Health Condition 1: null- Schizoaffective Disorder
Conditions
Interventions
Intervention1: Paliperidone palmitate: 78, 117, 156, 234 mg (50, 75, 100 or 150 mg eq.) monthly by i.m. injection for up to 21 months (6 months open-label and 15 months double-blind)
Control Intervent
Sponsors
OrthoMcNeil Janssen Scientific Affairs
Quintiles Research India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: - DSM-IV diagnosis of schizoaffective disorder - Experiencing an acute exacerbation of psychotic symptoms - A score of more than or equual to 4 on at least 3 of the following 7 PANSS items: Delusions (P1), Hallucinatory behavior (P3), Excitement (P4), Hostility (P7), Tension (G4), Uncooperativeness (G8), and Poor Impulse Control (G14) - A score of more than or equual to 16 on YMRS and/or a score of more than or equual to 16 on the HAM-D-21 - Healthy based on physical examinations, electrocardiogram (ECG), laboratory tests, medical history, and vital signs measurements
Exclusion criteria
Exclusion criteria: - A primary active mental illness diagnosis other than schizoaffective disorder - Have attempted suicide within 12 months or are at imminent risk of suicide or violent behavior - Subjects with first episode of psychosis - Received electroconvulsive therapy in the past 3 months - History of hypersensitivity to or intolerance of paliperidone, risperidone, or 20% Intralipid (placebo) - Received long-acting antipsychotic medication within 2 injection cycles - Received therapy with clozapine within 3 months - A history of neuroleptic malignant syndrome - Previous history of lack of response to antipsychotic medication - Subjects receiving therapy with antidepressants or mood stabilizers that has been initiated and/or changed in dose <30 days prior to screening - Receiving therapy with carbamazepine - Receiving therapy with monoamine oxidase inhibitors - Pregnant, breast-feeding, or planning to become pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention PeriodTimepoint: Monthly during the 15 month double-blind Relapse Prevention Period | — |
Secondary
| Measure | Time frame |
|---|---|
| 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)Timepoint: Up to 15 Months;Change in subject functioning using the Personal and Social Performance Scale (PSP)Timepoint: Up to 15 Months;Change in subject medication satisfaction using the Medication Satisfaction Questionnaire (MSQ)Timepoint: Up to 15 Months;Illness severity change as measured by Clinical Global Impression of Severity for Schizoaffective Disorder (CGI-S-SCA)Timepoint: Up to 15 Months;Symptom change as measured by the Positive and Negative Syndrome Scale (PANSS) total and PANSS factor scoresTimepoint: Up to 15 Months | — |
Countries
Bulgaria, India, Malaysia, Philippines, Romania, Russian Federation, Ukraine, United States of America
Contacts
Public ContactSuchela Srivatsa
Quintiles Research (India) Pvt. Ltd.
Outcome results
None listed