids, glycerol) 14. Subjects who have participated in a clinical investigation or received an experimental therapy within 30 days before the screening visit or have participated in >2 clinical studies within the last 12 months 15. Subjects who previously were enrolled in this study 16. Subjects who received long-acting antipsychotic medication within 2 injection cycles prior to the screening visit 17. Subjects who received therapy with clozapine within 3 months of the screening visit with the exception of low dose clozapine used for treatment of insomnia. 18. Subjects with a history of neuroleptic malignant syndrome 19. Subjects with a previous history of lack of response to antipsychotic medication. Lack of response is defined by failure to respond to 2 adequate trials of different antipsychotic medications; an adequate trial is defined as a minimum of 4 weeks at the subject’s maximum tolerated dose 20 Subjects who are: ? receiving therapy with both MS and AD; or ? receiving therapy with MS or AD that has been initiated or changed in dose within 30 days prior to screening. Exceptions: Subjects who meet the following can enter the study: – have been on a generally stable dose of MS or AD (eg, no more than 5 daily doses differing from the subject’s usual dose within 30 days prior to screening); or – have been essentially free of MS or AD (eg, no more than 5 daily doses of either MS or AD within 30 days prior to screening). 21. Subjects receiving therapy with carbamazepine 22. Subjects receiving therapy with monoamine oxidase inhibitors Somatic history 23. History or presence of circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval, including: - Heart rate 450
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of paliperidone palmitate compared with placebo in the delay of relapse of the symptoms of schizoaffective disorder • To assess the safety and tolerability of paliperidone palmitate in subjects with schizoaffective disorder;Primary end point(s): The primary efficacy endpoint for this study is the time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention Period.;Secondary Objective: • To evaluate symptom change as measured by the Positive and Negative Syndrome Scale (PANSS) total and PANSS factor scores during the double-blind Relapse Prevention Period with paliperidone palmitate compared with placebo • To evaluate illness severity change as measured by Clinical Global Impression of Severity for Schizoaffective Disorder (CGI-S-SCA) during the double-blind Relapse Prevention Period with paliperidone palmitate compared with placebo • To evaluate change in subject functioning using the Personal and Social Performance Scale (PSP) during the double-blind Relapse Prevention Period with paliperidone palmitate compared with placebo • To evaluate change in subject medication satisfaction using the Medication Satisfaction Questionnaire (MSQ) during the double-blind Relapse Prevention Period with paliperidone palmitate compared with placebo ;Timepoint(s) of evaluation of this end point: Time between subject randomization to treatment and the first occurrence of a relapse during the 15-month double-blind Relapse Prevention Period compare paliparidone palmitate treatment with placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): During relapse prevention period, compare paliparidone palmitate treatment with placebo in symptom change as measured by the Positive and Negative Syndrome Scale (PANSS) total and PANSS factor scores, illness severity change as measured by Clinical Global Impression of Severity for Schizoaffective Disorder (CGI-S-SCA), change in subject functioning using the Personal and Social Performance Scale (PSP), change in subject medication satisfaction using the Medication Satisfaction Questionnaire (MSQ), change in mood symptoms as measured by YMRS (in subjects with YMRS>=16 at enrollment) and HAM-D-21 (in subjects with HAM-D-21>=16 at enrollment) and HAM-D-17 (in subjects with HAM-D-17>=16 at enrollment. ;Timepoint(s) of evaluation of this end point: Monthly assessment during 15-month relapse prevention period. | — |
Countries
Bulgaria, India, Malaysia, Philippines, Russian Federation, South Africa, Ukraine, United States
Contacts
Public ContactDong-Jing Fu, M.D., PhD
Ortho-McNeil Janssen Scientific Affairs, LLC
Outcome results
None listed