Schizoaffective disorder MedDRA version: 8.1 Level: LLT Classification code 10039621 Term: Schizoaffective disorder
Conditions
Interventions
Product Name: Paliperidone ER
Product Code: R076477
Pharmaceutical Form: Capsule*
INN or Proposed INN: Paliperidone
CAS Number: 144598-75-4
Current Sponsor code: R076477
Concentration unit: mg milligr
Sponsors
Janssen L.P.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject must be, in the opinion of the investigator, able to understand the informed consent form approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC), as appropriate. All 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. In addition, reasonable efforts should be made to provide information about the study to a subject’s designated contact person. Note: It is acceptable to have additional signatures if required by local regulations. In addition, where permitted, if a subject has an appointed legal representative, both the representative and the subject will sign the form. Subjects who are unable to provide their own consent or who have been involuntarily committed to psychiatric hospitalization are not eligible to enroll in the study 2. Subjects may be male or female. 3. Age must be between 18 and 65 years, inclusive 4. Women must be postmenopausal for at least 1 year, 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, contraceptive injections, intrauterine devices, double-barrier method, contraceptive patch, and male partner sterilization). Female subjects must also have a negative urine pregnancy test at screening and baseline (Day 0). 5. Subjects must have lifetime and current diagnosis of schizoaffective disorder (DSM-IV 295.70), as confirmed by the SCID at screening 6. Subjects must be experiencing an acute exacerbation, with a PANSS total score greater than or equal to 60 at the time of study enrollment and at time of randomization 7. The onset of current episode (exacerbation of symptoms) must be no less than 4 days and no more than 4 weeks prior to screening 8. At screening and at randomization, subjects must have a score of ?4 on at least 2 of the following PANSS items: Hostility (P7), Excitement (P4), Tension (G4), Uncooperativeness (G8), and Poor Impulse Control (G14) 9. At screening and at randomization, subject must have a score of >=16 on YMRS OR a score of greater than or equal to 16 on the HAM-D 21 10. Subjects must be hospitalized or be willing to be hospitalized at the time of screening 11. Subjects must be healthy on the basis of physical examinations, electrocardiogram (ECG), laboratory tests, medical history, and vital signs measurements 12. Subjects must be able, in the opinion of the investigator, to be compliant with self-administration of medication or have consistent help/support available. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant (as confirmed by urine pregnancy test performed at screening and baseline), planning to become pregnant, or breast-feeding 2. Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator 3. Subjects with a urine drug screen that is positive for cocaine, opiates, PCP or amphetamines at screening or baseline 4. Subjects with an inability to swallow the study medication whole with the aid of water (subjects must not chew, divide, dissolve, or crush the study medication, as this may affect the release profile) b. Psychiatric history 5. Subjects meeting the DSM-IV criteria for major depressive disorder (diagnostic categories 296.2x and 296.3x), bipolar disorder (diagnostic categories 296.0x, 296.40, 296.4x, 296.5x, 296.6x, 296.7, and 296.89), or schizophrenia (diagnostic categories 295.10, 295.20, 295.30, 295.60, and295.90),or schizophreniform disorder (diagnostic category 295.40). 6. Subjects currently meeting criteria for any other Axis I diagnosis except substance abuse 7. Subjects meeting the DSM-IV criteria for substance dependence in the 6 months before study entry 8. Subjects with an Axis II diagnosis of Mental Retardation or Borderline Personality Disorder 9. Subjects who have attempted suicide within 12 months before study entry or are at imminent risk of suicide according to the investigator’s clinical judgment 10. First-episode subjects (no prior history of psychotic symptoms) c. Treatment history 11. Subjects receiving therapy with antidepressants or mood stabilizers that has been initiated and/or changed in dose 2 clinical studies within the last 12 months 15. Subjects receiving depot antipsychotics, including long-acting injectable risperidone and paliperidone palmitate, within 2 treatment cycles of screening visit 16. Subjects with a history of neuroleptic malignant syndrome 17. Subjects with a previous history of lack of response to antipsychotic medication. Lack of response is defined as the subject having had (at least twice) a documented medical history of no clinical response, despite adequate doses and durations of treatment, or the inability to tolerate effective doses. 18. Subjects receiving therapy with clozapine or having received therapy with clozapine within 3 months prior to randomization 19. Subjects receiving therapy with carbamazepine and monoamine oxidase inhibitors d. Somatic history 20. Subjects with a serious neurological disease, including but not limited to Alzheimer’s disease, vascular dementia, Parkinson’s disease, unstable seizure disorder, intracranial lesions, hydrocephalus, or significant head trauma 21. Relevant history of or current presence of any significant and/or unstable cardiovascular, respiratory, neurological (including seizures or significant cerebrovascular), renal, hepatic, hematologic, endocrine (including untreated or unstable hypo/hyperthyroidism unless stabilized on an appropriate medication for
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to evaluate the efficacy of flexible dose paliperidone ER (3 to 12 mg/day, in 3 mg/day increments), compared with placebo in the treatment of acutely ill subjects with schizoaffective disorder as measured by Positive and Negative Syndrome Scale (PANSS) total score. The safety and tolerability of paliperidone ER in subjects with schizoaffective disorder will also be assessed.;Secondary Objective: Secondary objectives are listed below • Assessment of the rate of response to paliperidone ER among subjects with schizoaffective disorder. Response is defined as a composite of a greater than or equal to 30% reduction from baseline in the PANSS total score and a Clinical Global Impression-Change Scale (CGI-C) • Evaluation of the effects of paliperidone ER on mood symptoms in subjects with schizoaffective disorder, as measured by relevant PANSS factor scores (hostility/excitement and depression/anxiety) ;Primary end point(s): Primary Efficacy Measure The PANSS has been chosen as the primary efficacy measure in this study because it assesses a number of symptom domains relevant to diagnosis and treatment of this disorder. The PANSS is a measure of the severity of 30 symptoms related to schizophrenia as rated by clinicians.19 Numerous studies have shown the PANSS to have strong psychometric properties, including good inter-rater reliability, internal consistency, and construct validity. The PANSS is frequently used as the primary endpoint in schizophrenia studies and is sensitive to global symptomatic changes, in addition to specific domains. Schizoaffective disorder is characterized by core symptoms of schizophrenia with prominent mood symptoms, which can be manic, depressive, or mixed. Analyses of pooled data from 6 studies with olanzapine demonstrated similar PANSS factor structure in subjects with schizophrenia, those with bipolar disease, and those with schizoaffective disorder. In addition to core characteristics o | — |
Countries
Bulgaria
Outcome results
None listed