A Study to Evaluate the Efficacy of Paliperidone Palmitate in the Prevention of Relapse of the Symptoms of Schizoaffective Disorder
Condition: Schizoaffective Disorder
MeSH terms: Recurrence; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy of paliperidone palmitate compared with placebo in the
      delay of relapse of the symptoms of schizoaffective disorder. This study will also assess the
      safety and tolerability of paliperidone palmitate in patients with schizoaffective disorder.
    

Detailed description: 
      Schizoaffective disorder is a chronic illness and generally requires life-long treatment. To
      date however, no medication has been evaluated in the maintenance treatment of
      schizoaffective disorder. This is a randomized (study drug assigned by chance), double-blind
      (neither physician nor patient knows the name of the assigned drug), placebo-controlled,
      parallel-group, multicenter study to evaluate the efficacy and safety of paliperidone
      palmitate, as monotherapy or as an adjunct to mood stabilizers or antidepressants, relative
      to placebo in delaying the time to relapse in patients with schizoaffective disorder. This
      study explores the use of paliperidone palmitate either as monotherapy or as an adjunct to
      mood stabilizers or antidepressants (MS/AD) because both treatment approaches are commonly
      used in the clinical management of schizoaffective disorder. Patients with acute symptoms of
      schizoaffective disorder will be enrolled. The study will consist of 4 periods: an up to 7
      days screening/tolerability period, a 13-week open-label flexible dose lead-in period, a
      12-week open-label fixed dose stabilization period, and a 15 months double-blind relapse
      prevention period. Patients without previous exposure to paliperidone ER (Invega),
      paliperidone palmitate (Invega Sustenna), risperidone, or RISPERDAL CONSTA will be given 4 to
      6 days of paliperidone ER 6mg/day for tolerability testing. Patients can continue their
      current antipsychotic regimen through Day -1 (the day before the start of the study period).
      During the open-label periods, all patients will be treated with paliperidone palmitate. An
      initial loading dose of 234 mg (150 mg eq.) of paliperidone palmitate will be given by
      deltoid injection followed by 156 mg (100 mg eq.) deltoid injection on Day 8. Starting on Day
      36, injections may be administered in either the deltoid muscle or the gluteal muscle. Doses
      at Days 36, 64 and 92 may be increased or decreased within the range of 78 mg (50 mg eq.) and
      234 mg (150 mg. eq.) as clinically indicated. Dose will be fixed (at Day 92 dose) during the
      12-week stabilization period. Patients who meet pre-determined stabilization criteria will be
      eligible to enter the double-blind relapse prevention period and will be randomly assigned to
      either receive paliperidone palmitate (at the Day 92 dose) or placebo treatment. Patients
      will have intramuscular (i.m.) study drug injection and efficay and saftety evaluations
      performed every 4 weeks throughout the study. Efficacy will be evaluated during the study
      using a relapse assessment, the Positive and Negative Symptom Scale (PANSS), the Clinical
      Global Impression of Severity for Schizoaffective Disorder (CGI-S-SCA), the Personal and
      Social Performance Scale (PSP), the Young Mania Rating Scale (YMRS), and the Hamilton Rating
      Scale for Depression (HAM-D). Safety will be assessed throughout the study by monitoring of
      adverse events, clinical laboratory tests, electrocardiograms (ECGs), vital sign measurements
      (temperature, pulse, and blood pressure), weight, and the monitoring of extrapyramidal
      symptoms using the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A). Suicidality will
      be assessed by the Columbia Suicide Severity Rating Scale (C-SSRS). A 10 milliliter
      pharmacogenomic blood sample (sample for DNA research) will be collected from patients who
      give separate written informed consent for this part of the study. Participation in
      pharmacogenomic research is optional. Blood samples will be taken from patients being treated
      with lithium or valproate for the measurement of blood lithium or valproate levels.
      Approximately 52 mL (31 mL for patients who are not receiving lithium or valproate) of whole
      blood will be collected during the study. All patients will receive paliperidone palmitate
      78, 117, 156, 234 mg (50, 75, 100, or 150 mg eq.) monthly by i.m. injection for the the first
      25 weeks of the study (open-label periods). During the 15-month double-blind relapse
      prevention period, one half of the patients will be randomized to paliperidone palmitate
      treatment (50, 75, 100, or 150 mg eq. monthly i.m. injection) and the other half of the
      patients will be randomized to monthly placebo injection.
    

Intervention name(s): Placebo; paliperidone palmitate
Intervention type(s): Drug; Drug
Intervention description(s): monthly by i.m. injection for 15 months; 78, 117, 156, 234 mg (50, 75, 100, or 150 mg eq.) monthly by i.m. injection for 15 months
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: schizoaffective disorder; paliperidone palmitate; INVEGA SUSTENNA; schizoaffective disorder relapse prevention